Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002771
Status:
UNKNOWN
Last Update Posted:
2013-08-02
First Post:
1999-11-01
Brief Title:
Chemotherapy Interferon and Bone Marrow Transplantation in Treating Patients With Chronic Myelogenous Leukemia
Sponsor:
German CML Study Group
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
PROSPECTIVE CONTROLLED STUDY FOR THE OPTIMIZATION OF THERAPY IN CHRONIC MYELOID LEUKEMIA CML MULTICENTRIC STUDY FOR THE EVALUATION OF INTERFERON ALPHA VS ALLOGENIC BM TRANSPLANTATION WITH CHEMOTHERAPY IN CML
Status:
UNKNOWN
Status Verified Date:
2000-07
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 Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die Combining chemotherapy with 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 various combination chemotherapy regimens or bone marrow transplantation in treating patients with chronic myelogenous leukemia
PURPOSE Randomized phase III trial to compare the effectiveness of various combination chemotherapy regimens or bone marrow transplantation in treating patients with chronic myelogenous leukemia
Detailed Description:
OBJECTIVES
Compare the duration of chronic phase chronic myelogenous leukemia CML and survival of these patients treated with standard remission induction comprising hydroxyurea HU and interferon alfa IFN-A followed by allogeneic bone marrow transplantation and consolidation comprising HU and IFN-A vs cytarabine and idarubicin
Compare the frequency of hematologic and cytogenetic remission including elimination of Philadelphia-positive andor BCRABL-positive chromosome abnormalities time to remission and duration of remission in patients treated with these regimens
Correlate the quality of hematologic and cytogenetic remission with the survival of patients treated with these regimens
Compare the toxic effects of these regimens in these patients
Compare the disease progression in patients treated with these regimens
Correlate the duration of chronic phase CML and survival with prognostic criteria and the significance of normal vs subnormal leukocyte counts in patients treated with these regimens
Compare the survival of patients without a suitable allogeneic bone marrow donor treated with autologous bone marrow transplantation as consolidation therapy vs consolidation and maintenance chemotherapy regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center eligibility for allogeneic bone marrow transplantation Allo-BMT yes vs no donor availability sibling vs unrelated vs none and risk status high vs low
Induction therapy
Patients receive induction therapy comprising oral hydroxyurea HU until WBC falls below 10000mm3 and interferon alfa IFN-A subcutaneously SC daily beginning after WBC reduction and continuing in order to maintain WBC between 2000-4000mm3 and platelet count greater than 50000mm3 If WBC is 10000mm3 or greater on IFN-A alone then HU must be restarted Patients with disease progression and no anti-IFN antibody also receive cytarabine ARA-C SC for 15 days a months Patients who develop disease progression while receiving ARA-C and IFN-A are taken off study
Patients who are eligible for Allo-BMT have a sibling donor and are age 55 and under receive induction therapy for a maximum of 1 year and then proceed to regimen B Patients who are eligible for Allo-BMT have an unrelated donor and are age 45 and under receive induction therapy for 12-18 months Those patients with cytogenetic remission receive induction therapy for up to 2 years and then proceed to regimen B Those patients without cytogenetic remission proceed directly to regimen B Patients who are ineligible for Allo-BMT but are eligible for autologous BMT AuBMT or peripheral blood stem cell transplantation PBSCT receive induction therapy for a maximum of 1 year and then proceed to regimen C Patients who are ineligible for Allo-BMT and achieve hematologic complete remission CR within 3 months receive induction therapy for 18 months Those patients with cytogenetic remission proceed directly to regimen A Those patients without cytogenetic remission proceed to randomization on regimen B Patients who are ineligible for Allo-BMT and fail to achieve hematologic CR within 9 months proceed to randomization on regimen B All other patients who are ineligible for Allo-BMT receive induction therapy for 1 year Those patients with cytogenetic remission proceed to regimen A Those patients without cytogenetic remission proceed to randomization on regimen B
Consolidationmaintenance therapy
Patients are assigned to 1 of 3 regimens
Regimen A Patients continue to receive IFN-A as in induction therapy in the absence of disease progression
Regimen B Patients receive conditioning therapy comprising busulfan for 4 days andor total body irradiation followed by Allo-BMT Patients are then randomized to 1 of 2 treatment arms
Arm I Patients receive consolidation therapy comprising HU and IFN-A as in induction therapy
Arm II Patients receive consolidation therapy comprising ARA-C SC every 12 hours on days 1-5 and idarubicin IDA IV on days 3 and 4 and day 5 for patients with responding disease Consolidation therapy continues every 2 months for a total of 3 courses When blood counts recover patients receive maintenance therapy comprising IFN-A and ARA-C if needed as in induction therapy
Regimen C Patients receive IDA and ARA-C as in arm II Patients then undergo AuBMT or PBSCT
Patients are followed every 3-6 months for at least 4 years
PROJECTED ACCRUAL Approximately 750 patients will be accrued for this study within 5 years
Compare the duration of chronic phase chronic myelogenous leukemia CML and survival of these patients treated with standard remission induction comprising hydroxyurea HU and interferon alfa IFN-A followed by allogeneic bone marrow transplantation and consolidation comprising HU and IFN-A vs cytarabine and idarubicin
Compare the frequency of hematologic and cytogenetic remission including elimination of Philadelphia-positive andor BCRABL-positive chromosome abnormalities time to remission and duration of remission in patients treated with these regimens
Correlate the quality of hematologic and cytogenetic remission with the survival of patients treated with these regimens
Compare the toxic effects of these regimens in these patients
Compare the disease progression in patients treated with these regimens
Correlate the duration of chronic phase CML and survival with prognostic criteria and the significance of normal vs subnormal leukocyte counts in patients treated with these regimens
Compare the survival of patients without a suitable allogeneic bone marrow donor treated with autologous bone marrow transplantation as consolidation therapy vs consolidation and maintenance chemotherapy regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center eligibility for allogeneic bone marrow transplantation Allo-BMT yes vs no donor availability sibling vs unrelated vs none and risk status high vs low
Induction therapy
Patients receive induction therapy comprising oral hydroxyurea HU until WBC falls below 10000mm3 and interferon alfa IFN-A subcutaneously SC daily beginning after WBC reduction and continuing in order to maintain WBC between 2000-4000mm3 and platelet count greater than 50000mm3 If WBC is 10000mm3 or greater on IFN-A alone then HU must be restarted Patients with disease progression and no anti-IFN antibody also receive cytarabine ARA-C SC for 15 days a months Patients who develop disease progression while receiving ARA-C and IFN-A are taken off study
Patients who are eligible for Allo-BMT have a sibling donor and are age 55 and under receive induction therapy for a maximum of 1 year and then proceed to regimen B Patients who are eligible for Allo-BMT have an unrelated donor and are age 45 and under receive induction therapy for 12-18 months Those patients with cytogenetic remission receive induction therapy for up to 2 years and then proceed to regimen B Those patients without cytogenetic remission proceed directly to regimen B Patients who are ineligible for Allo-BMT but are eligible for autologous BMT AuBMT or peripheral blood stem cell transplantation PBSCT receive induction therapy for a maximum of 1 year and then proceed to regimen C Patients who are ineligible for Allo-BMT and achieve hematologic complete remission CR within 3 months receive induction therapy for 18 months Those patients with cytogenetic remission proceed directly to regimen A Those patients without cytogenetic remission proceed to randomization on regimen B Patients who are ineligible for Allo-BMT and fail to achieve hematologic CR within 9 months proceed to randomization on regimen B All other patients who are ineligible for Allo-BMT receive induction therapy for 1 year Those patients with cytogenetic remission proceed to regimen A Those patients without cytogenetic remission proceed to randomization on regimen B
Consolidationmaintenance therapy
Patients are assigned to 1 of 3 regimens
Regimen A Patients continue to receive IFN-A as in induction therapy in the absence of disease progression
Regimen B Patients receive conditioning therapy comprising busulfan for 4 days andor total body irradiation followed by Allo-BMT Patients are then randomized to 1 of 2 treatment arms
Arm I Patients receive consolidation therapy comprising HU and IFN-A as in induction therapy
Arm II Patients receive consolidation therapy comprising ARA-C SC every 12 hours on days 1-5 and idarubicin IDA IV on days 3 and 4 and day 5 for patients with responding disease Consolidation therapy continues every 2 months for a total of 3 courses When blood counts recover patients receive maintenance therapy comprising IFN-A and ARA-C if needed as in induction therapy
Regimen C Patients receive IDA and ARA-C as in arm II Patients then undergo AuBMT or PBSCT
Patients are followed every 3-6 months for at least 4 years
PROJECTED ACCRUAL Approximately 750 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-95042 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000064743 | REGISTRY | None | None |