Ignite Creation Date:
2024-05-05 @ 1:18 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006747
Status:
COMPLETED
Last Update Posted:
2016-07-19
First Post:
2000-12-06
Brief Title:
Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Mantle Cell Lymphoma
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Allogeneic Stem Cell Transplantation for Mantle Cell Lymphoma
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 Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die Combining more than one drug may kill more cancer cells Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill cancer cells
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy followed by donor peripheral stem cell transplantation in treating patients who have mantle cell lymphoma
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy followed by donor peripheral stem cell transplantation in treating patients who have mantle cell lymphoma
Detailed Description:
OBJECTIVES
Determine the long term disease-free survival of patients with mantle cell lymphoma treated with etoposide carmustine melphalan and cytarabine followed by allogeneic peripheral blood stem cell transplantation
Determine the incidence of molecular remissions in these patients treated with this regimen
Correlate the persistence of minimal residual disease with clinical outcome in these patients treated with this regimen
Determine the effect of donor lymphocytes in patients with progressive disease after treatment with this regimen
OUTLINE This is a multicenter study
Patients receive carmustine IV over 2 hours on day -6 etoposide IV over 3 hours and cytarabine IV over 1 hour every 12 hours on days -5 to -2 for a total of 8 doses and melphalan IV over 20-30 minutes on day -1 Patients undergo allogeneic peripheral blood stem cell PBSC transplantation on day 0 Patients also receive tacrolimus IV continuously over 24 hours beginning on day -2 and then orally twice daily until day 120 and methotrexate IV over 30 minutes on days 1 3 and 6 as graft-versus-host disease GVHD prophylaxis Patients receive sargramostim GM-CSF IV or subcutaneously daily beginning on day 7 and continuing until blood counts recover
Patients with no active GVHD who have persistent disease on day 150 or progressive disease at any time after PBSC transplantation receive donor lymphocytes IV over 2 hours Patients may receive additional donor lymphocytes at least 8 weeks later if disease persists
Patients are followed at 6 and 12 months posttransplantation and then annually for 4 years
Determine the long term disease-free survival of patients with mantle cell lymphoma treated with etoposide carmustine melphalan and cytarabine followed by allogeneic peripheral blood stem cell transplantation
Determine the incidence of molecular remissions in these patients treated with this regimen
Correlate the persistence of minimal residual disease with clinical outcome in these patients treated with this regimen
Determine the effect of donor lymphocytes in patients with progressive disease after treatment with this regimen
OUTLINE This is a multicenter study
Patients receive carmustine IV over 2 hours on day -6 etoposide IV over 3 hours and cytarabine IV over 1 hour every 12 hours on days -5 to -2 for a total of 8 doses and melphalan IV over 20-30 minutes on day -1 Patients undergo allogeneic peripheral blood stem cell PBSC transplantation on day 0 Patients also receive tacrolimus IV continuously over 24 hours beginning on day -2 and then orally twice daily until day 120 and methotrexate IV over 30 minutes on days 1 3 and 6 as graft-versus-host disease GVHD prophylaxis Patients receive sargramostim GM-CSF IV or subcutaneously daily beginning on day 7 and continuing until blood counts recover
Patients with no active GVHD who have persistent disease on day 150 or progressive disease at any time after PBSC transplantation receive donor lymphocytes IV over 2 hours Patients may receive additional donor lymphocytes at least 8 weeks later if disease persists
Patients are followed at 6 and 12 months posttransplantation and then annually for 4 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 |
|---|---|---|---|
| CDR0000068324 | REGISTRY | NCI Physician Data Query | httpsreporternihgovquickSearchU10CA031946 |
| CLB-59908 | None | None | None |
| U10CA031946 | NIH | None | None |