AzTrials
AzTrials

LeukemiaPhase 3NCT00049517

Combination Chemotherapy With or Without Monoclonal Antibody Therapy in Treating Patients With AML Leukemia

A Phase 3 study testing sargramostim, busulfan and cyclophosphamide in people with Leukemia, run by Eastern Cooperative Oncology Group at 99 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

RATIONALE: Giving combination chemotherapy before a stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the transplanted stem cells. Read more about this study

Who is it for?
Ages 16 to 60 years
Conditions the study is for
Leukemia
What is being tested?
sargramostim, busulfan and cyclophosphamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
657 participants
Where
99 sitesin 2 countries
Study dates
19 Dec 2002to Dec 2019
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 16 to 60 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Morphologically confirmed acute myeloid leukemia (AML) (greater than 20% blasts in the peripheral blood or marrow) meeting any of the following criteria:
  • Recurrent cytogenetic translocations
  • t(8;21)(q22;q22)
  • Bone marrow eosinophil abnormalities
  • inv(16)(p13;q22)
  • t(16;16)(p13;q22)
Show all 30Show fewer
  • 11q23 abnormalities
  • Multilineage dysplasia without presence of myelodysplastic syndromes (MDS)
  • Minimally differentiated AML
  • AML without maturation
  • AML with maturation
  • AML not otherwise categorized
  • Acute myelomonocytic leukemia
  • Acute monocytic leukemia
  • Acute erythroid leukemia
  • Acute megakaryocytic leukemia
  • Acute basophilic leukemia
  • Patients undergoing allogeneic transplantation must have a sibling donor match defined as human leukocyte antigen (HLA) match or haplotype match with one locus mismatch on other haplotype
  • Age 16 to 60
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-4
  • Aspartate aminotransferase (AST) less than 4 times upper limit of normal (ULN)
  • Alkaline phosphatase less than 4 times ULN
  • Creatinine no greater than 2.0 mg/dL
  • Creatinine clearance at least 50 mL/min
  • Left ventricular ejection fraction (LVEF) at least 45% by post-induction multigated acquisition (MUGA) scan
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • HIV negative
  • Prior hydroxyurea allowed
  • Prior corticosteroids allowed

Who cannot join

  • Recurrent cytogenetic translocations
  • Acute promyelocytic leukemia (PML) with t(15;17)(q22;q21)
  • Variant acute PML with t(v;17)
  • Multilineage dysplasia with prior MDS
  • Acute panmyelosis with myelofibrosis
  • Blastic transformation of chronic myelogenous leukemia
Show all 13Show fewer
  • Secondary AML (chemotherapy-induced or evolved from MDS)
  • Pregnant or nursing
  • Bilirubin greater than 2.0 mg/dL (unless related to Gilbert's syndrome or hemolysis)
  • Significant cardiac disease requiring active therapy (e.g., digoxin, diuretics, antiarrhythmics, or antianginal medications)
  • Prior biologic therapy
  • Prior cytotoxic chemotherapy for any malignancy
  • Prior radiotherapy for any malignancy

Trial locations and contacts

99 sites in 2 countries.

99 sites in 2 countries

United States98 sites

  • Winship Cancer Institute of Emory University

    Atlanta, Georgia, 30322

  • Aurora Presbyterian Hospital

    Aurora, Colorado, 80012

  • MeritCare Bemidji

    Bemidji, Minnesota, 56601

  • CCOP - Montana Cancer Consortium

    Billings, Montana, 59101

  • Hematology-Oncology Centers of the Northern Rockies - Billings

    Billings, Montana, 59101

  • Northern Rockies Radiation Oncology Center

    Billings, Montana, 59101

  • St. Vincent Healthcare Cancer Care Services

    Billings, Montana, 59101

  • Billings Clinic - Downtown

    Billings, Montana, 59107-7000

  • Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham

    Birmingham, Alabama, 35294

  • Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - West

    Boca Raton, Florida, 33428

  • Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - Main Campus

    Boca Raton, Florida, 33486

  • Tufts-NEMC Cancer Center

    Boston, Massachusetts, 02111

  • Bozeman Deaconess Cancer Center

    Bozeman, Montana, 59715

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • St. James Healthcare Cancer Care

    Butte, Montana, 59701

  • Mercy Cancer Center at Mercy Medical Center

    Canton, Ohio, 44708

  • Aultman Cancer Center at Aultman Hospital

    Canton, Ohio, 44710-1799

  • Robert H. Lurie Comprehensive Cancer Center at Northwestern University

    Chicago, Illinois, 60611-3013

  • Hematology and Oncology Associates

    Chicago, Illinois, 60611

  • Jewish Hospital Cancer Center

    Cincinnati, Ohio, 45236

  • Penrose Cancer Center at Penrose Hospital

    Colorado Springs, Colorado, 80933

  • Mercy and Unity Cancer Center at Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Geisinger Cancer Institute at Geisinger Health

    Danville, Pennsylvania, 17822-0001

  • St. Anthony Central Hospital

    Denver, Colorado, 80204

  • Porter Adventist Hospital

    Denver, Colorado, 80210

  • Presbyterian - St. Luke's Medical Center

    Denver, Colorado, 80218

  • St. Joseph Hospital

    Denver, Colorado, 80218

  • Rose Medical Center

    Denver, Colorado, 80220

  • CCOP - Colorado Cancer Research Program

    Denver, Colorado, 80224-2522

  • Marshfield Clinic Cancer Care at Regional Cancer Center

    Eau Claire, Wisconsin, 54701

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

  • Swedish Medical Center

    Englewood, Colorado, 80110

  • Evanston Northwestern Healthcare - Evanston Hospital

    Evanston, Illinois, 60201-1781

  • CCOP - MeritCare Hospital

    Fargo, North Dakota, 58122

  • MeritCare Broadway

    Fargo, North Dakota, 58122

  • Fort Wayne Medical Oncology and Hematology

    Fort Wayne, Indiana, 46815

  • Mercy and Unity Cancer Center at Unity Hospital

    Fridley, Minnesota, 55432

  • University of Florida Shands Cancer Center

    Gainesville, Florida, 32610-0232

  • St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center

    Grand Junction, Colorado, 81502

  • Great Falls Clinic - Main Facility

    Great Falls, Montana, 59405

  • Great Falls Clinic

    Great Falls, Montana, 59405

  • North Colorado Medical Center

    Greeley, Colorado, 80631

  • St. Peter's Hospital

    Helena, Montana, 59601

  • Penn State Cancer Institute at Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850

  • Indiana University Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202-5289

  • Midwest Center for Hematology/Oncology

    Joliet, Illinois, 60432

  • Joliet Oncology-Hematology Associates, Limited - West

    Joliet, Illinois, 60435

  • Borgess Medical Center

    Kalamazoo, Michigan, 49001

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007-3731

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

  • Glacier Oncology, PLLC

    Kalispell, Montana, 59901

  • Kalispell Medical Oncology at KRMC

    Kalispell, Montana, 59901

  • Kalispell Regional Medical Center

    Kalispell, Montana, 59901

  • Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center

    La Crosse, Wisconsin, 54601

  • North Shore Oncology and Hematology Associates, Limited - Libertyville

    Libertyville, Illinois, 60048

  • St. Rita's Medical Center

    Lima, Ohio, 45801

  • Sky Ridge Medical Center

    Lone Tree, Colorado, 80124

  • Hope Cancer Care Center at Longmont United Hospital

    Longmont, Colorado, 80502

  • McKee Medical Center

    Loveland, Colorado, 80539

  • University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

    Madison, Wisconsin, 53792-6164

  • Minnesota Oncology Hematology, PA - Maplewood

    Maplewood, Minnesota, 55109

  • Marshfield Clinic - Marshfield Center

    Marshfield, Wisconsin, 54449

  • Saint Joseph's Hospital

    Marshfield, Wisconsin, 54449

  • University of Miami Sylvester Comprehensive Cancer Center - Miami

    Miami, Florida, 33136

  • Virginia Piper Cancer Institute at Abbott - Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Community Medical Center

    Missoula, Montana, 59801

  • Guardian Oncology and Center for Wellness

    Missoula, Montana, 59804

  • Montana Cancer Specialists at Montana Cancer Center

    Missoula, Montana, 59807-7877

  • Montana Cancer Center at St. Patrick Hospital and Health Sciences Center

    Missoula, Montana, 59807

  • La Grange Oncology Associates - Geneva

    Naperville, Illinois, 60563

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232-6838

  • NYU Cancer Institute at New York University Medical Center

    New York, New York, 10016

  • Cancer Care and Hematology Specialists of Chicagoland - Niles

    Niles, Illinois, 60714

  • Advocate Lutheran General Cancer Care Center

    Park Ridge, Illinois, 60068-1174

  • Abramson Cancer Center of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104-4283

  • Fox Chase Cancer Center - Philadelphia

    Philadelphia, Pennsylvania, 19111-2497

  • UPMC Cancer Centers

    Pittsburgh, Pennsylvania, 15232

  • St. Mary - Corwin Regional Medical Center

    Pueblo, Colorado, 81004

  • Ministry Medical Group at Saint Mary's Hospital

    Rhinelander, Wisconsin, 54501

  • Virginia Commonwealth University Massey Cancer Center

    Richmond, Virginia, 23298-0037

  • Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center

    Robbinsdale, Minnesota, 55422-2900

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905

  • CCOP - Metro-Minnesota

    Saint Louis Park, Minnesota, 55416

  • Park Nicollet Cancer Center

    Saint Louis Park, Minnesota, 55416

  • United Hospital

    Saint Paul, Minnesota, 55102

  • Mayo Clinic Scottsdale

    Scottsdale, Arizona, 85259-5499

  • Welch Cancer Center at Sheridan Memorial Hospital

    Sheridan, Wyoming, 82801

  • Hematology Oncology Associates - Skokie

    Skokie, Illinois, 60076

  • Geisinger Medical Group - Scenery Park

    State College, Pennsylvania, 16801

  • Albert Einstein Cancer Center at Albert Einstein College of Medicine

    The Bronx, New York, 10461

  • North Suburban Medical Center

    Thornton, Colorado, 80229

  • Carle Cancer Center at Carle Foundation Hospital

    Urbana, Illinois, 61801

  • CCOP - Carle Cancer Center

    Urbana, Illinois, 61801

  • Ridgeview Medical Center

    Waconia, Minnesota, 55387

  • Marshfield Clinic - Weston Center

    Weston, Wisconsin, 54476

  • Exempla Lutheran Medical Center

    Wheat Ridge, Colorado, 80033

  • Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center

    Wilkes-Barre, Pennsylvania, 18711

  • Minnesota Oncology Hematology, PA - Woodbury

    Woodbury, Minnesota, 55125

Other trials in United States

Israel1 site

  • Rambam Medical Center

    Haifa, 31096

Other trials in Israel

About this study

Official title: A Phase III Trial in Adult Acute Myeloid Leukemia: Daunorubicin Dose-Intensification Prior to Risk-Allocated Autologous Stem Cell Transplantation

RATIONALE: Giving combination chemotherapy before a stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the transplanted stem cells. When the healthy stem cells are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. If the patient's stem cells are to be transplanted, the patient is also treated with a monoclonal antibody, such as gemtuzumab ozogamicin, to kill any remaining cancer cells or deliver cancer-killing substances to them without harming normal cells. It is not yet known whether combination chemotherapy is more effective with or without gemtuzumab ozogamicin followed by stem cell transplant in treating acute myeloid leukemia.

PURPOSE: This randomized phase III trial is studying combination chemotherapy, gemtuzumab ozogamicin, and stem cell transplant to see how well they work compared to combination chemotherapy and peripheral stem cell transplant alone in treating patients with acute myeloid leukemia.

Read the detailed description

OBJECTIVES:

  • To compare the overall survival (OS) between two induction regimens (standard versus dose intense daunorubicin and cytarabine) in patients with de novo AML.
  • To compare disease-free survival (DFS) between two consolidation regimens.
  • To compare overall survival between two consolidation regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to induction therapy (standard-dose daunorubicin vs high-dose daunorubicin).

  • Induction therapy: Patients are randomized to 1 of 2 induction arms.
  • Standard: Patients receive standard-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7.
  • High dose: Patients receive high-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine as in arm I.

Patients in both arms may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course. The second course is administered as in arm I to all patients. Patients who don't achieve CR after 2 courses of induction therapy are removed from study.

Patients who achieve CR after induction therapy proceed to post-remission therapy with EITHER allogeneic transplantation only (on or off study) OR consolidation therapy and autologous transplantation (on study), according to risk status and donor status.

Patients who are considered at intermediate or high risk for relapse (unfavorable cytogenetics/high WBC) and have a suitable related donor undergo an allogeneic transplantation. Patients with intermediate-risk cytogenetics, WBC no greater than 100,000/mm^3, and appropriate donors have the option of undergoing allogeneic transplantation.

  • Allogeneic transplantation: Within 1-3 months after recovery from induction therapy, patients receive busulfan IV every 6 hours on days -7 to -4 and cyclophosphamide IV over 4 hours on days -3 and -2. Allogeneic bone marrow or peripheral blood stem cells (PBSCs) are infused on day 0. Patients receive graft-vs-host disease (GVHD) prophylaxis comprising cyclosporine IV over 1-4 hours beginning on day -1 and then orally (when tolerated) twice daily until day 180. Alternatively, patients may receive tacrolimus IV over 24 hours beginning on day -1 and then orally twice daily until day 180. Patients also receive methotrexate IV on days 1, 3, 6, and 11.

Patients who do not meet the criteria for allogeneic transplantation (i.e., are favorable risk or do not have a matching related donor) or who opt not to undergo allogeneic transplantation proceed to consolidation therapy followed by randomization to 1 of 2 autologous transplantation arms.

  • Consolidation therapy: Beginning 2-8 weeks after recovery from induction therapy, patients receive high-dose cytarabine IV over 3 hours every 12 hours on days 1, 3, and 5. A second course is administered 3 weeks after blood recovery. Patients receive filgrastim (G-CSF) subcutaneously (SC) daily for 4 days and then autologous PBSCs are harvested by leukapheresis.
  • Autologous stem cell transplantation: Patients are randomized to 1 of 2 autologous transplantation arms.
  • Arm I: Within 1 month after PBSC collection, patients receive conditioning comprising busulfan IV every 6 hours on days -7 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2. Patients then undergo autologous PBSC transplantation on day 0. Patients receive sargramostim (GM-CSF) or G-CSF IV or SC beginning on day 0 and continuing until blood counts recover.
  • Arm II (closed to accrual as of 10/4/2007): Within 2-4 weeks after PBSC collection, patients receive gemtuzumab ozogamicin IV over 2 hours on day 1 and GM-CSF SC or IV beginning on day 10 and continuing until blood counts recover. Within 2-3 weeks after blood count recovery, patients receive conditioning and undergo autologous PBSC transplantation as in arm I.

Patients are followed monthly for 1 year, every 2 months for 1 year, and then every 3 months for up to 7 years.

ACTUAL ACCRUAL: A total of 657 patients were accrued for this study.

Conditions
Leukemia
Being tested
sargramostim, busulfan, cyclophosphamide, cytarabine, gemtuzumab ozogamicin (GO)
Keywords
acute myeloid leukemia, autologous transplantation, gemtuzumab ozogamicin
Medical subject headings
Leukemia, Leukemia, Myeloid, Acute

What participants receive

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

  • sargramostimBiological

    Also called Leukine

    Given IV or as an injection

  • busulfanDrug

    Also called Myleran

    Given IV

  • cyclophosphamideDrug

    Also called Endoxan, Cytoxan, Neosar, Procytox

    Given IV

  • cytarabineDrug

    Also called cytosine arabinoside

    Given as a continuous infusion

  • gemtuzumab ozogamicin (GO)Drug

    Also called Mylotarg

    Given IV

  • DaunorubicinDrug

    Also called daunomycin, daunomycin cerubidine

    Given intravenously daily for 3 days at a dose of either 45 or 90 mg/m2.

  • Autologous HCTProcedure or surgery

    Also called Autologous hematopoietic cell transplantation

    Autologous hematopoietic cell transplantation

  • Allogeneic HCTProcedure or surgery

    Also called Allogeneic hematopoietic cell transplantation

    Allogeneic hematopoietic cell transplantation

Study groups in NCT00049517
Study groupRoleWhat they receive
Standard Daunorubicin Then Autologous HCTExperimentalInduction: Patients receive standard-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course. Consolidation/Transplant: Before initiating consolidation therapy, patients with CR were randomized to a standard or an investigational arm. All patients received 2 cycles of high-dose cytarabine therapy (3 g/m2 given IV over a 3-hour period every 12 hours every other day for a total of 6 doses), followed by sargramostim 250 μg/m2 until recovery of blood counts. The patients undergoing autologous hematopoietic cell transplantation (HCT) received intravenous busulfan 0.8 mg/kg every 6 hours for 16 doses (without pharmacokinetic sampling) followed by intravenous cyclophosphamide 60 mg/kg daily for 2 days.
Receives: Biological: sargramostim; Drug: busulfan; Drug: cyclophosphamide; Drug: cytarabine; Drug: Daunorubicin; Procedure: Autologous HCT
High-dose Daunorubicin Then Autologous HCTExperimentalInduction: Patients receive high-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course. Consolidation/Transplant: Before initiating consolidation therapy, patients with CR were randomized to a standard or an investigational arm. All patients received 2 cycles of high-dose cytarabine therapy (3 g/m2 given IV over a 3-hour period every 12 hours every other day for a total of 6 doses), followed by sargramostim 250 μg/m2 until recovery of blood counts. The patients undergoing autologous hematopoietic cell transplantation (HCT) received intravenous busulfan 0.8 mg/kg every 6 hours for 16 doses (without pharmacokinetic sampling) followed by intravenous cyclophosphamide 60 mg/kg daily for 2 days.
Receives: Biological: sargramostim; Drug: busulfan; Drug: cyclophosphamide; Drug: cytarabine; Drug: Daunorubicin; Procedure: Autologous HCT
Standard Daunorubicin Then GO/Autologous HCTExperimentalInduction: Patients receive standard-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course. Consolidation/Transplant: Before initiating consolidation therapy, patients with CR were randomized to a standard or an investigational arm. All patients received 2 cycles of high-dose cytarabine therapy (3 g/m2 given IV over a 3-hour period every 12 hours every other day for a total of 6 doses), followed by sargramostim 250 μg/m2 until recovery of blood counts. patients randomized to the investigational arm received a single dose of Gemtuzumab ozogamicin (GO) at 6 mg/m2 followed by sargramostim 250 μ/m2 until recovery of counts. The patients undergoing autologous HCT received intravenous busulfan 0.8 mg/kg every 6 hours for 16 doses followed by intravenous cyclophosphamide 60 mg/kg daily for 2 days.
Receives: Biological: sargramostim; Drug: busulfan; Drug: cyclophosphamide; Drug: cytarabine; Drug: gemtuzumab ozogamicin (GO); Drug: Daunorubicin; Procedure: Autologous HCT
High-dose Daunorubicin Then GO/Autologous HCTExperimentalInduction: Patients receive high-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course. Consolidation/Transplant: Before initiating consolidation therapy, patients with CR were randomized to a standard or an investigational arm. All patients received 2 cycles of high-dose cytarabine therapy (3 g/m2 given IV over a 3-hour period every 12 hours every other day for a total of 6 doses), followed by sargramostim 250 μg/m2 until recovery of blood counts. patients randomized to the investigational arm received a single dose of Gemtuzumab ozogamicin (GO) at 6 mg/m2 followed by sargramostim 250 μ/m2 until recovery of counts. The patients undergoing autologous HCT received intravenous busulfan 0.8 mg/kg every 6 hours for 16 doses followed by intravenous cyclophosphamide 60 mg/kg daily for 2 days.
Receives: Biological: sargramostim; Drug: busulfan; Drug: cyclophosphamide; Drug: cytarabine; Drug: gemtuzumab ozogamicin (GO); Drug: Daunorubicin; Procedure: Autologous HCT
Standard Daunorubicin Then Allogeneic HCT or no ConsolidationActive comparatorInduction: Patients receive standard-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course. Consolidation/Transplant: Patients without CR did not receive any consolidation treatment. Patients in CR with an unfavorable cytogenetic profile or an initial white blood cell count > 100,000/μL were to proceed to allogeneic HCT if they had a suitable human leukocyte antigen (HLA)-matched sibling donor available.
Receives: Drug: cytarabine; Drug: Daunorubicin; Procedure: Allogeneic HCT
High-dose Daunorubicin Then Allogeneic HCT or no ConsolidationExperimentalInduction: Patients receive high-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course. Consolidation/Transplant: Patients without CR did not receive any consolidation treatment. Patients in CR with an unfavorable cytogenetic profile or an initial white blood cell count > 100,000/μL were to proceed to allogeneic HCT if they had a suitable human leukocyte antigen (HLA)-matched sibling donor available.
Receives: Drug: cytarabine; Drug: Daunorubicin; Procedure: Allogeneic HCT

What is being measured

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

  1. Overall Survival (Induction Phase)

    Overall survival is defined as the time from randomization in the induction phase to death.

    Measured: Assessed during the first 4 months, then at least every three months for 2 years. then every six months until 5 years after study entry and every 12 months thereafter.

  2. Disease-free Survival (Consolidation Phase)

    Disease-free survival is defined from the time of the confirmation of a complete remission via biopsy to the relapse of the disease.

    Measured: Assessed during the first 4 months, then at least every three months for 2 years. then every six months until five years after study entry, and every 12 months thereafter.

Secondary outcomes (1)

  1. Overall Survival (Consolidation Phase)

    Overall survival is defined as the time from randomization in the consolidation phase to death.

    Measured: Assessed during the first 4 months, then at least every three months for 2 years. then every six months until five years after study entry, and every 12 months thereafter.

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 start19 Dec 2002
  3. Primary completionMar 2009
  4. Study completionDec 2019

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
657 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00049517
Sponsor's protocol ID
CDR0000258113
Other IDs
U10CA021115, E1900
Status last verified
Jun 2023
First submitted
12 Nov 2002
Last updated
15 Jun 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Fernandez HF, Sun Z, Yao X, Litzow MR, Luger SM, Paietta EM, Racevskis J, Dewald GW, Ketterling RP, Bennett JM, Rowe JM, Lazarus HM, Tallman MS. Anthracycline dose intensification in acute myeloid leukemia. N Engl J Med. 2009 Sep 24;361(13):1249-59. doi: 10.1056/NEJMoa0904544.

    PubMed 19776406

  • Fernandez HF, Sun Z, Bennett JM, et al.: A single dose of gemtuzumab-ozogamicin (GO) in consolidation prior to autologous transplant for younger patients with newly diagnosed acute myeloid (AML) is safe but has no effect on disease free survival: interim results of Eastern Cooperative Oncology Group study (E1900). [Abstract] Biol Blood Marrow Transplant 14 (2): A-52, 21-2, 2008.

  • Vance GH, Kim H, Hicks GA, Cherry AM, Higgins R, Hulshizer RL, Tallman MS, Fernandez HF, Dewald GW. Utility of interphase FISH to stratify patients into cytogenetic risk categories at diagnosis of AML in an Eastern Cooperative Oncology Group (ECOG) clinical trial (E1900). Leuk Res. 2007 May;31(5):605-9. doi: 10.1016/j.leukres.2006.07.026. Epub 2006 Sep 22.

    PubMed 16996130

  • Fernandez HF, Kim HT, Bennett JM, et al.: Gemtuzumab-ozogamicin (GO; mylotarg®) as part of consolidation therapy for AML before autograft: low incidence of hepatic veno-occlusive disease. [Abstract] Biol Blood Marrow Transplant 11 (2 Suppl 1): A-187, 2005.

  • Gonen M, Sun Z, Figueroa ME, Patel JP, Abdel-Wahab O, Racevskis J, Ketterling RP, Fernandez H, Rowe JM, Tallman MS, Melnick A, Levine RL, Paietta E. CD25 expression status improves prognostic risk classification in AML independent of established biomarkers: ECOG phase 3 trial, E1900. Blood. 2012 Sep 13;120(11):2297-306. doi: 10.1182/blood-2012-02-414425. Epub 2012 Aug 1.

    PubMed 22855599

  • Fernandez HF, Sun Z, Litzow MR, Luger SM, Paietta EM, Racevskis J, Dewald G, Ketterling RP, Rowe JM, Lazarus HM, Tallman MS. Autologous transplantation gives encouraging results for young adults with favorable-risk acute myeloid leukemia, but is not improved with gemtuzumab ozogamicin. Blood. 2011 May 19;117(20):5306-13. doi: 10.1182/blood-2010-09-309229. Epub 2011 Mar 17.

    PubMed 21415269

  • Zarnegar-Lumley S, Alonzo TA, Gerbing RB, Othus M, Sun Z, Ries RE, Wang J, Leonti A, Kutny MA, Ostronoff F, Radich JP, Appelbaum FR, Pogosova-Agadjanyan EL, O'Dwyer K, Tallman MS, Litzow M, Atallah E, Cooper TM, Aplenc RA, Abdel-Wahab O, Gamis AS, Luger S, Erba H, Levine R, Kolb EA, Stirewalt DL, Meshinchi S, Tarlock K. Characteristics and prognostic impact of IDH mutations in AML: a COG, SWOG, and ECOG analysis. Blood Adv. 2023 Oct 10;7(19):5941-5953. doi: 10.1182/bloodadvances.2022008282.

    PubMed 37267439

  • Foran JM, Sun Z, Lai C, Fernandez HF, Cripe LD, Ketterling RP, Racevskis J, Luger SM, Paietta E, Lazarus HM, Zhang Y, Bennett JM, Levine RL, Rowe JM, Litzow MR, Tallman MS. Obesity in adult acute myeloid leukemia is not associated with inferior response or survival even when dose capping anthracyclines: An ECOG-ACRIN analysis. Cancer. 2023 Aug 15;129(16):2479-2490. doi: 10.1002/cncr.34807. Epub 2023 Apr 25.

    PubMed 37185873

  • Ganzel C, Sun Z, Baslan T, Zhang Y, Gonen M, Abdel-Wahab OI, Racevskis J, Garrett-Bakelman F, Lowe SW, Fernandez HF, Ketterling R, Luger SM, Litzow M, Lazarus HM, Rowe JM, Tallman MS, Levine RL, Paietta E. Measurable residual disease by flow cytometry in acute myeloid leukemia is prognostic, independent of genomic profiling. Leuk Res. 2022 Dec;123:106971. doi: 10.1016/j.leukres.2022.106971. Epub 2022 Oct 21.

    PubMed 36332294

  • Luskin MR, Gimotty PA, Smith C, Loren AW, Figueroa ME, Harrison J, Sun Z, Tallman MS, Paietta EM, Litzow MR, Melnick AM, Levine RL, Fernandez HF, Luger SM, Carroll M, Master SR, Wertheim GB. A clinical measure of DNA methylation predicts outcome in de novo acute myeloid leukemia. JCI Insight. 2016 Jun 16;1(9):e87323. doi: 10.1172/jci.insight.87323.

    PubMed 27446991

  • Luskin MR, Lee JW, Fernandez HF, Abdel-Wahab O, Bennett JM, Ketterling RP, Lazarus HM, Levine RL, Litzow MR, Paietta EM, Patel JP, Racevskis J, Rowe JM, Tallman MS, Sun Z, Luger SM. Benefit of high-dose daunorubicin in AML induction extends across cytogenetic and molecular groups. Blood. 2016 Mar 24;127(12):1551-8. doi: 10.1182/blood-2015-07-657403. Epub 2016 Jan 11.

    PubMed 26755712

  • Walter RB, Othus M, Paietta EM, Racevskis J, Fernandez HF, Lee JW, Sun Z, Tallman MS, Patel J, Gonen M, Abdel-Wahab O, Levine RL, Estey EH. Effect of genetic profiling on prediction of therapeutic resistance and survival in adult acute myeloid leukemia. Leukemia. 2015 Oct;29(10):2104-7. doi: 10.1038/leu.2015.76. Epub 2015 Mar 16. No abstract available.

    PubMed 25772026

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing sargramostim, busulfan and cyclophosphamide in people with Leukemia, run by Eastern Cooperative Oncology Group at 99 sites in 2 countries.

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

Who may be eligible to take part?

The sponsor lists 30 inclusion and 13 exclusion criteria. 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: finished, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 99 sites in United States, Israel. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Feb 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Overall Survival (Induction Phase) (time frame: Assessed during the first 4 months, then at least every three months for 2 years. then every six months until 5 years after study entry and every 12 months thereafter.). The study lists 2 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 NCT00049517, which also lists 12 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 15 Jun 2023.

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