Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002719
Status:
COMPLETED
Last Update Posted:
2012-07-02
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy With or Without G-CSF in Treating Older Patients With Acute Myeloid Leukemia
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
RANDOMIZED PHASE III STUDY TO EVALUATE THE VALUE OF rHuG-CSF IN INDUCTION AND OF AN ORAL SCHEDULE AS CONSOLIDATION TREATMENT IN ELDERLY PATIENTS WITH ACUTE MYELOGENOUS LEUMEKIA AML-13 PROTOCOL
Status:
COMPLETED
Status Verified Date:
2012-06
Last Known Status:
None
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 Colony-stimulating factors such as G-CSF may increase the number of immune cells found in the bone marrow or peripheral blood and may help a persons immune system recover after chemotherapy and radiation therapy Combining more than one drug and giving drugs in different ways may kill more cancer cells
PURPOSE Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without G-CSF in treating older patients with acute myeloid leukemia
PURPOSE Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without G-CSF in treating older patients with acute myeloid leukemia
Detailed Description:
OBJECTIVES I Assess the role of granulocyte colony-stimulating factor given during andor after remission induction with MICE mitoxantronecytarabineetoposide in elderly patients with acute myelogenous leukemia AML II Compare the complete remission CR rate and survival of these patients when treated with nearly equivalent doses of oral vs intravenous mini-ICE idarubicincytarabineetoposide as consolidation therapy given on an outpatient basis III Evaluate the feasibility of a second intensive consolidation regimen consisting of BAVC carmustineamsacrineetoposidecytarabine followed by autologous stem cell support in patients under age 71 who are in CR and have good performance status
OUTLINE Randomized study All patients are randomly assigned to Arms IA through ID for Induction Patients who achieve CR and who have adequate organ function and performance status are then randomly assigned to Arm IIA or IIB for Consolidation At selected centers patients in CR after their first Consolidation course who are under age 71 and in very good clinical condition are treated on Regimen A in lieu of a second Consolidation course The following acronyms are used AMSA Amsacrine NSC-249992 ARA-C Cytarabine NSC-63878 BAVC BCNUAMSAVP-16ARA-C BCNU Carmustine NSC-409962 DHAD Mitoxantrone NSC-301739 G-CSF Granulocyte Colony-Stimulating Factor Rhone-Poulenc Rorer IDA Idarubicin NSC-256439 MICE DHADARA-CVP-16 Mini-ICE IDAARA-CVP-16 PBSC Peripheral Blood Stem Cells VP-16 Etoposide NSC-141540 INDUCTION Arm IA 3-Drug Combination Chemotherapy MICE Arm IB 3-Drug Combination Chemotherapy plus Hematologic Toxicity Attenuation MICE plus G-CSF G-CSF during chemotherapy Arm IC 3-Drug Combination Chemotherapy plus Hematologic Toxicity Attenuation MICE plus G-CSF G-CSF after chemotherapy Arm ID 3-Drug Combination Chemotherapy plus Hematologic Toxicity Attenuation MICE plus G-CSF G-CSF during and after chemotherapy CONSOLIDATION Arm IIA 3-Drug Combination Chemotherapy Mini-ICE Intravenous IDAVP-16ARA-C Arm IIB 3-Drug Combination Chemotherapy Mini-ICE Oral IDAVP-16 subcutaneous ARA-C Regimen A Stem Cell Mobilization followed by 4-Drug Combination Myeloablative Chemotherapy with Stem Cell Rescue G-CSF followed by BAVC with PBSC
PROJECTED ACCRUAL 500 patients will be randomized for Induction of whom an anticipated 238 patients will be randomized for Consolidation If at interim analyses survival is shorter on Regimen A that regimen will be closed
OUTLINE Randomized study All patients are randomly assigned to Arms IA through ID for Induction Patients who achieve CR and who have adequate organ function and performance status are then randomly assigned to Arm IIA or IIB for Consolidation At selected centers patients in CR after their first Consolidation course who are under age 71 and in very good clinical condition are treated on Regimen A in lieu of a second Consolidation course The following acronyms are used AMSA Amsacrine NSC-249992 ARA-C Cytarabine NSC-63878 BAVC BCNUAMSAVP-16ARA-C BCNU Carmustine NSC-409962 DHAD Mitoxantrone NSC-301739 G-CSF Granulocyte Colony-Stimulating Factor Rhone-Poulenc Rorer IDA Idarubicin NSC-256439 MICE DHADARA-CVP-16 Mini-ICE IDAARA-CVP-16 PBSC Peripheral Blood Stem Cells VP-16 Etoposide NSC-141540 INDUCTION Arm IA 3-Drug Combination Chemotherapy MICE Arm IB 3-Drug Combination Chemotherapy plus Hematologic Toxicity Attenuation MICE plus G-CSF G-CSF during chemotherapy Arm IC 3-Drug Combination Chemotherapy plus Hematologic Toxicity Attenuation MICE plus G-CSF G-CSF after chemotherapy Arm ID 3-Drug Combination Chemotherapy plus Hematologic Toxicity Attenuation MICE plus G-CSF G-CSF during and after chemotherapy CONSOLIDATION Arm IIA 3-Drug Combination Chemotherapy Mini-ICE Intravenous IDAVP-16ARA-C Arm IIB 3-Drug Combination Chemotherapy Mini-ICE Oral IDAVP-16 subcutaneous ARA-C Regimen A Stem Cell Mobilization followed by 4-Drug Combination Myeloablative Chemotherapy with Stem Cell Rescue G-CSF followed by BAVC with PBSC
PROJECTED ACCRUAL 500 patients will be randomized for Induction of whom an anticipated 238 patients will be randomized for Consolidation If at interim analyses survival is shorter on Regimen A that regimen will be closed
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 |
|---|---|---|---|
| ITA-GIMEMA-AML13 | None | None | None |
| EORTC-06954 | None | None | None |