Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00085449
Status:
WITHDRAWN
Last Update Posted:
2019-11-27
First Post:
2004-06-10
Brief Title:
Alemtuzumab Plus Fludarabine and Melphalan With or Without Cyclosporine Mycophenolate Mofetil and Low-Dose Total-Body Irradiation Therapy Followed by Donor Peripheral Stem Cell Transplant in Treating Patients With Hematologic Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
A Trial of Reduced Intensity Conditioning and Transplantation of Haplotype Mismatched and KIR Class I Epitope-Mismatched Highly Purified CD34 Cells
Status:
WITHDRAWN
Status Verified Date:
2019-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Funding cut no patients enrolled
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Giving low doses of chemotherapy monoclonal antibodies and radiation therapy before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells It also stops the patients immune system from rejecting the donors stem cells when they do not exactly match the patients blood The donated stem cells may replace the patients immune system and help destroy any remaining cancer cells graft-versus-tumor effect Sometimes the transplanted cells from a donor can also make an immune response against the bodys normal cells Giving cyclosporine and mycophenolate mofetil before transplant may stop this from happening
PURPOSE This phase III trial is studying the side effects of alemtuzumab fludarabine and melphalan with or without cyclosporine mycophenolate mofetil and total-body irradiation before donor peripheral blood stem cell transplant and to see how well they work in treating patients with relapsed or refractory hematologic cancer
PURPOSE This phase III trial is studying the side effects of alemtuzumab fludarabine and melphalan with or without cyclosporine mycophenolate mofetil and total-body irradiation before donor peripheral blood stem cell transplant and to see how well they work in treating patients with relapsed or refractory hematologic cancer
Detailed Description:
OBJECTIVES
Determine the ability of a reduced-intensity conditioning regimen comprising alemtuzumab fludarabine and melphalan with or without cyclosporine mycophenolate mofetil and low-dose total body radiotherapy followed by haplotype-mismatched KIR class I epitope-mismatched CD34-positive allogeneic peripheral blood stem cell transplantation to facilitate engraftment by day 35 post-transplantation in at least 85 of patients with relapsed refractory or poor-risk hematological malignancies
Determine the risk of graft-versus-host-disease in patients treated with these regimens
Determine preliminarily the efficacy of these regimens in terms of progression-free survival in these patients
Correlate outcomes engraftment and progression-free survival with the number of detectable alloreactive natural killer cell clones before transplantation and after engraftment in patients treated with these regimens
Determine immune reconstitution in patients treated with these regimens
OUTLINE This is a multicenter pilot study Patients are initially treated with conditioning regimen A If adequate donor engraftment is not achieved subsequent patients are treated with conditioning regimen B
Conditioning regimen A Patients receive alemtuzumab IV over 2 hours on days -14 to -12 fludarabine IV over 30 minutes on days -7 to -3 and melphalan IV over 20-30 minutes on day -2
Conditioning regimen B Patients receive oral or IV cyclosporine twice daily and oral or IV mycophenolate mofetil twice daily on days -15 to 0 Patients also receive alemtuzumab fludarabine and melphalan as in conditioning regimen A Patients undergo low-dose total body irradiation twice daily on days -2 and -1
All patients undergo allogeneic T-cell-depleted CD34-positive peripheral blood stem cell transplantation on day 0 Patients receive sargramostim GM-CSF subcutaneously beginning on day 1 and continuing until blood counts recover
Patients are followed every 3 months for 1 year and then every 6 months for 5 years
PROJECTED ACCRUAL A total of 14-56 patients 14-28 per regimen will be accrued for this study
Determine the ability of a reduced-intensity conditioning regimen comprising alemtuzumab fludarabine and melphalan with or without cyclosporine mycophenolate mofetil and low-dose total body radiotherapy followed by haplotype-mismatched KIR class I epitope-mismatched CD34-positive allogeneic peripheral blood stem cell transplantation to facilitate engraftment by day 35 post-transplantation in at least 85 of patients with relapsed refractory or poor-risk hematological malignancies
Determine the risk of graft-versus-host-disease in patients treated with these regimens
Determine preliminarily the efficacy of these regimens in terms of progression-free survival in these patients
Correlate outcomes engraftment and progression-free survival with the number of detectable alloreactive natural killer cell clones before transplantation and after engraftment in patients treated with these regimens
Determine immune reconstitution in patients treated with these regimens
OUTLINE This is a multicenter pilot study Patients are initially treated with conditioning regimen A If adequate donor engraftment is not achieved subsequent patients are treated with conditioning regimen B
Conditioning regimen A Patients receive alemtuzumab IV over 2 hours on days -14 to -12 fludarabine IV over 30 minutes on days -7 to -3 and melphalan IV over 20-30 minutes on day -2
Conditioning regimen B Patients receive oral or IV cyclosporine twice daily and oral or IV mycophenolate mofetil twice daily on days -15 to 0 Patients also receive alemtuzumab fludarabine and melphalan as in conditioning regimen A Patients undergo low-dose total body irradiation twice daily on days -2 and -1
All patients undergo allogeneic T-cell-depleted CD34-positive peripheral blood stem cell transplantation on day 0 Patients receive sargramostim GM-CSF subcutaneously beginning on day 1 and continuing until blood counts recover
Patients are followed every 3 months for 1 year and then every 6 months for 5 years
PROJECTED ACCRUAL A total of 14-56 patients 14-28 per regimen 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 |
|---|---|---|---|
| CDR0000370797 | REGISTRY | NCI Physician Data Query | None |
| CALGB-100102 | None | None | None |