Ignite Creation Date:
2024-05-05 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00041288
Status:
TERMINATED
Last Update Posted:
2020-04-10
First Post:
2002-07-08
Brief Title:
Study Of Two Non-Myeloablative Stem Cell Transplant Strategies For Low-Grade Lymphoma And CLL
Sponsor:
University of Texas Southwestern Medical Center
Organization:
University of Texas Southwestern Medical Center
Study Overview
Official Title:
A Phase II Multicenter Randomized Study Of Two Non-Myeloablative Stem Cell Transplant Strategies For Low-Grade Lymphoma And Chronic Lymphocytic Leukemia CLL
Status:
TERMINATED
Status Verified Date:
2020-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Poor accrual and difficulty with multicenter logistics
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 tumor cells from dividing so they stop growing or die Radiation therapy uses high-energy x-rays to damage tumor cells Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy Sometimes the transplanted cells are rejected by the bodys normal tissues Cyclosporine mycophenolate mofetil methotrexate and tacrolimus may prevent this from happening
PURPOSE Randomized phase II trial to compare the effectiveness of fludarabine plus total-body irradiation with that of combination chemotherapy followed by donor peripheral stem cell transplantation in treating patients who have relapsed non-Hodgkins lymphoma or chronic lymphocytic leukemia
PURPOSE Randomized phase II trial to compare the effectiveness of fludarabine plus total-body irradiation with that of combination chemotherapy followed by donor peripheral stem cell transplantation in treating patients who have relapsed non-Hodgkins lymphoma or chronic lymphocytic leukemia
Detailed Description:
OBJECTIVES
Compare the 1-year overall survival rate of patients with relapsed low-grade non-Hodgkins lymphoma or chronic lymphocytic leukemia treated with fludarabine and total body irradiation vs cyclophosphamide and fludarabine followed by allogeneic peripheral blood stem cell transplantation and donor lymphocyte infusions
Compare the toxic effects of these regimens in these patients
Compare the incidence and severity of acute and chronic graft-versus-host disease in patients treated with these regimens
Compare the 1-year treatment-related mortality and infectious complications in patients treated with these regimens
Compare the efficacy of these treatment regimens in terms of 1-year disease-free survival of these patients
Compare the quality of life of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to disease age less than 55 vs over 55 and participating transplantation center Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive fludarabine IV on days -4 to -2 Patients undergo total body irradiation followed by allogeneic peripheral blood stem cell transplantation PBSCT on day 0 Patients receive graft-versus-host disease GVHD prophylaxis comprising oral cyclosporine twice daily on days -2 to 90 followed by a taper on days 90-150 and oral mycophenolate mofetil twice daily on days 0-28
Arm II Patients receive fludarabine IV on days -6 to -2 and cyclophosphamide IV on days -3 to -2 Patients undergo PBSCT on day 0 Patients receive GVHD prophylaxis comprising methotrexate IV on days 1 3 6 and 11 and tacrolimus IV continuously and then orally on days -2 to 90 followed by a taper on days 90-150
At approximately day 180 patients with persistent disease evidence of T-cell chimerism and no GVHD may receive up to 3 donor lymphocyte infusions administered every 1-2 months
Quality of life is assessed at baseline 1 month every 3 months for 1 year and then every 6 months for 1 year
Patients are followed at 1 month every 3 months for 1 year and then annually for 2 years
PROJECTED ACCRUAL A total of 100 patients 50 per treatment arm will be accrued for this study
Compare the 1-year overall survival rate of patients with relapsed low-grade non-Hodgkins lymphoma or chronic lymphocytic leukemia treated with fludarabine and total body irradiation vs cyclophosphamide and fludarabine followed by allogeneic peripheral blood stem cell transplantation and donor lymphocyte infusions
Compare the toxic effects of these regimens in these patients
Compare the incidence and severity of acute and chronic graft-versus-host disease in patients treated with these regimens
Compare the 1-year treatment-related mortality and infectious complications in patients treated with these regimens
Compare the efficacy of these treatment regimens in terms of 1-year disease-free survival of these patients
Compare the quality of life of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to disease age less than 55 vs over 55 and participating transplantation center Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive fludarabine IV on days -4 to -2 Patients undergo total body irradiation followed by allogeneic peripheral blood stem cell transplantation PBSCT on day 0 Patients receive graft-versus-host disease GVHD prophylaxis comprising oral cyclosporine twice daily on days -2 to 90 followed by a taper on days 90-150 and oral mycophenolate mofetil twice daily on days 0-28
Arm II Patients receive fludarabine IV on days -6 to -2 and cyclophosphamide IV on days -3 to -2 Patients undergo PBSCT on day 0 Patients receive GVHD prophylaxis comprising methotrexate IV on days 1 3 6 and 11 and tacrolimus IV continuously and then orally on days -2 to 90 followed by a taper on days 90-150
At approximately day 180 patients with persistent disease evidence of T-cell chimerism and no GVHD may receive up to 3 donor lymphocyte infusions administered every 1-2 months
Quality of life is assessed at baseline 1 month every 3 months for 1 year and then every 6 months for 1 year
Patients are followed at 1 month every 3 months for 1 year and then annually for 2 years
PROJECTED ACCRUAL A total of 100 patients 50 per treatment arm 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 |
|---|---|---|---|
| NCI-V02-1706 | None | None | None |
| UTSMC-0501228 | None | None | None |
| AMGEN-UTSMC-0501228 | None | None | None |
| IBMTR-SC-00-021 | None | None | None |
| ROCHE-UTSMC-0501228 | None | None | None |
| SPRI-UTSMC-0501228 | None | None | None |