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

Sponsor
Eastern Cooperative Oncology Group (Other)
Overall Status
Completed
CT.gov ID
NCT00049517
Collaborator
National Cancer Institute (NCI) (NIH)
657
Enrollment
99
Locations
6
Arms
204
Actual Duration (Months)
6.6
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
Phase 3

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
  1. 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
657 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase III Trial in Adult Acute Myeloid Leukemia: Daunorubicin Dose-Intensification Prior to Risk-Allocated Autologous Stem Cell Transplantation
Actual Study Start Date :
Dec 1, 2002
Actual Primary Completion Date :
Mar 1, 2009
Actual Study Completion Date :
Dec 1, 2019

Arms and Interventions

ArmIntervention/Treatment
Experimental: Standard Daunorubicin Then Autologous HCT

Induction: 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.

Biological: sargramostim
Given IV or as an injection
Other Names:
  • Leukine
  • Drug: busulfan
    Given IV
    Other Names:
  • Myleran
  • Drug: cyclophosphamide
    Given IV
    Other Names:
  • Endoxan
  • Cytoxan
  • Neosar
  • Procytox
  • Revimmune
  • cytophosphane
  • Drug: cytarabine
    Given as a continuous infusion
    Other Names:
  • cytosine arabinoside
  • Drug: Daunorubicin
    Given intravenously daily for 3 days at a dose of either 45 or 90 mg/m2.
    Other Names:
  • daunomycin
  • daunomycin cerubidine
  • Procedure: Autologous HCT
    Autologous hematopoietic cell transplantation
    Other Names:
  • Autologous hematopoietic cell transplantation
  • Experimental: High-dose Daunorubicin Then Autologous HCT

    Induction: 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.

    Biological: sargramostim
    Given IV or as an injection
    Other Names:
  • Leukine
  • Drug: busulfan
    Given IV
    Other Names:
  • Myleran
  • Drug: cyclophosphamide
    Given IV
    Other Names:
  • Endoxan
  • Cytoxan
  • Neosar
  • Procytox
  • Revimmune
  • cytophosphane
  • Drug: cytarabine
    Given as a continuous infusion
    Other Names:
  • cytosine arabinoside
  • Drug: Daunorubicin
    Given intravenously daily for 3 days at a dose of either 45 or 90 mg/m2.
    Other Names:
  • daunomycin
  • daunomycin cerubidine
  • Procedure: Autologous HCT
    Autologous hematopoietic cell transplantation
    Other Names:
  • Autologous hematopoietic cell transplantation
  • Experimental: Standard Daunorubicin Then GO/Autologous HCT

    Induction: 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.

    Biological: sargramostim
    Given IV or as an injection
    Other Names:
  • Leukine
  • Drug: busulfan
    Given IV
    Other Names:
  • Myleran
  • Drug: cyclophosphamide
    Given IV
    Other Names:
  • Endoxan
  • Cytoxan
  • Neosar
  • Procytox
  • Revimmune
  • cytophosphane
  • Drug: cytarabine
    Given as a continuous infusion
    Other Names:
  • cytosine arabinoside
  • Drug: gemtuzumab ozogamicin (GO)
    Given IV
    Other Names:
  • Mylotarg
  • Drug: Daunorubicin
    Given intravenously daily for 3 days at a dose of either 45 or 90 mg/m2.
    Other Names:
  • daunomycin
  • daunomycin cerubidine
  • Procedure: Autologous HCT
    Autologous hematopoietic cell transplantation
    Other Names:
  • Autologous hematopoietic cell transplantation
  • Experimental: High-dose Daunorubicin Then GO/Autologous HCT

    Induction: 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.

    Biological: sargramostim
    Given IV or as an injection
    Other Names:
  • Leukine
  • Drug: busulfan
    Given IV
    Other Names:
  • Myleran
  • Drug: cyclophosphamide
    Given IV
    Other Names:
  • Endoxan
  • Cytoxan
  • Neosar
  • Procytox
  • Revimmune
  • cytophosphane
  • Drug: cytarabine
    Given as a continuous infusion
    Other Names:
  • cytosine arabinoside
  • Drug: gemtuzumab ozogamicin (GO)
    Given IV
    Other Names:
  • Mylotarg
  • Drug: Daunorubicin
    Given intravenously daily for 3 days at a dose of either 45 or 90 mg/m2.
    Other Names:
  • daunomycin
  • daunomycin cerubidine
  • Procedure: Autologous HCT
    Autologous hematopoietic cell transplantation
    Other Names:
  • Autologous hematopoietic cell transplantation
  • Active Comparator: Standard Daunorubicin Then Allogeneic HCT or no Consolidation

    Induction: 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.

    Drug: cytarabine
    Given as a continuous infusion
    Other Names:
  • cytosine arabinoside
  • Drug: Daunorubicin
    Given intravenously daily for 3 days at a dose of either 45 or 90 mg/m2.
    Other Names:
  • daunomycin
  • daunomycin cerubidine
  • Procedure: Allogeneic HCT
    Allogeneic hematopoietic cell transplantation
    Other Names:
  • Allogeneic hematopoietic cell transplantation
  • Experimental: High-dose Daunorubicin Then Allogeneic HCT or no Consolidation

    Induction: 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.

    Drug: cytarabine
    Given as a continuous infusion
    Other Names:
  • cytosine arabinoside
  • Drug: Daunorubicin
    Given intravenously daily for 3 days at a dose of either 45 or 90 mg/m2.
    Other Names:
  • daunomycin
  • daunomycin cerubidine
  • Procedure: Allogeneic HCT
    Allogeneic hematopoietic cell transplantation
    Other Names:
  • Allogeneic hematopoietic cell transplantation
  • Outcome Measures

    Primary Outcome Measures

    1. Overall Survival (Induction Phase) [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.]

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

    2. Disease-free 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.]

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

    Secondary Outcome Measures

    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.]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • 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)

    • 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

    Exclusion Criteria:
    • 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

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Lurleen Wallace Comprehensive Cancer at University of Alabama - BirminghamBirminghamAlabamaUnited States35294
    2Mayo Clinic ScottsdaleScottsdaleArizonaUnited States85259-5499
    3Aurora Presbyterian HospitalAuroraColoradoUnited States80012
    4Penrose Cancer Center at Penrose HospitalColorado SpringsColoradoUnited States80933
    5St. Anthony Central HospitalDenverColoradoUnited States80204
    6Porter Adventist HospitalDenverColoradoUnited States80210
    7Presbyterian - St. Luke's Medical CenterDenverColoradoUnited States80218
    8St. Joseph HospitalDenverColoradoUnited States80218
    9Rose Medical CenterDenverColoradoUnited States80220
    10CCOP - Colorado Cancer Research ProgramDenverColoradoUnited States80224-2522
    11Swedish Medical CenterEnglewoodColoradoUnited States80110
    12St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical CenterGrand JunctionColoradoUnited States81502
    13North Colorado Medical CenterGreeleyColoradoUnited States80631
    14Sky Ridge Medical CenterLone TreeColoradoUnited States80124
    15Hope Cancer Care Center at Longmont United HospitalLongmontColoradoUnited States80502
    16McKee Medical CenterLovelandColoradoUnited States80539
    17St. Mary - Corwin Regional Medical CenterPuebloColoradoUnited States81004
    18North Suburban Medical CenterThorntonColoradoUnited States80229
    19Exempla Lutheran Medical CenterWheat RidgeColoradoUnited States80033
    20Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - WestBoca RatonFloridaUnited States33428
    21Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - Main CampusBoca RatonFloridaUnited States33486
    22University of Florida Shands Cancer CenterGainesvilleFloridaUnited States32610-0232
    23University of Miami Sylvester Comprehensive Cancer Center - MiamiMiamiFloridaUnited States33136
    24Winship Cancer Institute of Emory UniversityAtlantaGeorgiaUnited States30322
    25Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicagoIllinoisUnited States60611-3013
    26Hematology and Oncology AssociatesChicagoIllinoisUnited States60611
    27Evanston Northwestern Healthcare - Evanston HospitalEvanstonIllinoisUnited States60201-1781
    28Midwest Center for Hematology/OncologyJolietIllinoisUnited States60432
    29Joliet Oncology-Hematology Associates, Limited - WestJolietIllinoisUnited States60435
    30North Shore Oncology and Hematology Associates, Limited - LibertyvilleLibertyvilleIllinoisUnited States60048
    31La Grange Oncology Associates - GenevaNapervilleIllinoisUnited States60563
    32Cancer Care and Hematology Specialists of Chicagoland - NilesNilesIllinoisUnited States60714
    33Advocate Lutheran General Cancer Care CenterPark RidgeIllinoisUnited States60068-1174
    34Hematology Oncology Associates - SkokieSkokieIllinoisUnited States60076
    35Carle Cancer Center at Carle Foundation HospitalUrbanaIllinoisUnited States61801
    36CCOP - Carle Cancer CenterUrbanaIllinoisUnited States61801
    37Fort Wayne Medical Oncology and HematologyFort WayneIndianaUnited States46815
    38Indiana University Melvin and Bren Simon Cancer CenterIndianapolisIndianaUnited States46202-5289
    39Tufts-NEMC Cancer CenterBostonMassachusettsUnited States02111
    40Borgess Medical CenterKalamazooMichiganUnited States49001
    41West Michigan Cancer CenterKalamazooMichiganUnited States49007-3731
    42Bronson Methodist HospitalKalamazooMichiganUnited States49007
    43MeritCare BemidjiBemidjiMinnesotaUnited States56601
    44Fairview Ridges HospitalBurnsvilleMinnesotaUnited States55337
    45Mercy and Unity Cancer Center at Mercy HospitalCoon RapidsMinnesotaUnited States55433
    46Fairview Southdale HospitalEdinaMinnesotaUnited States55435
    47Mercy and Unity Cancer Center at Unity HospitalFridleyMinnesotaUnited States55432
    48Minnesota Oncology Hematology, PA - MaplewoodMaplewoodMinnesotaUnited States55109
    49Virginia Piper Cancer Institute at Abbott - Northwestern HospitalMinneapolisMinnesotaUnited States55407
    50Hubert H. Humphrey Cancer Center at North Memorial Outpatient CenterRobbinsdaleMinnesotaUnited States55422-2900
    51Mayo Clinic Cancer CenterRochesterMinnesotaUnited States55905
    52CCOP - Metro-MinnesotaSaint Louis ParkMinnesotaUnited States55416
    53Park Nicollet Cancer CenterSaint Louis ParkMinnesotaUnited States55416
    54United HospitalSaint PaulMinnesotaUnited States55102
    55Ridgeview Medical CenterWaconiaMinnesotaUnited States55387
    56Minnesota Oncology Hematology, PA - WoodburyWoodburyMinnesotaUnited States55125
    57CCOP - Montana Cancer ConsortiumBillingsMontanaUnited States59101
    58Hematology-Oncology Centers of the Northern Rockies - BillingsBillingsMontanaUnited States59101
    59Northern Rockies Radiation Oncology CenterBillingsMontanaUnited States59101
    60St. Vincent Healthcare Cancer Care ServicesBillingsMontanaUnited States59101
    61Billings Clinic - DowntownBillingsMontanaUnited States59107-7000
    62Bozeman Deaconess Cancer CenterBozemanMontanaUnited States59715
    63St. James Healthcare Cancer CareButteMontanaUnited States59701
    64Great Falls Clinic - Main FacilityGreat FallsMontanaUnited States59405
    65Great Falls ClinicGreat FallsMontanaUnited States59405
    66St. Peter's HospitalHelenaMontanaUnited States59601
    67Glacier Oncology, PLLCKalispellMontanaUnited States59901
    68Kalispell Medical Oncology at KRMCKalispellMontanaUnited States59901
    69Kalispell Regional Medical CenterKalispellMontanaUnited States59901
    70Community Medical CenterMissoulaMontanaUnited States59801
    71Guardian Oncology and Center for WellnessMissoulaMontanaUnited States59804
    72Montana Cancer Specialists at Montana Cancer CenterMissoulaMontanaUnited States59807-7877
    73Montana Cancer Center at St. Patrick Hospital and Health Sciences CenterMissoulaMontanaUnited States59807
    74Albert Einstein Cancer Center at Albert Einstein College of MedicineBronxNew YorkUnited States10461
    75NYU Cancer Institute at New York University Medical CenterNew YorkNew YorkUnited States10016
    76CCOP - MeritCare HospitalFargoNorth DakotaUnited States58122
    77MeritCare BroadwayFargoNorth DakotaUnited States58122
    78Mercy Cancer Center at Mercy Medical CenterCantonOhioUnited States44708
    79Aultman Cancer Center at Aultman HospitalCantonOhioUnited States44710-1799
    80Jewish Hospital Cancer CenterCincinnatiOhioUnited States45236
    81St. Rita's Medical CenterLimaOhioUnited States45801
    82Geisinger Cancer Institute at Geisinger HealthDanvillePennsylvaniaUnited States17822-0001
    83Penn State Cancer Institute at Milton S. Hershey Medical CenterHersheyPennsylvaniaUnited States17033-0850
    84Abramson Cancer Center of the University of PennsylvaniaPhiladelphiaPennsylvaniaUnited States19104-4283
    85Fox Chase Cancer Center - PhiladelphiaPhiladelphiaPennsylvaniaUnited States19111-2497
    86UPMC Cancer CentersPittsburghPennsylvaniaUnited States15232
    87Geisinger Medical Group - Scenery ParkState CollegePennsylvaniaUnited States16801
    88Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical CenterWilkes-BarrePennsylvaniaUnited States18711
    89Vanderbilt-Ingram Cancer CenterNashvilleTennesseeUnited States37232-6838
    90Virginia Commonwealth University Massey Cancer CenterRichmondVirginiaUnited States23298-0037
    91Marshfield Clinic Cancer Care at Regional Cancer CenterEau ClaireWisconsinUnited States54701
    92Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical CenterLa CrosseWisconsinUnited States54601
    93University of Wisconsin Paul P. Carbone Comprehensive Cancer CenterMadisonWisconsinUnited States53792-6164
    94Marshfield Clinic - Marshfield CenterMarshfieldWisconsinUnited States54449
    95Saint Joseph's HospitalMarshfieldWisconsinUnited States54449
    96Ministry Medical Group at Saint Mary's HospitalRhinelanderWisconsinUnited States54501
    97Marshfield Clinic - Weston CenterWestonWisconsinUnited States54476
    98Welch Cancer Center at Sheridan Memorial HospitalSheridanWyomingUnited States82801
    99Rambam Medical CenterHaifaIsrael31096

    Sponsors and Collaborators

    • Eastern Cooperative Oncology Group
    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: Hugo F. Fernandez, MD, H. Lee Moffitt Cancer Center and Research Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Eastern Cooperative Oncology Group
    ClinicalTrials.gov Identifier:
    NCT00049517
    Other Study ID Numbers:
    • CDR0000258113
    • U10CA021115
    • E1900
    First Posted:
    Jan 27, 2003
    Last Update Posted:
    Nov 17, 2020
    Last Verified:
    Oct 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Eastern Cooperative Oncology Group
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment DetailsFrom December 2002 through November 2008, a total of 657 patients were enrolled in the study.
    Pre-assignment Detail
    Arm/Group TitleStandard Daunorubicin Then Autologous HCTHigh-dose Daunorubicin Then Autologous HCTStandard Daunorubicin Then GO/Autologous HCTHigh-dose Daunorubicin Then GO/Autologous HCTStandard Daunorubicin Then Allogeneic HCT or no ConsolidationHigh-dose Daunorubicin Then Allogeneic HCT or no Consolidation
    Arm/Group DescriptionInduction: 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.Induction: 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.Induction: 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.Induction: 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.Induction: 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.Induction: 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.
    Period Title: Induction
    STARTED79906375188162
    Treated79906375186160
    COMPLETED79906375128108
    NOT COMPLETED00006054
    Period Title: Induction
    STARTED799063752124
    Randomized to Autologous HCT +/- GO5973637500
    COMPLETED274025321518
    NOT COMPLETED5250384366

    Baseline Characteristics

    Arm/Group TitleStandard Daunorubicin (Induction Therapy)High Dose Daunorubicin (Induction Therapy)Total
    Arm/Group DescriptionPatients 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.Patients receive high-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine as in arm I. Patients may receive a second course of induction therapy if CR is not achieved after the first course. The second course is administered as in arm I.Total of all reporting groups
    Overall Participants330327657
    Age (years) [Median (Full Range) ]
    Median (Full Range) [years]
    47
    48
    48
    Sex: Female, Male (Count of Participants)
    Female
    158
    47.9%
    164
    50.2%
    322
    49%
    Male
    172
    52.1%
    163
    49.8%
    335
    51%

    Outcome Measures

    1. Primary Outcome
    TitleOverall Survival (Induction Phase)
    DescriptionOverall survival is defined as the time from randomization in the induction phase to death.
    Time FrameAssessed 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.

    Outcome Measure Data

    Analysis Population Description
    All randomized patients are included in the analysis (intention-to-treat).
    Arm/Group TitleStandard DaunorubicinHigh-dose Daunorubicin
    Arm/Group DescriptionInduction: 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. Patients with CR received consolidation treatment thereafter.Induction: 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. Patients with CR received consolidation treatment thereafter.
    Measure Participants330327
    Median (95% Confidence Interval) [months]
    15.7
    23.7
    2. Primary Outcome
    TitleDisease-free Survival (Consolidation Phase)
    DescriptionDisease-free survival is defined from the time of the confirmation of a complete remission via biopsy to the relapse of the disease.
    Time FrameAssessed 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.

    Outcome Measure Data

    Analysis Population Description
    Only 270 patients who were randomized in the consolidation phase are included in the analysis.
    Arm/Group TitleAutologous HCTGo/Autologous HCT
    Arm/Group DescriptionPatients with CR in the induction phase were randomized to receive autologous HCT or GO/autologous HCT.Patients with CR in the induction phase were randomized to receive autologous HCT or GO/autologous HCT.
    Measure Participants132138
    Median (95% Confidence Interval) [Months]
    15.0
    13.6
    3. Secondary Outcome
    TitleOverall Survival (Consolidation Phase)
    DescriptionOverall survival is defined as the time from randomization in the consolidation phase to death.
    Time FrameAssessed 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.

    Outcome Measure Data

    Analysis Population Description
    Only 270 patients who were randomized in the consolidation phase are included in the analysis.
    Arm/Group TitleAutologous HCTGo/Autologous HCT
    Arm/Group DescriptionPatients with CR in the induction phase were randomized to receive autologous HCT or GO/autologous HCT.Patients with CR in the induction phase were randomized to receive autologous HCT or GO/autologous HCT.
    Measure Participants132138
    Median (95% Confidence Interval) [Months]
    35.5
    27.9

    Adverse Events

    Time FrameAssessed weekly while on treatment and for 30 days after the end of treatment.
    Adverse Event Reporting Description
    Arm/Group TitleStandard Daunorubicin (Induction Therapy)High Dose Daunorubicin (Induction Therapy)
    Arm/Group DescriptionInduction: 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. Conditioning/Transplant: 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 peripheral blood stem cell (PBSC) transplantation on day 0. Patients receive sargramostim (GM-CSF) or filgrastim (G-CSF) IV or subcutaneously (SC) beginning on day 0 and continuing until blood counts recover.Induction: Patients receive high-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine as in arm I. Patients may receive a second course of induction therapy if CR is not achieved after the first course. The second course is administered as in arm I. Conditioning/Transplant: 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.
    All Cause Mortality
    Standard Daunorubicin (Induction Therapy)High Dose Daunorubicin (Induction Therapy)
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total/ (NaN) / (NaN)
    Serious Adverse Events
    Standard Daunorubicin (Induction Therapy)High Dose Daunorubicin (Induction Therapy)
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total328/328 (100%) 325/325 (100%)
    Blood and lymphatic system disorders
    Anemia257/328 (78.4%) 251/325 (77.2%)
    Hemolysis1/328 (0.3%) 0/325 (0%)
    Leukopenia320/328 (97.6%) 323/325 (99.4%)
    Lymphopenia3/328 (0.9%) 4/325 (1.2%)
    Neutropenia319/328 (97.3%) 305/325 (93.8%)
    Thrombocytopenia321/328 (97.9%) 321/325 (98.8%)
    Transfusion platelets199/328 (60.7%) 206/325 (63.4%)
    Transfusion: PRBCS197/328 (60.1%) 191/325 (58.8%)
    Hematologic-other1/328 (0.3%) 0/325 (0%)
    Hypertension5/328 (1.5%) 2/325 (0.6%)
    Hypotension9/328 (2.7%) 12/325 (3.7%)
    Thrombosis4/328 (1.2%) 2/325 (0.6%)
    Weight gain1/328 (0.3%) 0/325 (0%)
    DIC5/328 (1.5%) 2/325 (0.6%)
    Bilirubin Increased13/328 (4%) 15/325 (4.6%)
    Hypoalbuminemia5/328 (1.5%) 3/325 (0.9%)
    AST increased3/328 (0.9%) 4/325 (1.2%)
    ALT Increased10/328 (3%) 5/325 (1.5%)
    Febrile neutropenia121/328 (36.9%) 117/325 (36%)
    Hypokalemia0/328 (0%) 1/325 (0.3%)
    CNS hemorrhage2/328 (0.6%) 1/325 (0.3%)
    Petechiae5/328 (1.5%) 2/325 (0.6%)
    Cardiac disorders
    Sinus Tachycardia0/328 (0%) 2/325 (0.6%)
    Supraventricular arrhythmias1/328 (0.3%) 6/325 (1.8%)
    Ventricular arrthhmia1/328 (0.3%) 2/325 (0.6%)
    Arrhythmia-other0/328 (0%) 1/325 (0.3%)
    Acute Vascular leak syndrome0/328 (0%) 1/325 (0.3%)
    Cardiac ischemia0/328 (0%) 1/325 (0.3%)
    Cardiac-Left Ventricular Function0/328 (0%) 4/325 (1.2%)
    Cardiac Troponin I1/328 (0.3%) 0/325 (0%)
    Pericardial Effusion/Pericarditis2/328 (0.6%) 0/325 (0%)
    Cardiac-other1/328 (0.3%) 2/325 (0.6%)
    Ear and labyrinth disorders
    Stomatitis9/328 (2.7%) 20/325 (6.2%)
    Gastrointestinal disorders
    Colitis6/328 (1.8%) 8/325 (2.5%)
    Diarrhea2/328 (0.6%) 1/325 (0.3%)
    Dysphagia2/328 (0.6%) 4/325 (1.2%)
    Nausea19/328 (5.8%) 16/325 (4.9%)
    Typhlitis6/328 (1.8%) 9/325 (2.8%)
    Vomiting7/328 (2.1%) 8/325 (2.5%)
    Constipation0/328 (0%) 1/325 (0.3%)
    Ileus0/328 (0%) 3/325 (0.9%)
    Proctitis4/328 (1.2%) 0/325 (0%)
    Diarrhea w/o prior colostomy7/328 (2.1%) 12/325 (3.7%)
    Diarrhea w/ prior colostomy1/328 (0.3%) 1/325 (0.3%)
    GI-other1/328 (0.3%) 3/325 (0.9%)
    Hematemesis1/328 (0.3%) 0/325 (0%)
    Melena/GI Bleeding0/328 (0%) 4/325 (1.2%)
    Rectal Bleeding1/328 (0.3%) 1/325 (0.3%)
    Abdominal Pain4/328 (1.2%) 3/325 (0.9%)
    Rectal or Perirectal Pain2/328 (0.6%) 2/325 (0.6%)
    General disorders
    VOD1/328 (0.3%) 1/325 (0.3%)
    Edema1/328 (0.3%) 0/325 (0%)
    Fatigue18/328 (5.5%) 19/325 (5.8%)
    Fever22/328 (6.7%) 29/325 (8.9%)
    Weight loss1/328 (0.3%) 3/325 (0.9%)
    Epistaxis8/328 (2.4%) 10/325 (3.1%)
    Dyspnea18/328 (5.5%) 13/325 (4%)
    Rigors/chills0/328 (0%) 1/325 (0.3%)
    Constitutional symptoms1/328 (0.3%) 0/325 (0%)
    Chest Pain1/328 (0.3%) 0/325 (0%)
    Pain-other5/328 (1.5%) 4/325 (1.2%)
    Infections and infestations
    Wound-infectious2/328 (0.6%) 1/325 (0.3%)
    Infection w/ Gr3-4 neutropenia154/328 (47%) 168/325 (51.7%)
    Catheter-Related Infection1/328 (0.3%) 4/325 (1.2%)
    Infection w/ unknown ANC1/328 (0.3%) 1/325 (0.3%)
    Infection w/o neutropenia10/328 (3%) 13/325 (4%)
    Infection- Other1/328 (0.3%) 1/325 (0.3%)
    Acidosis0/328 (0%) 1/325 (0.3%)
    Injury, poisoning and procedural complications
    Operative Injury of Vein/Artery1/328 (0.3%) 0/325 (0%)
    Wound - non-infectious0/328 (0%) 1/325 (0.3%)
    Hemorrhage with Grade 3 or 4 Platelets30/328 (9.1%) 36/325 (11.1%)
    Hemorrhage without Grade 3 or 4 Platelets0/328 (0%) 1/325 (0.3%)
    Hemorrhage Associated with Surgery1/328 (0.3%) 1/325 (0.3%)
    Investigations
    PTT1/328 (0.3%) 0/325 (0%)
    SIADH1/328 (0.3%) 0/325 (0%)
    Alkaline phosphatase increased1/328 (0.3%) 6/325 (1.8%)
    Creatinine increased2/328 (0.6%) 1/325 (0.3%)
    Metabolism and nutrition disorders
    hyperglycemia7/328 (2.1%) 4/325 (1.2%)
    Dehydration0/328 (0%) 1/325 (0.3%)
    Hypernatremia0/328 (0%) 1/325 (0.3%)
    Hypocalcemia4/328 (1.2%) 3/325 (0.9%)
    Hypokalemia11/328 (3.4%) 9/325 (2.8%)
    Hyponatremia6/328 (1.8%) 8/325 (2.5%)
    Hypophosphatemia3/328 (0.9%) 4/325 (1.2%)
    Tumor Lysis Syndrome2/328 (0.6%) 2/325 (0.6%)
    Musculoskeletal and connective tissue disorders
    Bone Marrow Cellularity0/328 (0%) 1/325 (0.3%)
    Arthritis1/328 (0.3%) 0/325 (0%)
    Muscle Weakness1/328 (0.3%) 0/325 (0%)
    Myositis0/328 (0%) 1/325 (0.3%)
    Joint, Muscle, Bone-Other1/328 (0.3%) 0/325 (0%)
    Arthralgia2/328 (0.6%) 3/325 (0.9%)
    Bone, pain2/328 (0.6%) 2/325 (0.6%)
    Myalgia1/328 (0.3%) 3/325 (0.9%)
    Nervous system disorders
    Ataxia0/328 (0%) 1/325 (0.3%)
    Dizziness/Lightheadedness4/328 (1.2%) 0/325 (0%)
    Neuropathy-motor1/328 (0.3%) 0/325 (0%)
    Neuropathy-sensory0/328 (0%) 1/325 (0.3%)
    Seizure1/328 (0.3%) 1/325 (0.3%)
    Speech Impairment1/328 (0.3%) 0/325 (0%)
    Syncope6/328 (1.8%) 0/325 (0%)
    Ocular-Other2/328 (0.6%) 0/325 (0%)
    Headache4/328 (1.2%) 4/325 (1.2%)
    Psychiatric disorders
    Anorexia26/328 (7.9%) 32/325 (9.8%)
    Confusion3/328 (0.9%) 5/325 (1.5%)
    Depressed Level of consciousness0/328 (0%) 2/325 (0.6%)
    Hallucinations2/328 (0.6%) 0/325 (0%)
    Insomnia1/328 (0.3%) 0/325 (0%)
    Anxiety/Agitation2/328 (0.6%) 2/325 (0.6%)
    Depression0/328 (0%) 2/325 (0.6%)
    Renal and urinary disorders
    Hematuria1/328 (0.3%) 2/325 (0.6%)
    Renal Failure3/328 (0.9%) 3/325 (0.9%)
    Reproductive system and breast disorders
    Vaginal Bleeding3/328 (0.9%) 1/325 (0.3%)
    Respiratory, thoracic and mediastinal disorders
    Hemoptysis2/328 (0.6%) 3/325 (0.9%)
    Pleuritic Pain0/328 (0%) 2/325 (0.6%)
    ARDS3/328 (0.9%) 1/325 (0.3%)
    Cough1/328 (0.3%) 0/325 (0%)
    Dyspnea18/328 (5.5%) 13/325 (4%)
    Hypoxia12/328 (3.7%) 14/325 (4.3%)
    Pleural effusion2/328 (0.6%) 4/325 (1.2%)
    Pneumonitis/pulmonary infiltrates7/328 (2.1%) 11/325 (3.4%)
    Skin and subcutaneous tissue disorders
    Pruritus2/328 (0.6%) 2/325 (0.6%)
    Rash17/328 (5.2%) 16/325 (4.9%)
    Hand-Foot Reaction1/328 (0.3%) 0/325 (0%)
    Skin- Other1/328 (0.3%) 0/325 (0%)
    Vascular disorders
    Hot flashes0/328 (0%) 1/325 (0.3%)
    Hemorrhage-Other1/328 (0.3%) 1/325 (0.3%)
    Other (Not Including Serious) Adverse Events
    Standard Daunorubicin (Induction Therapy)High Dose Daunorubicin (Induction Therapy)
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total319/328 (97.3%) 318/325 (97.8%)
    Blood and lymphatic system disorders
    Anemia319/328 (97.3%) 318/325 (97.8%)
    Leukopenia281/328 (85.7%) 267/325 (82.2%)
    Neutropenia243/328 (74.1%) 230/325 (70.8%)
    Thrombocytopenia295/328 (89.9%) 292/325 (89.8%)
    General disorders
    Nausea16/328 (4.9%) 18/325 (5.5%)
    Fatigue11/328 (3.4%) 18/325 (5.5%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/TitleStatistician
    OrganizationECOG Statistical Office
    Phone617-632-3012
    Email
    Responsible Party:
    Eastern Cooperative Oncology Group
    ClinicalTrials.gov Identifier:
    NCT00049517
    Other Study ID Numbers:
    • CDR0000258113
    • U10CA021115
    • E1900
    First Posted:
    Jan 27, 2003
    Last Update Posted:
    Nov 17, 2020
    Last Verified:
    Oct 1, 2020