Hematopoietic and Lymphatic System NeoplasmPhase 3NCT06513962
Triptorelin for the Prevention of Ovarian Damage in Adolescents and Young Adults With Cancer
A Phase 3 study testing Best Practice, Biospecimen Collection and Electronic Health Record Review in people with Hematopoietic and Lymphatic System Neoplasm and Malignant Solid Neoplasm, run by Children's Oncology Group at 206 sites in 2 countries.
Trial summary
This phase III trial compares the effect of giving triptorelin vs no triptorelin in preventing ovarian damage in adolescents and young adults (AYAs) with cancer receiving chemotherapy with alkylating agents. Alkylating agents are part of standard chemotherapy, but may cause damage to the ovaries. Read more about this study
- Who is it for?
- Ages Up to 39 years, women only
- Conditions the study is for
- Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
- What is being tested?
- Best Practice, Biospecimen Collection and Electronic Health Record Review
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 206 sitesin 2 countries
- Study dates
- 27 Feb 2025to 30 Oct 2029
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 39 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- < 40 years of age at the time of enrollment
- Patient must be a post-menarchal female and report that their initial menstrual period occurred > 6 months prior to enrollment. (Current menstrual status is not part of the inclusion criteria.)
- Newly diagnosed with first cancer, exclusive of breast cancer.
- Note: Apart from breast carcinoma, other tumor types originating in the breast are permitted (e.g., sarcoma, lymphoma).
- Planned treatment must include one or more of the following alkylating agents delivered with curative intent: cyclophosphamide, ifosfamide, procarbazine, chlorambucil, carmustine (BCNU), lomustine (CCNU), melphalan, thiotepa, busulfan, nitrogen mustard, or dacarbazine (DTIC).
- Expected cumulative cyclophosphamide equivalent dose (CED):
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- For patients < 20 years of age at enrollment, the expected alkylator dose must be ≥ 4 g/m^2 cumulative CED calculated according to the equation and specified drugs listed. Dacarbazine is not an eligible drug in this age group.
- For patients ≥ 20 years of age and < 35 years old at enrollment, any planned alkylator dose is permitted. Eligible patients must receive at least one of the alkylators listed below that contribute to CED. Dacarbazine is not an eligible drug in this age group.
- For patients ≥ 35 years of age at enrollment, any planned alkylator dose is permitted. Eligible patients must receive at least one of the alkylators listed that contribute to CED and/or dacarbazine, which IS an eligible drug in this age group.
- Note that CED includes all administration routes: intravenous (IV), oral (PO), IM.
- The planned total duration of therapy with eligible alkylators is expected to be completed within one year after enrollment. Note: treatment plans with prolonged maintenance periods extending beyond one year are permitted so long as those maintenance treatments are not expected to contain eligible alkylators.
- All patients and/or their parents or legal guardians must sign a written informed consent.
- All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met.
Who cannot join
- Any planned radiation to the pelvis; or cranial radiation ≥ 30 gray (Gy) to the hypothalamus, inclusive of any total body irradiation (TBI).
- Planned bilateral oophorectomy. Note: A participant's desire to pursue alternative fertility preservation procedures (i.e., embryo, oocyte, or ovarian tissue cryopreservation) will be allowed (and in fact encouraged).
- Congenital syndromes associated with infertility and decreased ovarian reserve at baseline. For example: Turner's Syndrome, Fragile X premutation carriers, Down syndrome, etc.
- Pre-existing seizure disorder, congenital long QT syndrome, pseudotumor cerebri; history of pulmonary embolism, venous thrombosis, or myocardial infarction. Note: Contact study chairs if questions arise about other pre-existing conditions.
- Receipt of long acting (depot) GnRH agonists within 6 months before enrollment. In contrast, subcutaneous GnRH agonist used for oocyte retrieval is not an exclusion; oral and other hormonal contraceptive use is also not an exclusion. Note: Please see protocol for the concomitant therapy restrictions for patients during the study treatment period. See protocol for information about oral and other hormonal contractive use during the study treatment period.
- Receipt of systemic chemotherapy (except for steroids and intrathecal chemotherapy) more than 7 days prior to study enrollment.
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- Any prior radiation to the pelvis; or cranial radiation ≥ 30 Gy to the hypothalamus, inclusive of any total body irradiation (TBI).
- Patients who are pregnant are not eligible. A pregnancy test is required for female patients of childbearing potential.
- Lactating females who plan to breastfeed their infants for the duration of triptorelin therapy (24 weeks per dose).
- Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of triptorelin therapy (24 weeks per dose).
Trial locations and contacts
206 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
206 sites in 2 countries
United States201 sites, 191 recruiting
- Recruiting
Children's Hospital Medical Center of Akron
Akron, Ohio, 44308
Site Public Contact, 330-543-3193
Erin Wright
- Recruiting
Albany Medical Center
Albany, New York, 12208
Site Public Contact, 518-262-5513
Lauren R. Weintraub
- Recruiting
Presbyterian Hospital
Albuquerque, New Mexico, 87106
Site Public Contact, 505-559-6113, wburman@phs.org
Beeling Armijo
- Recruiting
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106
Site Public Contact, 505-925-0348, HSC-ClinicalTrialInfo@salud.unm.edu
Jessica M. Valdez
- Recruiting
OSF Saint Anthony's Health Center
Alton, Illinois, 62002
Site Public Contact, 618-463-5623
Jay W. Carlson
- Recruiting
UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny, Iowa, 50023
Site Public Contact, 515-241-3305
Seema Harichand-Herdt
- Recruiting
C S Mott Children's Hospital
Ann Arbor, Michigan, 48109
Site Public Contact, 800-865-1125
Emily B. Walling
- Recruiting
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109
Site Public Contact, 800-865-1125, CancerAnswerLine@med.umich.edu
Emily B. Walling
- Recruiting
Children's Healthcare of Atlanta - Arthur M Blank Hospital
Atlanta, Georgia, 30329
Site Public Contact, 404-785-0232, Olivia.Floyd@choa.org
Lillian R. Meacham
- Recruiting
Children's Hospital Colorado
Aurora, Colorado, 80045
Site Public Contact, 303-764-5056, josh.b.gordon@nsmtp.kp.org
Jenna M. Demedis
- Suspended
Rush-Copley Medical Center
Aurora, Illinois, 60504
- Recruiting
Mercy Oncology and Hematology - Clayton-Clarkson
Ballwin, Missouri, 63011
Site Public Contact, 888-446-3729
Jay W. Carlson
- Recruiting
Bronson Battle Creek
Battle Creek, Michigan, 49017
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Recruiting
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889-5600
Site Public Contact, 301-319-2100
Kip R. Hartman
- Recruiting
Children's Hospital of Alabama
Birmingham, Alabama, 35233
Site Public Contact, 205-638-9285, oncologyresearch@peds.uab.edu
Jamie M. Aye
- Recruiting
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, 35233
Site Public Contact, gingerreeves@uabmc.edu
Vanessa Eulo
- Recruiting
Sanford Bismarck Medical Center
Bismarck, North Dakota, 58501
Site Public Contact, 701-323-5760, OncologyClinicalTrialsFargo@sanfordhealth.org
Samuel J. Milanovich
- Recruiting
Central Care Cancer Center - Bolivar
Bolivar, Missouri, 65613
Site Public Contact, 913-948-5588, aroland@kccop.org
Jay W. Carlson
- Recruiting
Cox Cancer Center Branson
Branson, Missouri, 65616
Site Public Contact, 417-269-4520
Jay W. Carlson
- Recruiting
Mercy Cancer Center - Cape Girardeau
Cape Girardeau, Missouri, 63703
Site Public Contact, 888-446-3729
Jay W. Carlson
- Recruiting
Saint Anthony Regional Hospital
Carroll, Iowa, 51401
Site Public Contact, 515-689-7658, sbenson@iora.org
Seema Harichand-Herdt
- Suspended
Saint Mary's Hospital
Centralia, Illinois, 62801
- Recruiting
Christiana Care Health System-Concord Health Center
Chadds Ford, Pennsylvania, 19317
Site Public Contact, 302-623-4450, lbarone@christianacare.org
Gregory A. Masters
- Recruiting
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
Site Public Contact, 877-668-0683, cancerclinicaltrials@med.unc.edu
Thomas B. Alexander
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Site Public Contact, 843-792-9321, hcc-clinical-trials@musc.edu
Anca Dumitriu
- Recruiting
Lurie Children's Hospital-Chicago
Chicago, Illinois, 60611
Site Public Contact, 773-880-4562
Jennifer L. Reichek
- Recruiting
Northwestern University
Chicago, Illinois, 60611
Site Public Contact, 312-695-1301, cancer@northwestern.edu
Shira N. Dinner
- Recruiting
University of Illinois
Chicago, Illinois, 60612
Site Public Contact, 312-355-3046
Dipti S. Dighe
- Recruiting
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, 63376
Site Public Contact, 800-600-3606, info@siteman.wustl.edu
Nancy L. Bartlett
- Recruiting
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Site Public Contact, 866-223-8100, TaussigResearch@ccf.org
Matteo M. Trucco
- Recruiting
Mercy Cancer Center-West Lakes
Clive, Iowa, 50325
Site Public Contact, 515-241-3305
Richard L. Deming
- Recruiting
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive, Iowa, 50325
Site Public Contact, 515-241-3305
Seema Harichand-Herdt
- Recruiting
Prisma Health Richland Hospital
Columbia, South Carolina, 29203
Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org
Stuart L. Cramer
- Recruiting
Nationwide Children's Hospital
Columbus, Ohio, 43205
Site Public Contact, 614-722-6039, Melinda.Triplet@nationwidechildrens.org
Mark A. Ranalli
- Recruiting
Greater Regional Medical Center
Creston, Iowa, 50801
Site Public Contact, 515-241-3305
Richard L. Deming
- Recruiting
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, 63141
Site Public Contact, 800-600-3606, info@siteman.wustl.edu
Nancy L. Bartlett
- Recruiting
Medical City Dallas Hospital
Dallas, Texas, 75230
Site Public Contact, 972-566-5588
Maurizio L. Ghisoli
- Recruiting
Parkland Memorial Hospital
Dallas, Texas, 75235
Site Public Contact, 214-590-5582, canceranswerline@UTSouthwestern.edu
Ksenya Shliakhtsitsava
- Recruiting
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390
Site Public Contact, 214-648-7097, canceranswerline@UTSouthwestern.edu
Ksenya Shliakhtsitsava
- Suspended
Carle at The Riverfront
Danville, Illinois, 61832
- Recruiting
Dayton Children's Hospital
Dayton, Ohio, 45404
Site Public Contact, 800-228-4055
Jordan M. Wright
- Recruiting
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois, 60115
Site Public Contact, 630-352-5360, Donald.Smith3@nm.org
Shira N. Dinner
- Recruiting
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
Denver, Colorado, 80218
Site Public Contact, 303-832-2344, PSGResearchSharedMailbox@HCAHealthcare.com
Florence Choo
- Recruiting
Blank Children's Hospital
Des Moines, Iowa, 50309
Site Public Contact, 515-241-8912, samantha.mallory@unitypoint.org
Samantha L. Mallory
- Recruiting
Iowa Methodist Medical Center
Des Moines, Iowa, 50309
Site Public Contact, 515-241-6727
Seema Harichand-Herdt
- Recruiting
UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines, Iowa, 50309
Site Public Contact, 515-241-3305
Seema Harichand-Herdt
- Recruiting
Broadlawns Medical Center
Des Moines, Iowa, 50314
Site Public Contact, 515-282-2200
Seema Harichand-Herdt
- Recruiting
Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314
Site Public Contact, 515-241-3305
Richard L. Deming
- Recruiting
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines, Iowa, 50314
Site Public Contact, 515-241-3305
Seema Harichand-Herdt
- Recruiting
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
Site Public Contact, 800-826-4673, becomingapatient@coh.org
Rusha Bhandari
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27710
Site Public Contact, 888-275-3853
Jessica M. Sun
- Suspended
Carle Physician Group-Effingham
Effingham, Illinois, 62401
- Recruiting
El Paso Children's Hospital
El Paso, Texas, 79905
Site Public Contact, 915-298-5444, ranjan.bista@ttuhsc.edu
Benjamin Carcamo
- Recruiting
Christiana Care - Union Hospital
Elkton, Maryland, 21921
Site Public Contact, 410-443-1360, frank.crum@christianacare.org
Gregory A. Masters
- Recruiting
Sanford Broadway Medical Center
Fargo, North Dakota, 58122
Site Public Contact, 701-323-5760, OncologyClinicalTrialsFargo@sanfordhealth.org
Samuel J. Milanovich
- Recruiting
UI Healthcare Mission Cancer and Blood - Fort Dodge
Fort Dodge, Iowa, 50501
Site Public Contact, 515-282-2921, trials@missioncancer.com
Seema Harichand-Herdt
- Recruiting
Golisano Children's Hospital of Southwest Florida
Fort Myers, Florida, 33908
Site Public Contact, 239-343-5333, molly.arnstrom@leehealth.org
Emad K. Salman
- Recruiting
Mercy Hospital Fort Smith
Fort Smith, Arkansas, 72903
Site Public Contact, 800-378-9373
Jay W. Carlson
- Recruiting
Cook Children's Medical Center
Fort Worth, Texas, 76104
Site Public Contact, 682-885-2103, CookChildrensResearch@cookchildrens.org
Karen H. Albritton
- Recruiting
UF Health Cancer Institute - Gainesville
Gainesville, Florida, 32610
Site Public Contact, 352-273-8010, cancer-center@ufl.edu
Brian Stover
- Recruiting
Central Care Cancer Center - Garden City
Garden City, Kansas, 67846
Site Public Contact, 913-948-5588, aroland@kccop.org
Jay W. Carlson
- Recruiting
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, 60134
Site Public Contact, 630-352-5360, Donald.Smith3@nm.org
Shira N. Dinner
- Recruiting
Northwestern Medicine Glenview Outpatient Center
Glenview, Illinois, 60026
Site Public Contact, 312-695-1102
Shira N. Dinner
- Recruiting
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan, 49503
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Recruiting
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
Grand Rapids, Michigan, 49503
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Recruiting
Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan, 49503
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Recruiting
Northwestern Medicine Grayslake Outpatient Center
Grayslake, Illinois, 60030
Site Public Contact, 312-695-1102
Shira N. Dinner
- Recruiting
Central Care Cancer Center - Great Bend
Great Bend, Kansas, 67530
Site Public Contact, 913-948-5588, aroland@kccop.org
Jay W. Carlson
- Recruiting
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, 54301
Site Public Contact, 920-433-8889, WI_research_admin@hshs.org
Catherine A. Long
- Recruiting
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin, 54303
Site Public Contact, 920-433-8889, wi_research_admin@hshs.org
Catherine A. Long
- Recruiting
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Site Public Contact, 551-996-2897
Burton E. Appel
- Recruiting
Connecticut Children's Medical Center
Hartford, Connecticut, 06106
Site Public Contact, 860-545-9981
Michael S. Isakoff
- Recruiting
Penn State Children's Hospital
Hershey, Pennsylvania, 17033
Site Public Contact, 717-531-6012
Lisa M. McGregor
- Recruiting
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood, Florida, 33021
Site Public Contact, 954-265-1847, OHR@mhs.net
Iftikhar Hanif
- Recruiting
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96826
Site Public Contact, 808-983-6090
Wade T. Kyono
- Recruiting
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, 77030
Site Public Contact, 713-798-1354, burton@bcm.edu
Stephanie Fetzko
- Recruiting
UT MD Anderson Cancer Center
Houston, Texas, 77030
Site Public Contact, 866-632-6789, askmdanderson@mdanderson.org
Najat C. Daw
- Recruiting
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202
Site Public Contact, 317-278-5632, iutrials@iu.edu
Tarah J. Ballinger
- Recruiting
Riley Hospital for Children
Indianapolis, Indiana, 46202
Site Public Contact, 800-248-1199
Amanda Saraf
- Recruiting
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242
Site Public Contact, 800-237-1225
Andrew P. Groves
- Recruiting
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Site Public Contact, 601-815-6700
Amanda Strobel
- Recruiting
Nemours Children's Clinic-Jacksonville
Jacksonville, Florida, 32207
Site Public Contact, 302-651-5572, Allison.bruce@nemours.org
Vibhuti Agarwal
- Recruiting
Freeman Health System
Joplin, Missouri, 64804
Site Public Contact, 417-347-4030, LJCrockett@freemanhealth.com
Jay W. Carlson
- Recruiting
Mercy Hospital Joplin
Joplin, Missouri, 64804
Site Public Contact, 417-556-3074, esmeralda.carrillo@mercy.net
Jay W. Carlson
- Recruiting
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Recruiting
West Michigan Cancer Center
Kalamazoo, Michigan, 49007
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Recruiting
Beacon Kalamazoo Cancer Center
Kalamazoo, Michigan, 49009
Site Public Contact, 574-647-7370
Kathleen Y. Butler
- Recruiting
Beacon Kalamazoo
Kalamazoo, Michigan, 49048
Site Public Contact, 574-647-7370
Kathleen Y. Butler
- Recruiting
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, 64108
Site Public Contact, 816-302-6808, COGResearchGroup@cmh.edu
Keith J. August
- Recruiting
UC San Diego Moores Cancer Center
La Jolla, California, 92093
Site Public Contact, 858-822-5354, cancercto@ucsd.edu
H. I. Su
- Recruiting
Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois, 60045
Site Public Contact, cancertrials@northwestern.edu
Shira N. Dinner
- Recruiting
Beebe Medical Center
Lewes, Delaware, 19958
Site Public Contact, 302-291-6730, research@beebehealthcare.org
Gregory A. Masters
- Recruiting
Arkansas Children's Hospital
Little Rock, Arkansas, 72202-3591
Site Public Contact, 501-364-7373
Michael W. Bishop
- Recruiting
CARTI Cancer Center
Little Rock, Arkansas, 72205
Site Public Contact, 501-906-4199, Research@CARTI.com
Jay W. Carlson
- Recruiting
Loma Linda University Medical Center
Loma Linda, California, 92354
Site Public Contact, 909-558-4050
Albert Kheradpour
- Recruiting
Mattel Children's Hospital UCLA
Los Angeles, California, 90095
Site Public Contact, 310-825-6708
Noah C. Federman
- Recruiting
Norton Children's Hospital
Louisville, Kentucky, 40202
Site Public Contact, 502-629-5500, CancerResource@nortonhealthcare.org
Michael J. Ferguson
- Recruiting
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
Madison, Wisconsin, 53718
Site Public Contact, 800-622-8922, clinicaltrials@cancer.wisc.edu
Cathy A. Lee-Miller
- Recruiting
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, 53792
Site Public Contact, 800-622-8922, clinicaltrials@cancer.wisc.edu
Cathy A. Lee-Miller
- Suspended
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938
- Recruiting
Saint Jude Children's Research Hospital
Memphis, Tennessee, 38105
Site Public Contact, 888-226-4343, referralinfo@stjude.org
Kari Bjornard
- Recruiting
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 33136
Site Public Contact, 305-243-2647
Meghan McCormick
- Recruiting
Nicklaus Children's Hospital
Miami, Florida, 33155
Site Public Contact, 888-624-2778
Maggie E. Fader
- Recruiting
Miami Cancer Institute
Miami, Florida, 33176
Site Public Contact, 786-596-2000
Doured Daghistani
- Recruiting
Beebe South Coastal Health Campus
Millville, Delaware, 19967
Site Public Contact, 302-291-6730, research@beebehealthcare.org
Gregory A. Masters
- Recruiting
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226
Site Public Contact, 414-955-4727, MACCCTO@mcw.edu
Kerri Becktell
- Recruiting
Aurora Sinai Medical Center
Milwaukee, Wisconsin, 53233
Site Public Contact, 414-302-2304, ncorp@aurora.org
Rebecca E. McFall
- Recruiting
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis, Minnesota, 55404
Site Public Contact, 612-813-5913, pauline.mitby@childrensmn.org
Michael K. Richards
- Recruiting
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, 55455
Site Public Contact, 612-624-2620
Karim T. Sadak
- Recruiting
USA Health Strada Patient Care Center
Mobile, Alabama, 36604
Site Public Contact, 800-388-8721
Hamayun Imran
- Recruiting
SSM Health Good Samaritan
Mount Vernon, Illinois, 62864
Site Public Contact, 618-899-1894, gayla.hall@ssmhealth.com
Jay W. Carlson
- Recruiting
Trinity Health Muskegon Hospital
Muskegon, Michigan, 49444
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Recruiting
The Children's Hospital at TriStar Centennial
Nashville, Tennessee, 37203
Site Public Contact, 615-342-1919
Clinton M. Carroll
- Recruiting
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232
Site Public Contact, 800-811-8480
Elizabeth J. Davis
- Recruiting
Children's Hospital New Orleans
New Orleans, Louisiana, 70118
Site Public Contact, 504-894-5377
Maria C. Velez-Yanguas
- Recruiting
Ochsner Medical Center Jefferson
New Orleans, Louisiana, 70121
Site Public Contact, 504-842-8084, Elisemarie.curry@ochsner.org
Craig Lotterman
- Recruiting
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, 10032
Site Public Contact, 212-342-5162, cancerclinicaltrials@cumc.columbia.edu
Nobuko Hijiya
- Recruiting
NYP/Weill Cornell Medical Center
New York, New York, 10065
Site Public Contact, 212-746-1848
Alexander J. Chou
- Recruiting
Helen F Graham Cancer Center
Newark, Delaware, 19713
Site Public Contact, 302-623-4450, lbarone@christianacare.org
Gregory A. Masters
- Recruiting
Medical Oncology Hematology Consultants PA
Newark, Delaware, 19713
Site Public Contact, 302-623-4450, lbarone@christianacare.org
Gregory A. Masters
- Recruiting
Christiana Care Health System-Christiana Hospital
Newark, Delaware, 19718
Site Public Contact, 302-623-4450, lbarone@christianacare.org
Gregory A. Masters
- Recruiting
Corewell Health Lakeland Hospitals - Niles Hospital
Niles, Michigan, 49120
Site Public Contact, 616-391-1230
Kathleen Y. Butler
- Recruiting
Carle BroMenn Medical Center
Normal, Illinois, 61761
Site Public Contact, 800-446-5532, Research@Carle.com
Maria T. Grosse-Perdekamp
- Recruiting
Carle Cancer Institute Normal
Normal, Illinois, 61761
Site Public Contact, 800-446-5532, Research@Carle.com
Maria T. Grosse-Perdekamp
- Suspended
Cancer and Hematology Centers of Western Michigan - Norton Shores
Norton Shores, Michigan, 49444
- Recruiting
Advocate Children's Hospital-Oak Lawn
Oak Lawn, Illinois, 60453
Site Public Contact, 847-723-7570
Rebecca E. McFall
- Recruiting
Kaiser Permanente-Oakland
Oakland, California, 94611
Site Public Contact, 877-642-4691, Kpoct@kp.org
Aarati V. Rao
- Recruiting
Saint Vincent Hospital Cancer Center at Oconto Falls
Oconto Falls, Wisconsin, 54154
Site Public Contact, 920-433-8889, WI_research_admin@hshs.org
Catherine A. Long
- Recruiting
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Site Public Contact, 405-271-8777, ou-clinical-trials@ouhsc.edu
Rene Y. McNall-Knapp
- Recruiting
Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma, 73120
Site Public Contact, 405-752-3402
Jay W. Carlson
- Recruiting
Children's Hospital and Medical Center of Omaha
Omaha, Nebraska, 68114
Site Public Contact, 402-955-3949
Jill C. Beck
- Recruiting
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Site Public Contact, 402-559-6941, unmcrsa@unmc.edu
Jill C. Beck
- Recruiting
Children's Hospital of Orange County
Orange, California, 92868
Site Public Contact, 714-509-8646, oncresearch@choc.org
Elyssa M. Rubin
- Recruiting
Northwestern Medicine Orland Park
Orland Park, Illinois, 60462
Site Public Contact, nctnprogram_rhlccc@northwestern.edu
Shira N. Dinner
- Recruiting
AdventHealth Orlando
Orlando, Florida, 32803
Site Public Contact, 407-303-2090, FH.Cancer.Research@flhosp.org
Fouad M. Hajjar
- Recruiting
Nemours Children's Hospital
Orlando, Florida, 32827
Site Public Contact, 302-651-5572, Allison.bruce@nemours.org
Vibhuti Agarwal
- Recruiting
Lake Regional Hospital
Osage Beach, Missouri, 65065
Site Public Contact, 573-302-2768, clinicaltrials@lakeregional.com
Jay W. Carlson
- Recruiting
Advocate Children's Hospital-Park Ridge
Park Ridge, Illinois, 60068
Site Public Contact, helpdesk@childrensoncologygroup.org
Rebecca E. McFall
- Recruiting
UI Healthcare Mission Cancer and Blood - Pella
Pella, Iowa, 50219
Site Public Contact, 515-282-2921, trials@missioncancer.com
Seema Harichand-Herdt
- Recruiting
Nemours Children's Clinic - Pensacola
Pensacola, Florida, 32504
Site Public Contact, helpdesk@childrensoncologygroup.org
Jeffrey H. Schwartz
- Recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Site Public Contact, 267-425-5544, CancerTrials@email.chop.edu
Rebecca Citrin
- Recruiting
Saint Christopher's Hospital for Children
Philadelphia, Pennsylvania, 19134
Site Public Contact, 215-427-8991
Gregory E. Halligan
- Recruiting
Phoenix Childrens Hospital
Phoenix, Arizona, 85016
Site Public Contact, 602-546-0920
Alexandra M. Walsh
- Recruiting
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224
Site Public Contact, 412-692-8570, jean.tersak@chp.edu
Jean M. Tersak
- Recruiting
Oregon Health and Science University
Portland, Oregon, 97239
Site Public Contact, 503-494-1080, trials@ohsu.edu
Susan J. Lindemulder
- Recruiting
Rhode Island Hospital
Providence, Rhode Island, 02903
Site Public Contact, 401-444-1488
Bradley DeNardo
- Recruiting
Corewell Health Reed City Hospital
Reed City, Michigan, 49677
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Recruiting
Beebe Health Campus
Rehoboth Beach, Delaware, 19971
Site Public Contact, 302-291-6730, research@beebehealthcare.org
Gregory A. Masters
- Recruiting
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, 23298
Site Public Contact, 804-628-6430, CTOclinops@vcu.edu
Jordyn R. Griffin
- Recruiting
Carilion Children's
Roanoke, Virginia, 24014
Site Public Contact, 540-266-6238, wpmccarty@carilionclinic.org
Erwood G. Edwards
- Recruiting
University of Rochester
Rochester, New York, 14642
Site Public Contact, 585-275-5830
John L. Mariano
- Recruiting
Mercy Clinic-Rolla-Cancer and Hematology
Rolla, Missouri, 65401
Site Public Contact, 573-458-6379
Jay W. Carlson
- Recruiting
Phelps Health Delbert Day Cancer Institute
Rolla, Missouri, 65401
Site Public Contact, 573-458-7504, research@phelpshealth.org
Jay W. Carlson
- Recruiting
Sutter Medical Center Sacramento
Sacramento, California, 95816
Site Public Contact, clinicalresearch@sutterhealth.org
Sandra Baril
- Recruiting
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
Saint Joseph, Michigan, 49085
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Recruiting
Corewell Health Lakeland Hospitals - Saint Joseph Hospital
Saint Joseph, Michigan, 49085
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Recruiting
Heartland Regional Medical Center
Saint Joseph, Missouri, 64506
Site Public Contact, 816-271-7937, Trisha.England2@mymlc.com
Jay W. Carlson
- Recruiting
Children's Hospital of San Antonio
San Antonio, Texas, 78207
Site Public Contact, 210-704-2894, bridget.medina@christushealth.org
Julie Voeller
- Suspended
UC San Diego Medical Center - Hillcrest
San Diego, California, 92103
- Recruiting
Rady Children's Hospital - San Diego
San Diego, California, 92123
Site Public Contact, 858-966-5934
William D. Roberts
- Recruiting
Maine Children's Cancer Program
Scarborough, Maine, 04074
Site Public Contact, 207-396-8670, clinicalresearch@mainehealth.org
Ashley M. Jean
- Recruiting
MaineHealth Maine Medical Center- Scarborough
Scarborough, Maine, 04074
Site Public Contact, 207-396-8670, clinicalresearch@mainehealth.org
Ashley M. Jean
- Recruiting
Seattle Children's Hospital
Seattle, Washington, 98105
Site Public Contact, 866-987-2000
Sarah E. Leary
- Recruiting
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
Site Public Contact, 800-804-8824
Eric J. Chow
- Recruiting
University of Washington Medical Center - Montlake
Seattle, Washington, 98195
Site Public Contact, 800-804-8824
Eric J. Chow
- Recruiting
Saint Vincent Hospital Cancer Center at Sheboygan
Sheboygan, Wisconsin, 53081
Site Public Contact, 920-433-8889, wi_research_admin@hshs.org
Catherine A. Long
- Recruiting
Sheboygan Physicians Group
Sheboygan, Wisconsin, 53081
Site Public Contact, 920-433-8889, wi_research_admin@hshs.org
Catherine A. Long
- Recruiting
Memorial Hospital East
Shiloh, Illinois, 62269
Site Public Contact, 314-747-9912, dschwab@wustl.edu
Nancy L. Bartlett
- Recruiting
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134
Site Public Contact, 605-312-3320, OncologyClinicalTrialsSF@SanfordHealth.org
Jordan Fritch-Hanson
- Recruiting
Providence Sacred Heart Medical Center and Children's Hospital
Spokane, Washington, 99204
Site Public Contact, 800-228-6618, HopeBeginsHere@providence.org
Judy L. Felgenhauer
- Recruiting
Saint John's Hospital
Springfield, Illinois, 62702
Site Public Contact, 217-525-5666, diana.weyhenmeyer@st-johns.org
Gregory P. Brandt
- Recruiting
Southern Illinois University School of Medicine
Springfield, Illinois, 62702
Site Public Contact, 217-545-7929
Gregory P. Brandt
- Recruiting
Mercy Hospital Springfield
Springfield, Missouri, 65804
Site Public Contact, 417-269-4520
Jay W. Carlson
- Recruiting
CoxHealth South Hospital
Springfield, Missouri, 65807
Site Public Contact, 417-269-4520
Jay W. Carlson
- Recruiting
Mercy Infusion Center - Chippewa
St Louis, Missouri, 63109
Site Public Contact, 888-446-3729
Jay W. Carlson
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Site Public Contact, 800-600-3606, info@siteman.wustl.edu
Nancy L. Bartlett
- Recruiting
Mercy Hospital South
St Louis, Missouri, 63128
Site Public Contact, 314-525-6042, Danielle.Werle@mercy.net
Jay W. Carlson
- Recruiting
Siteman Cancer Center-South County
St Louis, Missouri, 63129
Site Public Contact, 800-600-3606, info@siteman.wustl.edu
Nancy L. Bartlett
- Recruiting
Siteman Cancer Center at Christian Hospital
St Louis, Missouri, 63136
Site Public Contact, 800-600-3606, info@siteman.wustl.edu
Nancy L. Bartlett
- Recruiting
Mercy Hospital Saint Louis
St Louis, Missouri, 63141
Site Public Contact, 314-251-7066
Jay W. Carlson
- Recruiting
Stony Brook University Medical Center
Stony Brook, New York, 11794
Site Public Contact, 800-862-2215
Laura E. Hogan
- Recruiting
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Sturgeon Bay, Wisconsin, 54235-1495
Site Public Contact, 920-433-8889, wi_research_admin@hshs.org
Catherine A. Long
- Recruiting
Madigan Army Medical Center
Tacoma, Washington, 98431
Site Public Contact, 253-968-6144, melissa.a.forouhar.mil@health.mil
Melissa A. Forouhar
- Recruiting
Tampa General Hospital
Tampa, Florida, 33606
Site Public Contact, 813-844-7829, syapchanyk@tgh.org
Andrew J. Galligan
- Active, not recruiting
Saint Joseph's Hospital/Children's Hospital-Tampa
Tampa, Florida, 33607
- Recruiting
Montefiore Medical Center - Moses Campus
The Bronx, New York, 10467
Site Public Contact, 718-379-6866, eskwak@montefiore.org
Alice Lee
- Recruiting
Munson Medical Center
Traverse City, Michigan, 49684
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Recruiting
Banner University Medical Center - Tucson
Tucson, Arizona, 85719
Site Public Contact, UACC-IIT@uacc.arizona.edu
Monica M. Davini
- Suspended
Carle Cancer Center
Urbana, Illinois, 61801
- Recruiting
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, 60555
Site Public Contact, 630-352-5360, Donald.Smith3@nm.org
Shira N. Dinner
- Recruiting
Mercy Hospital Washington
Washington, Missouri, 63090
Site Public Contact, 636-390-1600
Jay W. Carlson
- Recruiting
Children's National Medical Center
Washington D.C., District of Columbia, 20010
Site Public Contact, 202-476-2800, OncCRC_OnCall@childrensnational.org
Jeffrey S. Dome
- Recruiting
UI Health Care Mission Cancer and Blood - Waukee Clinic
Waukee, Iowa, 50263
Site Public Contact, 515-241-3305
Seema Harichand-Herdt
- Recruiting
Mercy Medical Center-West Lakes
West Des Moines, Iowa, 50266
Site Public Contact, 515-241-3305
Richard L. Deming
- Recruiting
The Iowa Clinic PC
West Des Moines, Iowa, 50266
Site Public Contact, 515-875-9815
Seema Harichand-Herdt
- Recruiting
Saint Mary's Medical Center
West Palm Beach, Florida, 33407
Site Public Contact, 561-822-4745
Matthew D. Ramirez
- Recruiting
Christiana Care Health System-Wilmington Hospital
Wilmington, Delaware, 19801
Site Public Contact, 302-623-4450, lbarone@christianacare.org
Gregory A. Masters
- Recruiting
Alfred I duPont Hospital for Children
Wilmington, Delaware, 19803
Site Public Contact, 302-651-5572, Allison.bruce@nemours.org
Vibhuti Agarwal
- Recruiting
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
Site Public Contact, 336-713-6771
Sarah Supples
- Recruiting
University of Michigan Health - West
Wyoming, Michigan, 49519
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Suspended
Rush-Copley Healthcare Center
Yorkville, Illinois, 60560
Canada5 sites, 5 recruiting
- Recruiting
The Montreal Children's Hospital of the MUHC
Montreal, Quebec, H3H 1P3
Site Public Contact, 514-412-4445, info@thechildren.com
Stephanie Mourad
- Recruiting
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, H3T 1C5
Site Public Contact, 514-345-4931, yvan.samson@umontreal.ca
Monia Marzouki
- Recruiting
CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL)
Québec, G1V 4G2
Site Public Contact, 418-525-4444, rechclinique@crchudequebec.ulaval.ca
Bruno Michon
- Recruiting
Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
Sherbrooke, Quebec, J1H 5N4
Site Public Contact, 819-820-6480, crcinformation.chus@ssss.gouv.qc.ca
Josee Brossard
- Recruiting
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9
Site Public Contact, 866-561-1026, ctu_web@cancercare.mb.ca
Stephanie M. Villeneuve
About this study
Official title: Triptorelin and Protection of Ovarian Reserve in Adolescents and Young Adults With Cancer
This phase III trial compares the effect of giving triptorelin vs no triptorelin in preventing ovarian damage in adolescents and young adults (AYAs) with cancer receiving chemotherapy with alkylating agents. Alkylating agents are part of standard chemotherapy, but may cause damage to the ovaries. If the ovaries are not working well or completely shut down, then it will be difficult or impossible to get pregnant in the future. Triptorelin works by blocking certain hormones and causing the ovaries to slow down or pause normal activity. The triptorelin used in this study stays active in the body for 24 weeks or about 6 months after a dose is given. After triptorelin is cleared from the body, the ovaries resume normal activities. Adding triptorelin before the start of chemotherapy treatment may reduce the chances of damage to the ovaries.
Read the detailed description
PRIMARY OBJECTIVES:
- Determine the feasibility of conducting a cross network, multi-site, randomized clinical trial of triptorelin among newly diagnosed adolescent and young adult (AYA) female cancer patients age < 40 years (exclusive of breast cancer).
II. Measure ovarian reserve via anti-Mullerian hormone (AMH) at 2-years post completion of alkylating agent-containing chemotherapy among randomized patients.
SECONDARY OBJECTIVES:
- Collect information on the longitudinal trajectory of change in AMH and other ovarian hormone levels from cancer diagnosis to 2 years post cancer treatment completion among randomized patients.
II. Determine the feasibility of measuring estrogen deprivation symptoms (i.e., hot flashes, sexual dysfunction) menstrual pattern, and quality of life among randomized patients.
EXPLORATORY OBJECTIVE:
- Establish a unique cohort of female AYA patients treated with alkylating agent chemotherapy and randomized to receive or not receive triptorelin, that can be followed long-term to study reproductive health concerns and outcomes as well as genetic risk factors for premature menopause.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients receive triptorelin intramuscularly (IM) up to 14 days prior to or within 7 days after the start of standard chemotherapy. For patients whose chemotherapy exceeds 24 weeks, a second dose of triptorelin may be given 24 weeks after the first dose at the treating physician's discretion. Patients also undergo blood sample collection throughout the study.
ARM B: Patients receive standard chemotherapy. Patients also undergo blood sample collection throughout the study.
After completion of study treatment, patients are followed up at 1 and 2 years.
- Being tested
- Best Practice, Biospecimen Collection, Electronic Health Record Review, Survey Administration, Triptorelin Pamoate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
Also called standard of care, standard therapy
Receive standard chemotherapy
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection
Undergo blood sample collection
Electronic Health Record ReviewOther
Ancillary studies
Survey AdministrationOther
Ancillary studies
Triptorelin PamoateDrug
Also called Decapeptyl, Diphereline, Pamorelin, Trelstar
Given IM
| Study group | Role | What they receive |
|---|---|---|
| Arm A (triptorelin) | Experimental | Patients receive triptorelin IM up to 14 days prior to or within 7 days after the start of standard chemotherapy. For patients whose chemotherapy exceeds 24 weeks, a second dose of triptorelin may be given 24 weeks after the first dose at the treating physician's discretion. Patients also undergo blood sample collection throughout the study. Receives: Procedure: Biospecimen Collection; Other: Electronic Health Record Review; Other: Survey Administration; Drug: Triptorelin Pamoate |
| Arm B (usual care) | Active comparator | Patients receive standard chemotherapy. Patients also undergo blood sample collection throughout the study. Receives: Other: Best Practice; Procedure: Biospecimen Collection; Other: Electronic Health Record Review; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of enrollments of newly diagnosed AYA female cancer patients age < 40 years
Number of enrollments by the end of the DOD funded grant period, and ideally prior to Year 4 to enable greater duration of follow-up time.
Measured: Up to 2 years post-chemotherapy
Accrual rates of newly diagnosed AYA female cancer patients age < 40 years
Accrual rates of newly diagnosed AYA female cancer patients age < 40 years. Over the second half of the funding period, demonstrate a positive trajectory in accrual rates that provides data to inform future funding proposals that would seek to complete the overall larger study within a typical 5-year funding period.
Measured: Up to 2 years post-chemotherapy
Anti-mullerian hormone (AMH) levels
Feasibility of measuring AMH at two years post completion of alkylating agent-containing chemotherapy among randomized patients.
Measured: At 2 years post-chemotherapy
Secondary outcomes (12)
Longitudinal AMH along with other ovarian hormone levels
AMH will be collected at several timepoints from diagnosis to 2 years post cancer treatment completion. These measurements will help inform rates of missingness. Will be used to estimate the longitudinal trajectory of change in these hormones by triptorelin randomization status.
Measured: Up to 2 years post-chemotherapy
Estrogen deprivation symptoms: Hot flashes
Estrogen deprivation symptoms include hot flashes. The Patient-Reported Outcomes version of the Common Terminology for Adverse Events (PRO-CTCAE) will be used to collect information on the frequency and interference of hot flashes.
Measured: Up to 2 years post-chemotherapy
Estrogen deprivation symptoms: Headaches
Estrogen deprivation symptoms include headaches. The Patient-Reported Outcomes version of the Common Terminology for Adverse Events (PRO-CTCAE) will be used to collect information on the frequency and interference of headaches.
Measured: Up to 2 years post-chemotherapy
Estrogen deprivation symptoms: Vaginal/vulvar symptoms
Estrogen deprivation symptoms include vaginal/vulvar symptoms. The Patient-Reported Outcomes version of the Common Terminology for Adverse Events (PRO-CTCAE) will be used to collect information on the frequency and interference of vaginal/vulvar symptoms. The PROMIS Sexual Function and Satisfaction version (v) 2.0 Brief Profile - Female (PROMIS SexFS) will be used to evaluate vaginal and vulvar discomfort, pain, and lubrication.
Measured: Up to 2 years post-chemotherapy
Estrogen deprivation symptoms: Sexual function
Estrogen deprivation symptoms include sexual function. The Patient-Reported Outcomes version of the Common Terminology for Adverse Events (PRO-CTCAE) will be used to collect information on the frequency and interference of sexual function. The PROMIS Sexual Function and Satisfaction version (v) 2.0 Brief Profile - Female (PROMIS SexFS) will be used to evaluate sexual activity, desire, and satisfaction among all participants.
Measured: Up to 2 years post-chemotherapy
Sexual Health
Sexual dysfunction will be assessed using PROMIS SexFS.
Measured: Up to 2 years post-chemotherapy
Menstrual patterns
Menstrual patterns will be assessed using standard items and characterized according to the Staging of Reproductive Aging Workshop criteria.
Measured: Up to 2 years post-chemotherapy
Global health-related quality of life: Anxiety
Global health-related quality of life will be assessed using the PROMIS 29 Profile v2.1, which includes assessment of anxiety. For adolescent participants, the PROMIS Pediatric Profile-25 v2.0 will be used to measure health domains.
Measured: Up to 2 years post-chemotherapy
Global health-related quality of life: Fatigue
Global health-related quality of life will be assessed using the PROMIS 29 Profile v2.1, which includes assessment of fatigue. For adolescent participants, the PROMIS Pediatric Profile-25 v2.0 will be used to measure health domains.
Measured: Up to 2 years post-chemotherapy
Global health-related quality of life: Depression
Global health-related quality of life will be assessed using the PROMIS 29 Profile v2.1, which includes assessment of depression. For adolescent participants, the PROMIS Pediatric Profile-25 v2.0 will be used to measure health domains.
Measured: Up to 2 years post-chemotherapy
Global health-related quality of life: Sleep disturbance
Global health-related quality of life will be assessed using the PROMIS 29 Profile v2.1, which includes assessment of sleep disturbance. For adolescent participants, the PROMIS Pediatric Profile-25 v2.0 will be used to measure health domains, with the addition of the PROMIS Pediatric Sleep Disturbance 4a scale.
Measured: Up to 2 years post-chemotherapy
Global health-related quality of life: Participation in social activities
Global health-related quality of life will be assessed using the PROMIS 29 Profile v2.1, which includes assessment of participation in social activities. For adolescent participants, the PROMIS Pediatric Profile-25 v2.0 will be used to measure health domains.
Measured: Up to 2 years post-chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start27 Feb 2025
- Primary completion30 Oct 2029 (estimated)
- Study completion30 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic and Lymphatic System NeoplasmStudies of the same condition, open and under way.
- More trials run by Children's Oncology GroupThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Oncology Group
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Eric J Chow, Principal investigator, Children's Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06513962
- Sponsor's protocol ID
- ALTE2131
- Other IDs
- NCI-2024-05414, ALTE2131, COG-ALTE2131, ALTE2131, UG1CA189955
- Status last verified
- Aug 2026
- First submitted
- 3 Jul 2024
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No