Ignite Creation Date:
2024-05-04 @ 6:49 PM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006252
Status:
COMPLETED
Last Update Posted:
2016-07-18
First Post:
2000-09-11
Brief Title:
Fludarabine and Cyclophosphamide Followed by Peripheral Stem Cell Transplant in Treating Patients With Leukemia or Lymphoma
Sponsor:
Cancer and Leukemia Group B
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Minimal Ablation and Cellular Immune Therapy of Chronic Lymphocytic Leukemia Prolymphocytic Leukemia Low-Grade Non-Hodgkins Lymphoma and Mantle Cell Lymphoma With Allogeneic Donor Stem Cells
Status:
COMPLETED
Status Verified Date:
2016-07
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 drugs such as fludarabine and cyclophosphamide before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells It also helps stop the patients immune system from rejecting the donors stem cells 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
PURPOSE This phase II trial is studying how well fludarabine and cyclophosphamide followed by peripheral stem cell transplant works in treating patients with leukemia or lymphoma
PURPOSE This phase II trial is studying how well fludarabine and cyclophosphamide followed by peripheral stem cell transplant works in treating patients with leukemia or lymphoma
Detailed Description:
OBJECTIVES
Determine the feasibility of fludarabine and cyclophosphamide followed by allogeneic peripheral blood stem cell transplantation in terms of 6-month treatment-related mortality in patients with chronic lymphocytic leukemia prolymphocytic leukemia low-grade non-Hodgkins lymphoma or mantle cell lymphoma
Determine the 6-month and 12-month probabilities of response in patients treated with this regimen
Determine the time to disease progression in patients responding to this regimen
Determine the percentage of donor chimerism achieved in patients treated with this regimen
Determine the risk of acute and chronic graft-versus-host disease in patients treated with this regimen
Determine the toxic effects of this regimen in these patients
Determine the overall survival and disease-free survival of patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive fludarabine IV over 30 minutes on days -7 to -3 and cyclophosphamide IV over 1 to 2 hours on days -5 to -3 Patients undergo allogeneic peripheral blood stem cell transplantation on days 0-1 Patients then receive filgrastim G-CSF subcutaneously daily beginning on day 5 and continuing until blood counts recover
Patients with no signs of active graft-versus host disease and stable or progressive disease receive donor lymphocytes IV over 2 hours beginning after day 120 Patients may receive a total of 3 infusions at least 8 weeks apart if disease remains stable or progressive
Patients are followed every 3 months for 2 years and then every 6 months for 5 years
PROJECTED ACCRUAL A maximum of 45 patients will be accrued for this study
Determine the feasibility of fludarabine and cyclophosphamide followed by allogeneic peripheral blood stem cell transplantation in terms of 6-month treatment-related mortality in patients with chronic lymphocytic leukemia prolymphocytic leukemia low-grade non-Hodgkins lymphoma or mantle cell lymphoma
Determine the 6-month and 12-month probabilities of response in patients treated with this regimen
Determine the time to disease progression in patients responding to this regimen
Determine the percentage of donor chimerism achieved in patients treated with this regimen
Determine the risk of acute and chronic graft-versus-host disease in patients treated with this regimen
Determine the toxic effects of this regimen in these patients
Determine the overall survival and disease-free survival of patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive fludarabine IV over 30 minutes on days -7 to -3 and cyclophosphamide IV over 1 to 2 hours on days -5 to -3 Patients undergo allogeneic peripheral blood stem cell transplantation on days 0-1 Patients then receive filgrastim G-CSF subcutaneously daily beginning on day 5 and continuing until blood counts recover
Patients with no signs of active graft-versus host disease and stable or progressive disease receive donor lymphocytes IV over 2 hours beginning after day 120 Patients may receive a total of 3 infusions at least 8 weeks apart if disease remains stable or progressive
Patients are followed every 3 months for 2 years and then every 6 months for 5 years
PROJECTED ACCRUAL A maximum of 45 patients will be accrued for this study
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 |
|---|---|---|---|
| CALGB-109901 | None | None | None |
| U10CA031946 | NIH | None | None |
| CDR0000068185 | REGISTRY | NCI Physician Data Query | httpsreporternihgovquickSearchU10CA031946 |