Combination Chemotherapy With or Without Monoclonal Antibody Therapy in Treating Patients With AML Leukemia
A Phase III Trial in Adult Acute Myeloid Leukemia: Daunorubicin Dose-Intensification Prior to Risk-Allocated Autologous Stem Cell Transplantation
3 other identifiers
interventional
657
2 countries
99
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 leukemia
Started Dec 2002
Longer than P75 for phase_3 leukemia
99 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 12, 2002
CompletedStudy Start
First participant enrolled
December 19, 2002
CompletedFirst Posted
Study publicly available on registry
January 27, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedResults Posted
Study results publicly available
February 12, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedJune 15, 2023
June 1, 2023
6.2 years
November 12, 2002
January 10, 2013
June 13, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Overall Survival (Induction Phase)
Overall survival is defined as the time from randomization in the induction phase to death.
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.
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.
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)
Overall Survival (Consolidation Phase)
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.
Study Arms (6)
Standard Daunorubicin Then Autologous HCT
EXPERIMENTALInduction: 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 ÎĽg/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.
High-dose Daunorubicin Then Autologous HCT
EXPERIMENTALInduction: 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 ÎĽg/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.
Standard Daunorubicin Then GO/Autologous HCT
EXPERIMENTALInduction: 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 ÎĽg/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 ÎĽ/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.
High-dose Daunorubicin Then GO/Autologous HCT
EXPERIMENTALInduction: 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 ÎĽg/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 ÎĽ/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.
Standard Daunorubicin Then Allogeneic HCT or no Consolidation
ACTIVE 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/ÎĽL were to proceed to allogeneic HCT if they had a suitable human leukocyte antigen (HLA)-matched sibling donor available.
High-dose Daunorubicin Then Allogeneic HCT or no Consolidation
EXPERIMENTALInduction: 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/ÎĽL were to proceed to allogeneic HCT if they had a suitable human leukocyte antigen (HLA)-matched sibling donor available.
Interventions
Given IV or as an injection
Given IV
Given IV
Given as a continuous infusion
Given IV
Given intravenously daily for 3 days at a dose of either 45 or 90 mg/m2.
Autologous hematopoietic cell transplantation
Allogeneic hematopoietic cell transplantation
Eligibility Criteria
You may qualify if:
- 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)
- q23 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
- +15 more criteria
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (99)
Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
Birmingham, Alabama, 35294, United States
Mayo Clinic Scottsdale
Scottsdale, Arizona, 85259-5499, United States
Aurora Presbyterian Hospital
Aurora, Colorado, 80012, United States
Penrose Cancer Center at Penrose Hospital
Colorado Springs, Colorado, 80933, United States
St. Anthony Central Hospital
Denver, Colorado, 80204, United States
Porter Adventist Hospital
Denver, Colorado, 80210, United States
Presbyterian - St. Luke's Medical Center
Denver, Colorado, 80218, United States
St. Joseph Hospital
Denver, Colorado, 80218, United States
Rose Medical Center
Denver, Colorado, 80220, United States
CCOP - Colorado Cancer Research Program
Denver, Colorado, 80224-2522, United States
Swedish Medical Center
Englewood, Colorado, 80110, United States
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
Grand Junction, Colorado, 81502, United States
North Colorado Medical Center
Greeley, Colorado, 80631, United States
Sky Ridge Medical Center
Lone Tree, Colorado, 80124, United States
Hope Cancer Care Center at Longmont United Hospital
Longmont, Colorado, 80502, United States
McKee Medical Center
Loveland, Colorado, 80539, United States
St. Mary - Corwin Regional Medical Center
Pueblo, Colorado, 81004, United States
North Suburban Medical Center
Thornton, Colorado, 80229, United States
Exempla Lutheran Medical Center
Wheat Ridge, Colorado, 80033, United States
Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - West
Boca Raton, Florida, 33428, United States
Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - Main Campus
Boca Raton, Florida, 33486, United States
University of Florida Shands Cancer Center
Gainesville, Florida, 32610-0232, United States
University of Miami Sylvester Comprehensive Cancer Center - Miami
Miami, Florida, 33136, United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, 60611-3013, United States
Hematology and Oncology Associates
Chicago, Illinois, 60611, United States
Evanston Northwestern Healthcare - Evanston Hospital
Evanston, Illinois, 60201-1781, United States
Midwest Center for Hematology/Oncology
Joliet, Illinois, 60432, United States
Joliet Oncology-Hematology Associates, Limited - West
Joliet, Illinois, 60435, United States
North Shore Oncology and Hematology Associates, Limited - Libertyville
Libertyville, Illinois, 60048, United States
La Grange Oncology Associates - Geneva
Naperville, Illinois, 60563, United States
Cancer Care and Hematology Specialists of Chicagoland - Niles
Niles, Illinois, 60714, United States
Advocate Lutheran General Cancer Care Center
Park Ridge, Illinois, 60068-1174, United States
Hematology Oncology Associates - Skokie
Skokie, Illinois, 60076, United States
Carle Cancer Center at Carle Foundation Hospital
Urbana, Illinois, 61801, United States
CCOP - Carle Cancer Center
Urbana, Illinois, 61801, United States
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, 46815, United States
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202-5289, United States
Tufts-NEMC Cancer Center
Boston, Massachusetts, 02111, United States
Borgess Medical Center
Kalamazoo, Michigan, 49001, United States
West Michigan Cancer Center
Kalamazoo, Michigan, 49007-3731, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007, United States
MeritCare Bemidji
Bemidji, Minnesota, 56601, United States
Fairview Ridges Hospital
Burnsville, Minnesota, 55337, United States
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids, Minnesota, 55433, United States
Fairview Southdale Hospital
Edina, Minnesota, 55435, United States
Mercy and Unity Cancer Center at Unity Hospital
Fridley, Minnesota, 55432, United States
Minnesota Oncology Hematology, PA - Maplewood
Maplewood, Minnesota, 55109, United States
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
Robbinsdale, Minnesota, 55422-2900, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905, United States
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, 55416, United States
Park Nicollet Cancer Center
Saint Louis Park, Minnesota, 55416, United States
United Hospital
Saint Paul, Minnesota, 55102, United States
Ridgeview Medical Center
Waconia, Minnesota, 55387, United States
Minnesota Oncology Hematology, PA - Woodbury
Woodbury, Minnesota, 55125, United States
CCOP - Montana Cancer Consortium
Billings, Montana, 59101, United States
Hematology-Oncology Centers of the Northern Rockies - Billings
Billings, Montana, 59101, United States
Northern Rockies Radiation Oncology Center
Billings, Montana, 59101, United States
St. Vincent Healthcare Cancer Care Services
Billings, Montana, 59101, United States
Billings Clinic - Downtown
Billings, Montana, 59107-7000, United States
Bozeman Deaconess Cancer Center
Bozeman, Montana, 59715, United States
St. James Healthcare Cancer Care
Butte, Montana, 59701, United States
Great Falls Clinic - Main Facility
Great Falls, Montana, 59405, United States
Great Falls Clinic
Great Falls, Montana, 59405, United States
St. Peter's Hospital
Helena, Montana, 59601, United States
Glacier Oncology, PLLC
Kalispell, Montana, 59901, United States
Kalispell Medical Oncology at KRMC
Kalispell, Montana, 59901, United States
Kalispell Regional Medical Center
Kalispell, Montana, 59901, United States
Community Medical Center
Missoula, Montana, 59801, United States
Guardian Oncology and Center for Wellness
Missoula, Montana, 59804, United States
Montana Cancer Specialists at Montana Cancer Center
Missoula, Montana, 59807-7877, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula, Montana, 59807, United States
NYU Cancer Institute at New York University Medical Center
New York, New York, 10016, United States
Albert Einstein Cancer Center at Albert Einstein College of Medicine
The Bronx, New York, 10461, United States
CCOP - MeritCare Hospital
Fargo, North Dakota, 58122, United States
MeritCare Broadway
Fargo, North Dakota, 58122, United States
Mercy Cancer Center at Mercy Medical Center
Canton, Ohio, 44708, United States
Aultman Cancer Center at Aultman Hospital
Canton, Ohio, 44710-1799, United States
Jewish Hospital Cancer Center
Cincinnati, Ohio, 45236, United States
St. Rita's Medical Center
Lima, Ohio, 45801, United States
Geisinger Cancer Institute at Geisinger Health
Danville, Pennsylvania, 17822-0001, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033-0850, United States
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104-4283, United States
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, 19111-2497, United States
UPMC Cancer Centers
Pittsburgh, Pennsylvania, 15232, United States
Geisinger Medical Group - Scenery Park
State College, Pennsylvania, 16801, United States
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, 18711, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838, United States
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, 23298-0037, United States
Marshfield Clinic Cancer Care at Regional Cancer Center
Eau Claire, Wisconsin, 54701, United States
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601, United States
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, 53792-6164, United States
Marshfield Clinic - Marshfield Center
Marshfield, Wisconsin, 54449, United States
Saint Joseph's Hospital
Marshfield, Wisconsin, 54449, United States
Ministry Medical Group at Saint Mary's Hospital
Rhinelander, Wisconsin, 54501, United States
Marshfield Clinic - Weston Center
Weston, Wisconsin, 54476, United States
Welch Cancer Center at Sheridan Memorial Hospital
Sheridan, Wyoming, 82801, United States
Rambam Medical Center
Haifa, 31096, Israel
Related Publications (12)
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.
PMID: 19776406RESULTFernandez 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.
RESULTVance 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.
PMID: 16996130RESULTFernandez 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.
RESULTGonen 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.
PMID: 22855599RESULTFernandez 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.
PMID: 21415269RESULTZarnegar-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.
PMID: 37267439DERIVEDForan 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.
PMID: 37185873DERIVEDGanzel 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.
PMID: 36332294DERIVEDLuskin 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.
PMID: 27446991DERIVEDLuskin 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.
PMID: 26755712DERIVEDWalter 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.
PMID: 25772026DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Statistician
- Organization
- ECOG Statistical Office
Study Officials
- STUDY CHAIR
Hugo F. Fernandez, MD
H. Lee Moffitt Cancer Center and Research Institute
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 12, 2002
First Posted
January 27, 2003
Study Start
December 19, 2002
Primary Completion
March 1, 2009
Study Completion
December 1, 2019
Last Updated
June 15, 2023
Results First Posted
February 12, 2013
Record last verified: 2023-06