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AzTrials

Acute LeukemiaNCT00048958

Cytogenetic Studies in Acute Leukemia and Multiple Myeloma

An observational study of Acute Leukemia and Acute Lymphoblastic Leukemia, run by Alliance for Clinical Trials in Oncology at 137 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

Chromosomal analysis or the study of genetic differences in patients previously untreated with AML, ALL, MDS or MM may be helpful in the diagnosis and classification of disease. It may also improve the ability to predict the course of disease and the selection of therapy. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
cytogenetic analysis
How many people
9,000 participants
Where
137 sitesUnited States
Study dates
Jun 1984to Jan 2100
Phase
Observational
Are there results?
Not yet: the study is under way

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patient population from the clinical oncology research community including academic institutions, hospitals and clinics.

  1. Patients from adjuncts are eligible if the Main Member Cytogenetics laboratory has agreed to process samples from that adjunct.
  2. Within one month of registration on CALGB 8461, register onto a CALGB treatment study for previously untreated AML, ALL, MDS, or MM patients.
  3. Simultaneously with registration on CALGB 8461, register patients within the continental United States onto CALGB 9665 (LTB).

Trial locations and contacts

137 sites in 1 country.

137 sites in 1 country

United States137 sites

  • Mission Hospitals - Memorial Campus

    Asheville, North Carolina, 28801

  • Harold Alfond Center for Cancer Care

    Augusta, Maine, 04330

  • Greenebaum Cancer Center at University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • Harry and Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center

    Baltimore, Maryland, 21237

  • CancerCare of Maine at Eastern Maine Medical Center

    Bangor, Maine, 04401

  • Battle Creek Health System Cancer Care Center

    Battle Creek, Michigan, 49017

  • Mountainview Medical

    Berlin Corners, Vermont, 05602

  • Mecosta County Medical Center

    Big Rapids, Michigan, 49307

  • Illinois CancerCare - Bloomington

    Bloomington, Illinois, 61701

  • St. Joseph Medical Center

    Bloomington, Illinois, 61701

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Dana-Farber/Brigham and Women's Cancer Center

    Boston, Massachusetts, 02115

  • Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263-0001

  • Fletcher Allen Health Care - University Health Center Campus

    Burlington, Vermont, 05401

  • Graham Hospital

    Canton, Illinois, 61520

  • Illinois CancerCare - Canton

    Canton, Illinois, 61520

  • Southeast Cancer Center

    Cape Girardeau, Missouri, 63703

  • Illinois CancerCare - Carthage

    Carthage, Illinois, 62321

  • Memorial Hospital

    Carthage, Illinois, 62321

  • Iowa Blood and Cancer Care

    Cedar Rapids, Iowa, 52402

  • St. Luke's Hospital

    Cedar Rapids, Iowa, 52402

  • Mercy Regional Cancer Center at Mercy Medical Center

    Cedar Rapids, Iowa, 52403

  • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

    Chapel Hill, North Carolina, 27599-7295

  • Presbyterian Cancer Center at Presbyterian Hospital

    Charlotte, North Carolina, 28233-3549

  • University of Illinois Cancer Center

    Chicago, Illinois, 60612-7243

  • University of Chicago Cancer Research Center

    Chicago, Illinois, 60637-1470

  • Ellis Fischel Cancer Center at University of Missouri - Columbia

    Columbia, Missouri, 65203

  • Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210-1240

  • Batte Cancer Center at Northeast Medical Center

    Concord, North Carolina, 28025

  • Danville Regional Medical Center

    Danville, Virginia, 24541

  • St. Luke's Hospital Cancer Care Center

    Duluth, Minnesota, 55805

  • Duke Cancer Institute

    Durham, North Carolina, 27710

  • CCOP - Hematology-Oncology Associates of Central New York

    East Syracuse, New York, 13057

  • Union Hospital of Cecil County

    Elkton, Maryland, 21921

  • Eureka Community Hospital

    Eureka, Illinois, 61530

  • Illinois CancerCare - Eureka

    Eureka, Illinois, 61530

  • Evanston Hospital

    Evanston, Illinois, 60201-1781

  • McLeod Regional Medical Center

    Florence, South Carolina, 29501

  • Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital

    Fort Lauderdale, Florida, 33308

  • Fort Wayne Medical Oncology and Hematology

    Fort Wayne, Indiana, 46845

  • Galesburg Clinic, PC

    Galesburg, Illinois, 61401

  • Illinois CancerCare - Galesburg

    Galesburg, Illinois, 61401

  • Charles R. Wood Cancer Center at Glens Falls Hospital

    Glens Falls, New York, 12801

  • Wayne Memorial Hospital, Incorporated

    Goldsboro, North Carolina, 27534

  • Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center

    Grand Island, Nebraska, 68803

  • Butterworth Hospital at Spectrum Health

    Grand Rapids, Michigan, 49503

  • CCOP - Grand Rapids

    Grand Rapids, Michigan, 49503

  • Lacks Cancer Center at Saint Mary's Health Care

    Grand Rapids, Michigan, 49503

  • Leo W. Jenkins Cancer Center at ECU Medical School

    Greenville, North Carolina, 27834

  • Cancer Centers of the Carolinas - Faris Road

    Greenville, South Carolina, 29605

  • Cancer Centers of the Carolinas - Grove Commons

    Greenville, South Carolina, 29605

  • Greenville Hospital Cancer Center

    Greenville, South Carolina, 29605

  • Cancer Centers of the Carolinas - Eastside

    Greenville, South Carolina, 29615

  • CCOP - Greenville

    Greenville, South Carolina, 29615

  • Cancer Centers of the Carolinas - Greer Medical Oncology

    Greer, South Carolina, 29650

  • Illinois CancerCare - Havana

    Havana, Illinois, 62644

  • Mason District Hospital

    Havana, Illinois, 62644

  • Pardee Memorial Hospital

    Hendersonville, North Carolina, 28791

  • Holden Comprehensive Cancer Center at University of Iowa

    Iowa City, Iowa, 52242-1002

  • Goldschmidt Cancer Center

    Jefferson City, Missouri, 65109

  • Ella Milbank Foshay Cancer Center at Jupiter Medical Center

    Jupiter, Florida, 33458

  • Saint Luke's Cancer Institute at Saint Luke's Hospital

    Kansas City, Missouri, 64111

  • North Kansas City Hospital

    Kansas City, Missouri, 64116

  • Heartland Hematology Oncology Associates, Incorporated

    Kansas City, Missouri, 64118

  • Research Medical Center

    Kansas City, Missouri, 64132

  • Illinois CancerCare - Kewanee Clinic

    Kewanee, Illinois, 61443

  • Kinston Medical Specialists

    Kinston, North Carolina, 28501

  • Rebecca and John Moores UCSD Cancer Center

    La Jolla, California, 92093-0658

  • Monter Cancer Center of the North Shore-LIJ Health System

    Lake Success, New York, 11042

  • University Medical Center of Southern Nevada

    Las Vegas, Nevada, 89102

  • CCOP - Nevada Cancer Research Foundation

    Las Vegas, Nevada, 89106

  • Sunrise Hospital and Medical Center

    Las Vegas, Nevada, 89109

  • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756-0002

  • Saint Luke's East - Lee's Summit

    Lee's Summit, Missouri, 64086

  • Tunnell Cancer Center at Beebe Medical Center

    Lewes, Delaware, 19958

  • Parvin Radiation Oncology

    Liberty, Missouri, 64068

  • Illinois CancerCare - Macomb

    Macomb, Illinois, 61455

  • McDonough District Hospital

    Macomb, Illinois, 61455

  • CCOP - North Shore University Hospital

    Manhasset, New York, 11030

  • Don Monti Comprehensive Cancer Center at North Shore University Hospital

    Manhasset, New York, 11030

  • CCOP - Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • Veterans Affairs Medical Center - Minneapolis

    Minneapolis, Minnesota, 55417

  • Masonic Cancer Center at University of Minnesota

    Minneapolis, Minnesota, 55455

  • Illinois CancerCare - Monmouth

    Monmouth, Illinois, 61462

  • OSF Holy Family Medical Center

    Monmouth, Illinois, 61462

  • Camino Medical Group - Treatment Center

    Mountain View, California, 94040

  • Mercy General Health Partners

    Muskegon, Michigan, 49444

  • Long Island Jewish Medical Center

    New Hyde Park, New York, 11040

  • New York Weill Cornell Cancer Center at Cornell University

    New York, New York, 10021

  • Mount Sinai Medical Center

    New York, New York, 10029

  • CCOP - Christiana Care Health Services

    Newark, Delaware, 19713

  • BroMenn Regional Medical Center

    Normal, Illinois, 61761

  • Community Cancer Center

    Normal, Illinois, 61761

  • Illinois CancerCare - Community Cancer Center

    Normal, Illinois, 61761

  • Callahan Cancer Center at Great Plains Regional Medical Center

    North Platte, Nebraska, 69103

  • Oklahoma University Cancer Institute

    Oklahoma City, Oklahoma, 73104

  • UNMC Eppley Cancer Center at the University of Nebraska Medical Center

    Omaha, Nebraska, 68198-6805

  • Community Hospital of Ottawa

    Ottawa, Illinois, 61350

  • Oncology Hematology Associates of Central Illinois, PC - Ottawa

    Ottawa, Illinois, 61350

  • Menorah Medical Center

    Overland Park, Kansas, 66209

  • Saint Luke's Hospital - South

    Overland Park, Kansas, 66213

  • Cancer Treatment Center at Pekin Hospital

    Pekin, Illinois, 61554

  • Illinois CancerCare - Pekin

    Pekin, Illinois, 61603

  • Proctor Hospital

    Peoria, Illinois, 61614

  • CCOP - Illinois Oncology Research Association

    Peoria, Illinois, 61615

  • Oncology Hematology Associates of Central Illinois, PC - Peoria

    Peoria, Illinois, 61615

  • Methodist Medical Center of Illinois

    Peoria, Illinois, 61636

  • OSF St. Francis Medical Center

    Peoria, Illinois, 61637

  • Illinois CancerCare - Peru

    Peru, Illinois, 61354

  • Illinois Valley Community Hospital

    Peru, Illinois, 61354

  • Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital

    Pittsburgh, Pennsylvania, 15224-1791

  • CCOP - Kansas City

    Prairie Village, Kansas, 66208

  • Illinois CancerCare - Princeton

    Princeton, Illinois, 61356

  • Perry Memorial Hospital

    Princeton, Illinois, 61356

  • Rhode Island Hospital Comprehensive Cancer Center

    Providence, Rhode Island, 02903

  • Miriam Hospital

    Providence, Rhode Island, 02906

  • Spectrum Health Reed City Hospital

    Reed City, Michigan, 49677

  • Virginia Commonwealth University Massey Cancer Center

    Richmond, Virginia, 23298-0037

  • Heartland Regional Medical Center

    Saint Joseph, Missouri, 64506

  • Saint Joseph Oncology, Incorporated

    Saint Joseph, Missouri, 64507

  • Kaiser Permanente Medical Office -Vandever Medical Office

    San Diego, California, 92108

  • Naval Medical Center - San Diego

    San Diego, California, 92134

  • UCSF Helen Diller Family Comprehensive Cancer Center

    San Francisco, California, 94115

  • Maine Center for Cancer Medicine and Blood Disorders - Scarborough

    Scarborough, Maine, 04074

  • Cancer Centers of the Carolinas - Seneca

    Seneca, South Carolina, 29672

  • Cancer Centers of the Carolinas - Spartanburg

    Spartanburg, South Carolina, 29307

  • Illinois CancerCare - Spring Valley

    Spring Valley, Illinois, 61362

  • Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

    St Louis, Missouri, 63110

  • Missouri Baptist Cancer Center

    St Louis, Missouri, 63131

  • SUNY Upstate Medical University Hospital

    Syracuse, New York, 13210

  • Munson Medical Center

    Traverse City, Michigan, 49684

  • Cancer Institute of New Jersey at Cooper - Voorhees

    Voorhees Township, New Jersey, 08043

  • Lombardi Comprehensive Cancer Center at Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007

  • Washington Cancer Institute at Washington Hospital Center

    Washington D.C., District of Columbia, 20010

  • Forsyth Regional Cancer Center at Forsyth Medical Center

    Winston-Salem, North Carolina, 27103

  • Wake Forest University Comprehensive Cancer Center

    Winston-Salem, North Carolina, 27157-1096

Other trials in United States

About this study

Official title: Cytogenetic Studies in Acute Leukemia and Multiple Myeloma: Companion to CALGB Treatment Studies For Previously Untreated Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL), Myelodysplastic Syndrome (MDS) or Multiple Myeloma (MM) Patients

Chromosomal analysis or the study of genetic differences in patients previously untreated with AML, ALL, MDS or MM may be helpful in the diagnosis and classification of disease. It may also improve the ability to predict the course of disease and the selection of therapy. Institutions must have either an Alliance-approved cytogeneticist or an agreement from an Alliance-approved main member cytogenetics laboratory to enroll a patient on CALGB 8461. The Alliance Approved Institutional Cytogeneticists list is posted on the Alliance for Clinical Trials in Oncology website.

Being tested
cytogenetic analysis
Medical subject headings
Precursor Cell Lymphoblastic Leukemia-Lymphoma, Myelodysplastic Syndromes, Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cytogenetic analysisGenetic

Study groups in NCT00048958
Study groupRoleWhat they receive
No treatmentSamples as defined per the protocol for previously untreated patients with AML, ALL, MDS or MM will be submitted for analysis and within one month patients are required to register onto a CALGB treatment study.
Receives: Genetic: cytogenetic analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Determine the incidence of specific less common primary as well as common secondary chromosome abnormalities in adult AML, ALL, MDS and MM

    Measured: Up to 10 years

  2. Correlate specific (normal or various primary and secondary chromosomal abnormalities) with clinical and laboratory parameters

    Measured: Up to 10 years

  3. Correlate specific karyotype groups with response rates, response duration, survival and cure in patients treated with various induction and post-induction regimens

    Measured: Up to 10 years

  4. Correlate specific karyotype groups with selected molecular abnormalities as studied in CALGB leukemia protocols

    Measured: Up to 10 years

  5. To correlate specific karyotype groups with multidrug resistance data

    Measured: Up to 10 years

  6. To correlate specific karyotype groups with epidemiologic data (toxic exposure and family history)

    Measured: Up to 10 years

  7. To determine karyotype changes at relapse and the influence of the type of change (or no change) in karyotype at relapse on subsequent clinical course

    Measured: up to 10 yeras

  8. To identify new chromosome abnormalities important in leukemogenesis

    Measured: Up to 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startJun 1984
  3. Primary completionJan 2100 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
9,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00048958
Sponsor's protocol ID
CALGB-8461
Other IDs
NCI-2009-00494, CDR0000256897, 3U24CA114725-09S1
Status last verified
Jul 2024
First submitted
12 Nov 2002
Last updated
31 Jul 2024
Results posted
No
Data monitoring committee
No

Publications

  • Marcucci G, Mrozek K, Ruppert AS, Maharry K, Kolitz JE, Moore JO, Mayer RJ, Pettenati MJ, Powell BL, Edwards CG, Sterling LJ, Vardiman JW, Schiffer CA, Carroll AJ, Larson RA, Bloomfield CD. Prognostic factors and outcome of core binding factor acute myeloid leukemia patients with t(8;21) differ from those of patients with inv(16): a Cancer and Leukemia Group B study. J Clin Oncol. 2005 Aug 20;23(24):5705-17. doi: 10.1200/JCO.2005.15.610.

    PubMed 16110030

  • Mrozek K, Carroll AJ, Maharry K, et al.: Central review of cytogenetics is essential for cooperative group clinical and correlative studies of acute leukemia: The Cancer and Leukemia Group B (CALGB) 8461 experience. [Abstract] Blood 104 (11): A-1081, 2004.

  • Sekeres MA, Peterson B, Dodge RK, Mayer RJ, Moore JO, Lee EJ, Kolitz J, Baer MR, Schiffer CA, Carroll AJ, Vardiman JW, Davey FR, Bloomfield CD, Larson RA, Stone RM; Cancer and Leukemia Group B. Differences in prognostic factors and outcomes in African Americans and whites with acute myeloid leukemia. Blood. 2004 Jun 1;103(11):4036-42. doi: 10.1182/blood-2003-09-3118. Epub 2004 Feb 19.

    PubMed 14976037

  • Baldus CD, Tanner SM, Ruppert AS, Whitman SP, Archer KJ, Marcucci G, Caligiuri MA, Carroll AJ, Vardiman JW, Powell BL, Allen SL, Moore JO, Larson RA, Kolitz JE, de la Chapelle A, Bloomfield CD. BAALC expression predicts clinical outcome of de novo acute myeloid leukemia patients with normal cytogenetics: a Cancer and Leukemia Group B Study. Blood. 2003 Sep 1;102(5):1613-8. doi: 10.1182/blood-2003-02-0359. Epub 2003 May 15.

    PubMed 12750167

  • Heinonen K, Rao PN, Slack JL, Cruz J, Bloomfield CD, Mrozek K. Isochromosome 12p in two cases of acute myeloid leukaemia without evidence of germ cell tumour. Br J Haematol. 1996 Jun;93(3):677-80. doi: 10.1046/j.1365-2141.1996.d01-1687.x.

    PubMed 8652392

  • Cancer and Leukemia Group B 8461; Farag SS, Archer KJ, Mrozek K, Ruppert AS, Carroll AJ, Vardiman JW, Pettenati MJ, Baer MR, Qumsiyeh MB, Koduru PR, Ning Y, Mayer RJ, Stone RM, Larson RA, Bloomfield CD. Pretreatment cytogenetics add to other prognostic factors predicting complete remission and long-term outcome in patients 60 years of age or older with acute myeloid leukemia: results from Cancer and Leukemia Group B 8461. Blood. 2006 Jul 1;108(1):63-73. doi: 10.1182/blood-2005-11-4354. Epub 2006 Mar 7.

    PubMed 16522815

  • Farag SS, Ruppert AS, Mrozek K, Mayer RJ, Stone RM, Carroll AJ, Powell BL, Moore JO, Pettenati MJ, Koduru PR, Stamberg J, Baer MR, Block AW, Vardiman JW, Kolitz JE, Schiffer CA, Larson RA, Bloomfield CD. Outcome of induction and postremission therapy in younger adults with acute myeloid leukemia with normal karyotype: a cancer and leukemia group B study. J Clin Oncol. 2005 Jan 20;23(3):482-93. doi: 10.1200/JCO.2005.06.090. Epub 2004 Nov 8.

    PubMed 15534356

  • Bloomfield CD, Ruppert AS, Mrozek K, Kolitz JE, Moore JO, Mayer RJ, Edwards CG, Sterling LJ, Vardiman JW, Carroll AJ, Pettenati MJ, Stamberg J, Byrd JC, Marcucci G, Larson RA; Cancer and Leukemia Group B (CALGB) Study 8461. Core binding factor acute myeloid leukemia. Cancer and Leukemia Group B (CALGB) Study 8461. Ann Hematol. 2004;83 Suppl 1:S84-5. doi: 10.1007/s00277-004-0850-2. No abstract available.

    PubMed 15124687

  • Blum W, Mrozek K, Ruppert AS, et al.: Early allogeneic transplantation for adults with de novo acute myeloid leukemia presenting with t(6;11)(q27;q23): results from CALGB 8461. [Abstract] J Clin Oncol 22 (Suppl 14): A-6543, 568s, 2004.

  • Blum W, Mrozek K, Ruppert AS, Carroll AJ, Rao KW, Pettenati MJ, Anastasi J, Larson RA, Bloomfield CD. Adult de novo acute myeloid leukemia with t(6;11)(q27;q23): results from Cancer and Leukemia Group B Study 8461 and review of the literature. Cancer. 2004 Sep 15;101(6):1420-7. doi: 10.1002/cncr.20489.

    PubMed 15368330

  • Byrd JC, Ruppert AS, Mrozek K, Carroll AJ, Edwards CG, Arthur DC, Pettenati MJ, Stamberg J, Koduru PR, Moore JO, Mayer RJ, Davey FR, Larson RA, Bloomfield CD. Repetitive cycles of high-dose cytarabine benefit patients with acute myeloid leukemia and inv(16)(p13q22) or t(16;16)(p13;q22): results from CALGB 8461. J Clin Oncol. 2004 Mar 15;22(6):1087-94. doi: 10.1200/JCO.2004.07.012.

    PubMed 15020610

  • Farag SS, Archer KJ, Mrózek K, et al.: Pre-treatment cytogenetics predict complete remission and long-term outcome in patients (Pts) ≥60 years with acute myeloid leukemia (AML): results from Cancer and Leukemia Group B (CALGB) 8461. [Abstract] Blood 104 (11): A-568, 2004.

  • Marcucci G, Mrózek, K, Ruppert AS, et al.: t(8;21) Acute myeloid leukemia (AML) differs from inv(16) AML in pretreatment characteristics, outcome and prognostic factors predicting outcome: a Cancer and Leukemia Group B (CALGB) Study. [Abstract] Blood 104 (11): A-2017, 2004.

  • Marcucci G, Mrozek K, Ruppert AS, Archer KJ, Pettenati MJ, Heerema NA, Carroll AJ, Koduru PR, Kolitz JE, Sterling LJ, Edwards CG, Anastasi J, Larson RA, Bloomfield CD. Abnormal cytogenetics at date of morphologic complete remission predicts short overall and disease-free survival, and higher relapse rate in adult acute myeloid leukemia: results from cancer and leukemia group B study 8461. J Clin Oncol. 2004 Jun 15;22(12):2410-8. doi: 10.1200/JCO.2004.03.023.

    PubMed 15197203

  • Slovak ML, Bloomfield CD, Gundacker H, et al.: Acute myeloid leukemia (AML) with t(6;9)(p23;q34) defines a very poor risk leukemia subgroup with distinguishing clinicopathological features: a United States (US) Cytogenetics Intergroup Study of 62 AML and MDS cases. [Abstract] Blood 104 (11): A-567, 2004.

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Leukemia and Acute Lymphoblastic Leukemia, run by Alliance for Clinical Trials in Oncology at 137 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 137 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determine the incidence of specific less common primary as well as common secondary chromosome abnormalities in adult AML, ALL, MDS and MM (time frame: Up to 10 years). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00048958, which also lists 50 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2024.

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