Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00055874
Status:
COMPLETED
Last Update Posted:
2018-05-03
First Post:
2003-03-06
Brief Title:
Imatinib Mesylate With or Without Interferon Alfa or Cytarabine Compared With Interferon Alfa Followed by Donor Stem Cell Transplant in Treating Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia
Sponsor:
Heidelberg University
Organization:
Heidelberg University
Study Overview
Official Title:
Treatment Optimization Trial in Chronic Myeloid Leukemia CML - Randomized Controlled Comparison of Imatinib vs ImatinibInterferon-alpha vs ImatinibLow-Dose AraC vs Interferon-alpha Standard Therapy and Determination of the Role of Allografting in Newly Diagnosed Chronic Phase
Status:
COMPLETED
Status Verified Date:
2011-11
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 Giving chemotherapy before a donor bone marrow transplant helps stop the growth of cancer cells It also helps stop the patients immune system from rejecting the donors stem cells Also imatinib mesylate may stop the growth of cancer cells by blocking the enzymes needed for cancer cell growth 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 which treatment regimen is most effective in treating chronic phase chronic myelogenous leukemia
PURPOSE This randomized phase III trial is studying imatinib mesylate with or without interferon alfa or cytarabine to see how well it works compared with interferon alfa followed by donor stem cell transplant in treating patients with newly diagnosed chronic phase chronic myelogenous leukemia
PURPOSE This randomized phase III trial is studying imatinib mesylate with or without interferon alfa or cytarabine to see how well it works compared with interferon alfa followed by donor stem cell transplant in treating patients with newly diagnosed chronic phase chronic myelogenous leukemia
Detailed Description:
OBJECTIVES
Compare the hematologic cytogenetic and molecular response rates in patients with newly diagnosed chronic phase chronic myelogenous leukemia treated with imatinib mesylate alone or with interferon alfa or low-dose cytarabine vs interferon alfa standard therapy
Compare the group-dependent progression-free and overall survival and time to progression in patients treated with these regimens
Compare the efficacy of allogeneic stem cell transplantation vs imatinib mesylate-based therapy in patients eligible for transplantation
Compare the efficacy of reduced-intensity conditioning vs standard conditioning in patients over 45 years of age
Determine the time to and duration of hematologic cytogenetic and molecular responses and correlate these factors in patients treated with these regimens
Compare the short- and long-term adverse effects of these regimens in these patients
Compare the presentation duration and responses to therapy of accelerated and blastic phases in patients treated with these regimens
Determine the survival of high-risk patients after early allografting
Determine the influence of pre-transplantation therapies on the outcome of allogeneic stem cell transplantation in these patients
OUTLINE This is a randomized multicenter pilot study Patients are stratified according to participating center Patients with low- to intermediate-risk disease are randomized to 1 of 4 treatment arms Patients with high-risk disease are randomized to 1 of 3 treatment arms with imatinib mesylate-based regimens
Arm I Patients receive oral imatinib mesylate once daily for up to 12 months in the absence of disease progression or unacceptable toxicity
Arm II Patients receive oral imatinib mesylate as in arm I Patients also receive interferon alfa subcutaneously SC 3 times a week beginning at least 3 months after the start of imatinib mesylate
Arm III Patients receive oral imatinib mesylate as in arm I Patients also receive cytarabine SC up to twice daily for 5 days monthly beginning at least 3 months after the start of imatinib mesylate
Arm IV After initial cytoreduction with hydroxyurea patients receive interferon alfa SC daily with or without hydroxyurea In the absence of a complete response after 3 months patients may also receive low-dose cytarabine SC once daily Treatment continues for up to 21 months
Patients who fail interferon alfa therapy are crossed over to receive imatinib mesylate
Patients who fail therapy with imatinib mesylate and are eligible for an allogeneic transplantation are stratified according to availability of donor HLA-identical related vs unrelated status and participating center Patients are randomized to receive an allogeneic transplantation or continue any salvage therapy
Patients who are not eligible for allogeneic transplantation receive hydroxyurea and cytarabine or high-dose chemotherapy with autologous stem cell rescue followed by interferon- or imatinib mesylate-based therapy
Patients over 45 years of age are further randomized to receive an age-adjusted standard conditioning regimen or reduced intensity preparative regimen mini transplantation prior to allogeneic transplantation
Patients are followed every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 1600 patients 400 per treatment arm will be accrued for this study within 4-5 years
Compare the hematologic cytogenetic and molecular response rates in patients with newly diagnosed chronic phase chronic myelogenous leukemia treated with imatinib mesylate alone or with interferon alfa or low-dose cytarabine vs interferon alfa standard therapy
Compare the group-dependent progression-free and overall survival and time to progression in patients treated with these regimens
Compare the efficacy of allogeneic stem cell transplantation vs imatinib mesylate-based therapy in patients eligible for transplantation
Compare the efficacy of reduced-intensity conditioning vs standard conditioning in patients over 45 years of age
Determine the time to and duration of hematologic cytogenetic and molecular responses and correlate these factors in patients treated with these regimens
Compare the short- and long-term adverse effects of these regimens in these patients
Compare the presentation duration and responses to therapy of accelerated and blastic phases in patients treated with these regimens
Determine the survival of high-risk patients after early allografting
Determine the influence of pre-transplantation therapies on the outcome of allogeneic stem cell transplantation in these patients
OUTLINE This is a randomized multicenter pilot study Patients are stratified according to participating center Patients with low- to intermediate-risk disease are randomized to 1 of 4 treatment arms Patients with high-risk disease are randomized to 1 of 3 treatment arms with imatinib mesylate-based regimens
Arm I Patients receive oral imatinib mesylate once daily for up to 12 months in the absence of disease progression or unacceptable toxicity
Arm II Patients receive oral imatinib mesylate as in arm I Patients also receive interferon alfa subcutaneously SC 3 times a week beginning at least 3 months after the start of imatinib mesylate
Arm III Patients receive oral imatinib mesylate as in arm I Patients also receive cytarabine SC up to twice daily for 5 days monthly beginning at least 3 months after the start of imatinib mesylate
Arm IV After initial cytoreduction with hydroxyurea patients receive interferon alfa SC daily with or without hydroxyurea In the absence of a complete response after 3 months patients may also receive low-dose cytarabine SC once daily Treatment continues for up to 21 months
Patients who fail interferon alfa therapy are crossed over to receive imatinib mesylate
Patients who fail therapy with imatinib mesylate and are eligible for an allogeneic transplantation are stratified according to availability of donor HLA-identical related vs unrelated status and participating center Patients are randomized to receive an allogeneic transplantation or continue any salvage therapy
Patients who are not eligible for allogeneic transplantation receive hydroxyurea and cytarabine or high-dose chemotherapy with autologous stem cell rescue followed by interferon- or imatinib mesylate-based therapy
Patients over 45 years of age are further randomized to receive an age-adjusted standard conditioning regimen or reduced intensity preparative regimen mini transplantation prior to allogeneic transplantation
Patients are followed every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 1600 patients 400 per treatment arm will be accrued for this study within 4-5 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| EU-20248 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000271424 | REGISTRY | None | None |