Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002761
Status:
WITHDRAWN
Last Update Posted:
2012-11-19
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myelogenous Leukemia
Sponsor:
Columbia University
Organization:
Columbia University
Study Overview
Official Title:
CAMP-010 PHASE III STUDY OF IN VIVO PURGING FOLLOWED BY HIGH DOSE CHEMOTHERAPY AUTOLOGOUS HEMATOPOIETIC STEM CELL INFUSION AND IMMUNOTHERAPY IN PATIENTS WITH CHRONIC MYELOID LEUKEMIA
Status:
WITHDRAWN
Status Verified Date:
2012-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI left institution
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 peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells
PURPOSE Phase III trial to study the effectiveness of combination chemotherapy followed by peripheral stem cell transplantation in treating patients with chronic myelogenous leukemia
PURPOSE Phase III trial to study the effectiveness of combination chemotherapy followed by peripheral stem cell transplantation in treating patients with chronic myelogenous leukemia
Detailed Description:
OBJECTIVES I Determine whether intensive idarubicin and cytarabine leads to adequate harvest of Philadelphia chromosome-negative peripheral blood stem cells PBSC in patients with chronic myelogenous leukemia in chronic phase II Determine the toxicity of this intensive regimen in these patients III Determine the graft-versus-leukemia effect induced in these patients by cyclosporine and interferon gamma post-PBSC transplantation IV Determine the transformation-free and overall survival in patients treated with a high-dose conditioning regimen comprising busulfan and cyclophosphamide followed by PBSC transplantation plus immunotherapy
OUTLINE Patients receive idarubicin IV and cytarabine IV over 2 hours on days 1-3 When blood counts recover Philadelphia chromosome negative peripheral blood stem cells PBSC are harvested Filgrastim G-CSF is administered subcutaneously SC beginning 24 hours after completion of cytarabine infusion and continuing until blood counts have recovered for 3 consecutive days after harvest of PBSC Patients with more than 5 blasts in marrow or any peripheral blasts interferon resistance interferon intolerance with poor prognosis and clonal evolution proceed to conditioning followed by PBSC transplantation Patients receive conditioning comprising oral busulfan every 6 hrs on days -8 to -5 and cyclophosphamide IV over 2 hours on days -4 and -3 PBSC are reinfused on day 0 Patients receive graft versus leukemia induction comprising cyclosporine IV over 4 hours every 12 hours on days 0-28 and interferon gamma SC beginning on day 7 and continuing every other day through day 28 Patients are followed every 3 months for 1 year and then annually for 5 years
PROJECTED ACCRUAL A total of 15-43 patients will be accrued for this study within 4-8 years
OUTLINE Patients receive idarubicin IV and cytarabine IV over 2 hours on days 1-3 When blood counts recover Philadelphia chromosome negative peripheral blood stem cells PBSC are harvested Filgrastim G-CSF is administered subcutaneously SC beginning 24 hours after completion of cytarabine infusion and continuing until blood counts have recovered for 3 consecutive days after harvest of PBSC Patients with more than 5 blasts in marrow or any peripheral blasts interferon resistance interferon intolerance with poor prognosis and clonal evolution proceed to conditioning followed by PBSC transplantation Patients receive conditioning comprising oral busulfan every 6 hrs on days -8 to -5 and cyclophosphamide IV over 2 hours on days -4 and -3 PBSC are reinfused on day 0 Patients receive graft versus leukemia induction comprising cyclosporine IV over 4 hours every 12 hours on days 0-28 and interferon gamma SC beginning on day 7 and continuing every other day through day 28 Patients are followed every 3 months for 1 year and then annually for 5 years
PROJECTED ACCRUAL A total of 15-43 patients will be accrued for this study within 4-8 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 |
|---|---|---|---|
| NCI-V96-0873 | None | None | None |
| CU-CAMP-10 | None | None | None |