Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004128
Status:
UNKNOWN
Last Update Posted:
2009-12-23
First Post:
1999-12-10
Brief Title:
Combination Chemotherapy Interleukin-2 and Peripheral Stem Cell Transplant in Treating Patients With Acute Myeloid Leukemia
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
The Value of High Dose Versus Standard Dose ARA-C During Induction and of IL-2 After Intensive ConsolidationAutologous Stem Cell Transplantation in Patients Age 15-60 Years With Acute Myelogenous Leukemia A Randomized Phase II Trial of the EORTC and the GIMEMA-ALWP
Status:
UNKNOWN
Status Verified Date:
2008-04
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 Giving combination chemotherapy before a peripheral blood stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them After treatment stem cells are collected from the patients blood or bone marrow and stored More chemotherapy or radiation therapy is given prepare the bone marrow for the stem cell transplant The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy and radiation therapy Interleukin-2 may stimulate the patients white blood cells to kill cancer cells
PURPOSE This randomized phase III trial is studying two different regimens of combination chemotherapy interleukin-2 and peripheral stem cell transplant and comparing them to see how well they work in treating patients with acute myeloid leukemia
PURPOSE This randomized phase III trial is studying two different regimens of combination chemotherapy interleukin-2 and peripheral stem cell transplant and comparing them to see how well they work in treating patients with acute myeloid leukemia
Detailed Description:
OBJECTIVES
Compare the overall survival rate in patients with acute myeloid leukemia treated with high-dose versus standard-dose cytarabine during induction
Compare the disease-free survival rate in patients treated with or without interleukin-2 following consolidation and autologous peripheral blood stem cell or bone marrow transplantation
Compare the feasibility of these regimens in these patients
OUTLINE This is a randomized multicenter study Patients in the first randomization are stratified according to center WBC no greater than 25000mm3 vs 25000-99000mm3 vs at least 100000mm3 age 15 to 45 vs 46 to 60 and performance status 0-1 vs 2 vs 3 Patients in the second randomization are stratified according to center first treatment arm I vs II number of induction courses to reach complete remission CR cytogenicmolecular genetic group at diagnosis low vs high vs intermediate vs unknown and autologous peripheral blood stem cell PBSC transplantation planned after consolidation yes vs no
First randomization
Induction Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive standard-dose cytarabine IV over 24 hours on days 1-10 etoposide IV over 1 hour on days 1-5 and daunorubicin IV over 5 minutes on days 1 3 and 5
Arm II Patients receive etoposide and daunorubicin as in arm I and high-dose cytarabine IV over 3 hours every 12 hours on days 1 3 5 and 7
Consolidation When CR is reached patients receive intermediate-dose cytarabine IV over 2 hours every 12 hours on days 1-6 and daunorubicin IV over 5 minutes prior to cytarabine on days 4 5 and 6
Harvest Patients who achieve CR and are ineligible for allogeneic PBSC transplantation receive filgrastim G-CSF subcutaneously SQ every 12 hours beginning 20 days after starting consolidation treatment and continuing until autologous PBSC are harvested Autologous bone marrow is collected from patients with insufficient PBSC Allogeneic PBSC are harvested for patients who have an HLA identical donor Allogeneic bone marrow is harvested for high risk patients under age 40 who have an unrelated bone marrow donor
Transplant preparative chemotherapy It is recommended that patients receive cyclophosphamide on 2 consecutive days and total body irradiation on 3 days OR busulfan on days -8 -7 -6 and -5 followed by cyclophosphamide on days -4 and -3
Transplantation PBSC or bone marrow is infused on day 0
Second randomization
Patients who achieve CR with full hematologic recovery but have no HLA identical donor are randomized to 1 of 2 treatment arms no earlier than day 22 after stem cell infusion
Arm I Patients receive interleukin-2 SQ once daily for 5 days Treatment repeats every 4 weeks for 1 year in the absence of disease progression or unacceptable toxicity
Arm II Patients receive no further treatment Patients are followed at 1 4 and 13 months then every 4 months for 3 years and then every 6 months thereafter
PROJECTED ACCRUAL A total of 2000 patients 1000 per treatment arm will be accrued for the first randomization and a total of 577 patients 288 per treatment arm will be accrued for the second randomization of this study
Compare the overall survival rate in patients with acute myeloid leukemia treated with high-dose versus standard-dose cytarabine during induction
Compare the disease-free survival rate in patients treated with or without interleukin-2 following consolidation and autologous peripheral blood stem cell or bone marrow transplantation
Compare the feasibility of these regimens in these patients
OUTLINE This is a randomized multicenter study Patients in the first randomization are stratified according to center WBC no greater than 25000mm3 vs 25000-99000mm3 vs at least 100000mm3 age 15 to 45 vs 46 to 60 and performance status 0-1 vs 2 vs 3 Patients in the second randomization are stratified according to center first treatment arm I vs II number of induction courses to reach complete remission CR cytogenicmolecular genetic group at diagnosis low vs high vs intermediate vs unknown and autologous peripheral blood stem cell PBSC transplantation planned after consolidation yes vs no
First randomization
Induction Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive standard-dose cytarabine IV over 24 hours on days 1-10 etoposide IV over 1 hour on days 1-5 and daunorubicin IV over 5 minutes on days 1 3 and 5
Arm II Patients receive etoposide and daunorubicin as in arm I and high-dose cytarabine IV over 3 hours every 12 hours on days 1 3 5 and 7
Consolidation When CR is reached patients receive intermediate-dose cytarabine IV over 2 hours every 12 hours on days 1-6 and daunorubicin IV over 5 minutes prior to cytarabine on days 4 5 and 6
Harvest Patients who achieve CR and are ineligible for allogeneic PBSC transplantation receive filgrastim G-CSF subcutaneously SQ every 12 hours beginning 20 days after starting consolidation treatment and continuing until autologous PBSC are harvested Autologous bone marrow is collected from patients with insufficient PBSC Allogeneic PBSC are harvested for patients who have an HLA identical donor Allogeneic bone marrow is harvested for high risk patients under age 40 who have an unrelated bone marrow donor
Transplant preparative chemotherapy It is recommended that patients receive cyclophosphamide on 2 consecutive days and total body irradiation on 3 days OR busulfan on days -8 -7 -6 and -5 followed by cyclophosphamide on days -4 and -3
Transplantation PBSC or bone marrow is infused on day 0
Second randomization
Patients who achieve CR with full hematologic recovery but have no HLA identical donor are randomized to 1 of 2 treatment arms no earlier than day 22 after stem cell infusion
Arm I Patients receive interleukin-2 SQ once daily for 5 days Treatment repeats every 4 weeks for 1 year in the absence of disease progression or unacceptable toxicity
Arm II Patients receive no further treatment Patients are followed at 1 4 and 13 months then every 4 months for 3 years and then every 6 months thereafter
PROJECTED ACCRUAL A total of 2000 patients 1000 per treatment arm will be accrued for the first randomization and a total of 577 patients 288 per treatment arm will be accrued for the second randomization of this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| GIMEMA-EORTC-06991 | None | None | None |
| EORTC-06991 | None | None | None |