Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002868
Status:
COMPLETED
Last Update Posted:
2023-06-22
First Post:
1999-11-01
Brief Title:
Interferon-alfa With or Without Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Newly Diagnosed Chronic Myelogenous Leukemia
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
PROSPECTIVE RANDOMISED STUDY TO COMPARE INTERFERON-ALPHA-n1 WELLFERON VS IDAC CHEMOTHERAPY AND AUTOGRAFTING FOLLOWED BY INTERFERON ALPHA-n1 WELLFERON IN PATIENTS WITH NEWLY DIAGNOSED CHRONIC PHASE CHRONIC MYELOID LEUKEMIA
Status:
COMPLETED
Status Verified Date:
2023-06
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 Interferon alfa may interfere with the growth of cancer cells Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die Combining interferon alfa with high-dose chemotherapy and peripheral stem cell 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 interferon alfa with or without peripheral stem cell transplantation in treating patients who have newly diagnosed chronic myelogenous leukemia in chronic phase
PURPOSE Randomized phase III trial to compare the effectiveness of interferon alfa with or without peripheral stem cell transplantation in treating patients who have newly diagnosed chronic myelogenous leukemia in chronic phase
Detailed Description:
OBJECTIVES I Compare overall survival in patients with chronic myelogenous leukemia in chronic phase treated with interferon alfa with or without cytarabine vs autologous peripheral blood stem cell transplantation followed by interferon alfa with or without cytarabine II Compare the time to blast transformation with these treatment regimens in these patients III Compare the number of these patients reverting to Philadelphia chromosome Ph negative hematopoiesis with these treatment regimens IV Compare the complete and major cytogenetic response rates in these patients at one year after receiving these treatment regimens and annually thereafter V Compare the hematological remission rate in these patients after receiving these treatment regimens VI Compare the duration of hematological remission and its impact on survival and blastic transformation in these patients after receiving these treatment regimens VII Compare the duration of Ph negative hemapoiesis and its impact on survival and blastic transformation in these patients after receiving these treatment regimens VIII Determine the number of these patients who fail one treatment regimen and can be rescued with the alternative IX Compare quality of life in these patients with these treatment regimens X Determine the number of these patients who tolerate these two regimens
OUTLINE This is a randomized multicenter study Patients are randomized to one of two treatment arms Arm I Patients undergo mobilization chemotherapy with a regimen of the centers choice such as either of the following Patients receive idarubicin IV over 10 minutes etoposide IV over 2 hours and cytarabine IV over 2 hours on days 1-3 and filgrastim G-CSF subcutaneously SC starting day 11 and continuing until blood counts recover OR Patients receive hydroxyurea IV daily until the neutrophil count drops below 1000mm3 or the platelet count drops below 20000mm3 followed by G-CSF SC for 3 consecutive days or until leukapheresis is complete Following mobilization therapy patients undergo leukapheresis within 6 months of diagnosis Patients then undergo cytoreductive therapy consisting of oral busulfan on days -5 to -2 Autologous peripheral blood stem cells are infused on day 0 Once blood counts have recovered patients receive interferon alfa SC 3 times a week for 8 weeks and then daily for at least a total of 6 months or until disease progression At the discretion of the treating physician patients may also receive cytarabine SC once a day for 10 days each month beginning 2 weeks after the interferon alfa therapy begins and continuing until complete cytogenetic response is achieved Arm II Patients receive interferon alfa SC 3 times a week for 4 weeks and then daily for 6 months If hematological remission is achieved after 6 months interferon treatment is continued for at least another 6 months or until disease progression At the discretion of the treating physician patients may also receive cytarabine as in arm I Quality of life is assessed at defined intervals Patients are followed for at least 2 years
PROJECTED ACCRUAL Approximately 744 patients will be accrued for this study within 5 years
OUTLINE This is a randomized multicenter study Patients are randomized to one of two treatment arms Arm I Patients undergo mobilization chemotherapy with a regimen of the centers choice such as either of the following Patients receive idarubicin IV over 10 minutes etoposide IV over 2 hours and cytarabine IV over 2 hours on days 1-3 and filgrastim G-CSF subcutaneously SC starting day 11 and continuing until blood counts recover OR Patients receive hydroxyurea IV daily until the neutrophil count drops below 1000mm3 or the platelet count drops below 20000mm3 followed by G-CSF SC for 3 consecutive days or until leukapheresis is complete Following mobilization therapy patients undergo leukapheresis within 6 months of diagnosis Patients then undergo cytoreductive therapy consisting of oral busulfan on days -5 to -2 Autologous peripheral blood stem cells are infused on day 0 Once blood counts have recovered patients receive interferon alfa SC 3 times a week for 8 weeks and then daily for at least a total of 6 months or until disease progression At the discretion of the treating physician patients may also receive cytarabine SC once a day for 10 days each month beginning 2 weeks after the interferon alfa therapy begins and continuing until complete cytogenetic response is achieved Arm II Patients receive interferon alfa SC 3 times a week for 4 weeks and then daily for 6 months If hematological remission is achieved after 6 months interferon treatment is continued for at least another 6 months or until disease progression At the discretion of the treating physician patients may also receive cytarabine as in arm I Quality of life is assessed at defined intervals Patients are followed for at least 2 years
PROJECTED ACCRUAL Approximately 744 patients will be accrued for this study within 5 years
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 |
|---|---|---|---|
| EU-96029 | None | None | None |
| MRC-LEUK-CML-2000 | None | None | None |
| ECOG-E7995 | None | None | None |
| MRC-LEUK-CML-IV | None | None | None |
| MRC-LEUK-CML-IVa | None | None | None |