Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00025402
Status:
UNKNOWN
Last Update Posted:
2013-12-18
First Post:
2001-10-11
Brief Title:
Chemotherapy and Biological Therapy With or Without Bone Marrow or Peripheral Stem Cell Transplant in Treating Patients With Chronic Myelogenous Leukemia
Sponsor:
III Medizinische Klinik Mannheim
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Randomized Multicenter Treatment Optimization Study In Chronic Myeloid Leukemia CML Interferon-a Vs Allogeneic Stem Cell Transplantation Vs High-Dose Chemotherapy Followed By Autografting And Interferon-a Maintainance In Early Chronic Phase
Status:
UNKNOWN
Status Verified Date:
2002-07
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 chemotherapy such as hydroxyurea cytarabine idarubicin and etoposide before a donor bone marrow transplant or stem cell transplant helps stop the growth of cancer cells It also helps stop the patients immune system from rejecting the donors stem cells Interferon alfa may interfere with the growth of cancer cells and slow the growth of cancer When the healthy stem cells from a donor are infused into the patient they may help the patients bone marrow make stem cells red blood cells white blood cells and platelets It is not yet known whether chemotherapy is more effective with or without interferon alfa andor bone marrow or stem cell transplant in treating patients with chronic myelogenous leukemia
PURPOSE This randomized phase III trial is studying chemotherapy and biological therapy to see how well it works compared with chemotherapy biological therapy and donor bone marrow transplant or autologous stem cell transplant in treating patients with chronic phase chronic myelogenous leukemia
PURPOSE This randomized phase III trial is studying chemotherapy and biological therapy to see how well it works compared with chemotherapy biological therapy and donor bone marrow transplant or autologous stem cell transplant in treating patients with chronic phase chronic myelogenous leukemia
Detailed Description:
OBJECTIVES
Compare survival in patients with chronic myelogenous leukemia in early chronic phase treated with allogeneic bone marrow transplantation vs drug treatment with or without autologous peripheral blood stem cell transplantation
Compare survival of patients with late-phase disease treated with high-dose cytarabine vs low-dose cytarabine followed by autografting and interferon alfa maintenance
Compare survival of patients not responding cytogenetically to treatment with continued interferon alfa vs hydroxyurea
Determine frequency time-point and duration of hematological and cytogenetic remissions and of Philadelphia chromosome-negative andor BCR-ABL-positive cells on the various treatments
Correlate the quality of hematological and cytogenetic remissions with survival time in patients treated with these regimens
Compare the course of the terminal phase in patients treated with these regimens
Compare the toxic effects of these regimens in these patients
Determine the effect of prognostic criteria and normal or subnormal WBC on chronic phase duration and survival time in patients treated with these regimens
Compare the effect of early vs late high-dose therapy plus autografting on feasibility toxicity and survival times in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to eligibility for transplantation yes vs no
All patients undergo cytoreduction comprising hydroxyurea HU IV daily
Patients who are ineligible for or refuse transplantation are randomized to 1 of 2 treatment arms
Arm I Patients receive interferon alfa IFN subcutaneously SC daily After 2 weeks of IFN therapy patients also receive low-dose cytarabine ARA-C SC once daily for 10-15 days each month Patients who do not achieve cytogenetic remission within 12 months continue to receive HU
Arm II Patients receive IFN SC daily After 2 weeks of IFN therapy patients also receive low-dose ARA-C SC daily for 10-15 days each month Patients who do not achieve cytogenetic remission within 12 months continue to receive IFN therapy SC daily
Patients who are eligible for transplantation with a related donor undergo allogeneic bone marrow transplantation Patients may receive HU or IFN prior to transplantation Patients may also receive oral high-dose busulfan daily for 4 days with or without cyclophosphamide or cyclophosphamide with total body irradiation
Patients who are eligible for transplantation but do not have a related donor undergo peripheral blood stem cell PBSC harvest and are randomized to 1 of 2 treatment arms
Arm III Patients receive IFN and low-dose ARA-C as in arm I Patients who accelerate on treatment may undergo autologous PBSC transplantation
Arm IV Patients receive idarubicin IV ARA-C IV over 2 hours and etoposide IV on days 1-3 Patients then undergo leukapheresis Beginning on day 8 patients receive filgrastim G-CSF SC daily until end of leukapheresis Patients then receive oral high-dose busulfan daily for 4 consecutive days The following day patients undergo reinfusion of autologous PBSC After blood count recovery patients receive maintenance IFN 3 times weekly for 8 weeks and then daily
Patients are followed every 3 months for 3 years and then every 6 months thereafter
PROJECTED ACCRUAL A total of 1000 patients will be accrued for this study within 5 years
Compare survival in patients with chronic myelogenous leukemia in early chronic phase treated with allogeneic bone marrow transplantation vs drug treatment with or without autologous peripheral blood stem cell transplantation
Compare survival of patients with late-phase disease treated with high-dose cytarabine vs low-dose cytarabine followed by autografting and interferon alfa maintenance
Compare survival of patients not responding cytogenetically to treatment with continued interferon alfa vs hydroxyurea
Determine frequency time-point and duration of hematological and cytogenetic remissions and of Philadelphia chromosome-negative andor BCR-ABL-positive cells on the various treatments
Correlate the quality of hematological and cytogenetic remissions with survival time in patients treated with these regimens
Compare the course of the terminal phase in patients treated with these regimens
Compare the toxic effects of these regimens in these patients
Determine the effect of prognostic criteria and normal or subnormal WBC on chronic phase duration and survival time in patients treated with these regimens
Compare the effect of early vs late high-dose therapy plus autografting on feasibility toxicity and survival times in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to eligibility for transplantation yes vs no
All patients undergo cytoreduction comprising hydroxyurea HU IV daily
Patients who are ineligible for or refuse transplantation are randomized to 1 of 2 treatment arms
Arm I Patients receive interferon alfa IFN subcutaneously SC daily After 2 weeks of IFN therapy patients also receive low-dose cytarabine ARA-C SC once daily for 10-15 days each month Patients who do not achieve cytogenetic remission within 12 months continue to receive HU
Arm II Patients receive IFN SC daily After 2 weeks of IFN therapy patients also receive low-dose ARA-C SC daily for 10-15 days each month Patients who do not achieve cytogenetic remission within 12 months continue to receive IFN therapy SC daily
Patients who are eligible for transplantation with a related donor undergo allogeneic bone marrow transplantation Patients may receive HU or IFN prior to transplantation Patients may also receive oral high-dose busulfan daily for 4 days with or without cyclophosphamide or cyclophosphamide with total body irradiation
Patients who are eligible for transplantation but do not have a related donor undergo peripheral blood stem cell PBSC harvest and are randomized to 1 of 2 treatment arms
Arm III Patients receive IFN and low-dose ARA-C as in arm I Patients who accelerate on treatment may undergo autologous PBSC transplantation
Arm IV Patients receive idarubicin IV ARA-C IV over 2 hours and etoposide IV on days 1-3 Patients then undergo leukapheresis Beginning on day 8 patients receive filgrastim G-CSF SC daily until end of leukapheresis Patients then receive oral high-dose busulfan daily for 4 consecutive days The following day patients undergo reinfusion of autologous PBSC After blood count recovery patients receive maintenance IFN 3 times weekly for 8 weeks and then daily
Patients are followed every 3 months for 3 years and then every 6 months thereafter
PROJECTED ACCRUAL A total of 1000 patients will be accrued for this study within 5 years
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 |
|---|---|---|---|
| EU-20118 | None | None | None |
| III-MK-CML-3A | None | None | None |