Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002549
Status:
UNKNOWN
Last Update Posted:
2009-12-23
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy Followed by Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Acute Myelogenous Leukemia
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
RANDOMIZED PHASE III STUDY OF INDUCTION ICE VS MICE VS DCE AND INTENSIVE CONSOLIDATION IDIA VS NOVIA VS DIA FOLLOWED BY BONE MARROW TRANSPLANTATION IN ACUTE MYELOGENOUS LEUKEMIA AML 10 PROTOCOL
Status:
UNKNOWN
Status Verified Date:
2009-12
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die Combining chemotherapy with peripheral stem cell or bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells
PURPOSE Randomized phase III trial to compare the effectiveness of combination chemotherapy followed by bone marrow or peripheral stem cell transplantation in treating patients with acute myelogenous leukemia
PURPOSE Randomized phase III trial to compare the effectiveness of combination chemotherapy followed by bone marrow or peripheral stem cell transplantation in treating patients with acute myelogenous leukemia
Detailed Description:
OBJECTIVES I Determine the complete remission CR rate following 1 or 2 courses of ICE idarubicincytarabineetoposide vs MICE mitoxantronecytarabineetoposide vs DCE daunorubicincytarabineetoposide in patients with newly diagnosed acute myeloid leukemia II Compare disease-free survival and overall survival achieved with each anthracycline on the above induction regimens and with intermediate-dose cytarabine IDIA vs NOVIA vs DIA as consolidation therapy III Compare disease-free survival relapse rate death in first CR and overall survival in patients who receive peripheral blood stem cells PBSC vs autologous bone marrow transplant AuBMT vs allogeneic bone marrow transplant AlBMT as rescue from myeloablative therapy following remission consolidation IV Assess the time to recovery of normal or acceptable polymorphonuclear leukocyte and platelet counts following each treatment step V Determine the incidence and type of grade 4 toxicity and treatment-related mortality VI Evaluate the quality of life during each step of treatment using self-administered questionnaires VII Compare stem cell mobilization after IDIA vs NOVIA vs DIA each using granulocyte colony-stimulating factor as the mobilizing growth factor VIII Assess the rate of completion of stem cell transplantation using PBSC vs AlBMT vs AuBMT as the last step of therapy IX Compare the costs of treatment eg antibiotics and transfusion requirements and hospitalization duration between the AuBMT vs PBSC
OUTLINE Randomized study All patients are randomized to Arms I II and III for InductionConsolidation Patients in CR following Consolidation who have an HLA-identical sibling are less than 45 or 55 years of age depending on center policy and have adequate organ function are nonrandomly assigned to AlBMT on Regimen A those in CR who are without an available sibling donor and who have adequate organ function proceed to Regimen B then are randomized to Arms IV and V The following acronyms are used AlBMT Allogeneic Bone Marrow Transplant ARA-C Cytarabine NSC-63878 AuBMT Autologous Bone Marrow Transplant BU Busulfan NSC-750 CTX Cyclophosphamide NSC-26271 DCE DNRARA-CVP-16 DHAD Mitoxantrone NSC-301739 DIA DNRID ARA-C DNR Daunorubicin NSC-82151 G-CSF Granulocyte Colony-Stimulating Factor Rhone-Poulenc-Rorer ICE IDAARA-CVP-16 IDA Idarubicin NSC-256439 ID Intermediate Dose IDIA IDAID ARA-C Mesna Mercaptoethane sulfonate NSC-113891 MICE DHADARA-CVP-16 NOVIA DHADID ARA-C PBSC Peripheral Blood Stem Cells TBI Total-Body Irradiation VP-16 Etoposide NSC-141540 INDUCTIONCONSOLIDATION Arm I 3-Drug Combination Chemotherapy followed by 2-Drug Combination Chemotherapy ICE followed by IDIA Arm II 3-Drug Combination Chemotherapy followed by 2-Drug Combination Chemotherapy MICE followed by NOVIA Arm III 3-Drug Combination Chemotherapy followed by 2-Drug Combination Chemotherapy DCE followed by DIA POSTCONSOLIDATION THERAPY Regimen A Single-Agent Chemoablation plus Radioablation or 2-Drug Chemoablation followed by Hematopoietic Rescue CTX plus TBI equipment unspecified or CTXBU followed by AlBMT Entry on EORTC study comparing CI IDA with standard CTXTBI or CTXBU encouraged Regimen B Stem cell Mobilization and Harvest G-CSF or CTXG-CSF Arm IV Single-Agent Chemoablation plus Radioablation or 2-Drug Chemoablation followed by Hematopoietic Rescue CTXTBI or CTXBU followed by PBSC Arm V Single-Agent Chemoablation plus Radioablation or 2-Drug Chemoablation followed by Hematopoietic Rescue CTXTBI or CTXBU followed by AuBMT
PROJECTED ACCRUAL 1520 patients will be randomized for InductionConsolidation over about 5 years if excessive deaths are found at interim analyses the inferior arm will close It is expected that 744 patients will be randomized for Postconsolidation therapy with 345 patients followed until relapsedeath
OUTLINE Randomized study All patients are randomized to Arms I II and III for InductionConsolidation Patients in CR following Consolidation who have an HLA-identical sibling are less than 45 or 55 years of age depending on center policy and have adequate organ function are nonrandomly assigned to AlBMT on Regimen A those in CR who are without an available sibling donor and who have adequate organ function proceed to Regimen B then are randomized to Arms IV and V The following acronyms are used AlBMT Allogeneic Bone Marrow Transplant ARA-C Cytarabine NSC-63878 AuBMT Autologous Bone Marrow Transplant BU Busulfan NSC-750 CTX Cyclophosphamide NSC-26271 DCE DNRARA-CVP-16 DHAD Mitoxantrone NSC-301739 DIA DNRID ARA-C DNR Daunorubicin NSC-82151 G-CSF Granulocyte Colony-Stimulating Factor Rhone-Poulenc-Rorer ICE IDAARA-CVP-16 IDA Idarubicin NSC-256439 ID Intermediate Dose IDIA IDAID ARA-C Mesna Mercaptoethane sulfonate NSC-113891 MICE DHADARA-CVP-16 NOVIA DHADID ARA-C PBSC Peripheral Blood Stem Cells TBI Total-Body Irradiation VP-16 Etoposide NSC-141540 INDUCTIONCONSOLIDATION Arm I 3-Drug Combination Chemotherapy followed by 2-Drug Combination Chemotherapy ICE followed by IDIA Arm II 3-Drug Combination Chemotherapy followed by 2-Drug Combination Chemotherapy MICE followed by NOVIA Arm III 3-Drug Combination Chemotherapy followed by 2-Drug Combination Chemotherapy DCE followed by DIA POSTCONSOLIDATION THERAPY Regimen A Single-Agent Chemoablation plus Radioablation or 2-Drug Chemoablation followed by Hematopoietic Rescue CTX plus TBI equipment unspecified or CTXBU followed by AlBMT Entry on EORTC study comparing CI IDA with standard CTXTBI or CTXBU encouraged Regimen B Stem cell Mobilization and Harvest G-CSF or CTXG-CSF Arm IV Single-Agent Chemoablation plus Radioablation or 2-Drug Chemoablation followed by Hematopoietic Rescue CTXTBI or CTXBU followed by PBSC Arm V Single-Agent Chemoablation plus Radioablation or 2-Drug Chemoablation followed by Hematopoietic Rescue CTXTBI or CTXBU followed by AuBMT
PROJECTED ACCRUAL 1520 patients will be randomized for InductionConsolidation over about 5 years if excessive deaths are found at interim analyses the inferior arm will close It is expected that 744 patients will be randomized for Postconsolidation therapy with 345 patients followed until relapsedeath
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EORTC-06931 | None | None | None |