Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00027560
Status:
COMPLETED
Last Update Posted:
2013-01-07
First Post:
2001-12-07
Brief Title:
Melphalan Fludarabine and Alemtuzumab Followed by Peripheral Stem Cell Transplant in Treating Patients With Hematologic Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Phase II Trial Of Non-Myeloablative Regimen Combining Melphalan Fludarabine And Anti-CD52 Monoclonal Antibody CAMPATH-1H Followed By An Unmodified Hematopoietic Cell Transplant From An HLA Compatible Related Or Unrelated Donor For Treatment Of Lymphohematopoietic Malignancies
Status:
COMPLETED
Status Verified Date:
2012-12
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 low doses of chemotherapy such as melphalan and fludarabine and a monoclonal antibody such as alemtuzumab before a donor bone marrow or 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 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 after the transplant may stop this from happening
PURPOSE This phase II trial is studying how well fludarabine melphalan alemtuzumab and peripheral stem cell transplant work in treating patients with hematologic cancer
PURPOSE This phase II trial is studying how well fludarabine melphalan alemtuzumab and peripheral stem cell transplant work in treating patients with hematologic cancer
Detailed Description:
OBJECTIVES
Overall survival-12 months
Overall survival-24 months
Acute Graft-versus-Host Disease Matched Related patients-up to 4 months post transplant
Acute Graft-versus-Host Disease Unrelated and Mismatched related patients- up to 4 months post transplant
Chronic Graft-versus-Host Disease Matched Related patients- up to 2 years post transplant
Chronic Graft-versus-host disease Unrelated and Mismatched related patients- up to 2 years post transplant
OUTLINE Patients are stratified according to donor type HLA-matched related vs HLA-matched unrelated single HLA-allele disparate related or unmatched HLA-mismatched related or matched unrelated donor stratum closed to accrual as of 11106
Patients receive a nonmyeloablative regimen comprising alemtuzumab IV over 8 hours on days -8 to -5 fludarabine IV over 30 minutes on days -8 to -4 and melphalan IV over 30 minutes on days -3 and -2 Allogeneic peripheral blood stem cells or bone marrow is infused on day 0
Patients receive graft-versus host disease prophylaxis comprising cyclosporine IV every 12 hours beginning on day -1 and continuing orally as tolerated until day 100
Patients are followed every 6 weeks for 6 months every 3 months for 6 months every 3-6 months for 1 year and then annually thereafter or as clinically indicated
PROJECTED ACCRUAL A maximum of 50 patients 25 HLA-matched related and 25 HLA-mismatched related or matched unrelated will be accrued for this study within 2 years HLA-mismatched related or matched unrelated donor stratum closed to accrual as of 11106
Overall survival-12 months
Overall survival-24 months
Acute Graft-versus-Host Disease Matched Related patients-up to 4 months post transplant
Acute Graft-versus-Host Disease Unrelated and Mismatched related patients- up to 4 months post transplant
Chronic Graft-versus-Host Disease Matched Related patients- up to 2 years post transplant
Chronic Graft-versus-host disease Unrelated and Mismatched related patients- up to 2 years post transplant
OUTLINE Patients are stratified according to donor type HLA-matched related vs HLA-matched unrelated single HLA-allele disparate related or unmatched HLA-mismatched related or matched unrelated donor stratum closed to accrual as of 11106
Patients receive a nonmyeloablative regimen comprising alemtuzumab IV over 8 hours on days -8 to -5 fludarabine IV over 30 minutes on days -8 to -4 and melphalan IV over 30 minutes on days -3 and -2 Allogeneic peripheral blood stem cells or bone marrow is infused on day 0
Patients receive graft-versus host disease prophylaxis comprising cyclosporine IV every 12 hours beginning on day -1 and continuing orally as tolerated until day 100
Patients are followed every 6 weeks for 6 months every 3 months for 6 months every 3-6 months for 1 year and then annually thereafter or as clinically indicated
PROJECTED ACCRUAL A maximum of 50 patients 25 HLA-matched related and 25 HLA-mismatched related or matched unrelated will be accrued for this study within 2 years HLA-mismatched related or matched unrelated donor stratum closed to accrual as of 11106
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-G01-2028 | None | None | None |
| MSKCC-01092 | None | None | None |