Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00036738
Status:
COMPLETED
Last Update Posted:
2020-01-29
First Post:
2002-05-13
Brief Title:
Fludarabine Phosphate and Total-Body Irradiation Followed by Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia That Has Responded to Treatment With Imatinib Mesylate Dasatinib or Nilotinib
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
Allogeneic Nonmyeloablative Hematopoietic Stem Cell Transplant for Patients With BCR-ABL Tyrosine Kinase Inhibitor Responsive Ph Acute Leukemia A Multi-center Trial
Status:
COMPLETED
Status Verified Date:
2019-12
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:
This phase II trial is studying how well fludarabine phosphate and total-body irradiation followed by donor peripheral blood stem cell transplant work in treating patients with acute lymphoblastic leukemia or chronic myelogenous leukemia that has responded to previous treatment with imatinib mesylate dasatinib or nilotinib Giving low doses of chemotherapy such as fludarabine phosphate and total-body irradiation TBI before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells It may also stop 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 Giving an infusion of the donors T cells donor lymphocyte infusion after the transplant may help increase this effect Sometimes the transplanted cells from a donor can also make an immune response against the bodys normal cells Giving mycophenolate mofetil and cyclosporine after the transplant may stop this from happening
Detailed Description:
PRIMARY OBJECTIVES
I To determine whether the rate of leukemia relapse can be decreased for patients with chronic myelogenous leukemia in blast crisis CML-BC and Philadelphia chromosome positive acute lymphoblastic leukemia Ph ALL responsive to imatinib mesylate or either dasatinib or nilotinib for patients who have imatinib-resistant disease or who are intolerant of imatinib followed by nonmyeloablative hematopoietic stem cell transplantation HSCT compared to historical controls given high-dose conventional allogeneic HSCT or chemotherapy
II To determine whether the rate of transplantation-related mortality TRM can be decreased for patients with CML-BC and Ph ALL responsive to imatinib mesylate or dasatinib or nilotinib followed by nonmyeloablative HSCT compared to historical controls given high-dose conventional allogeneic HSCT or chemotherapy
SECONDARY OBJECTIVES
I To evaluate whether donor lymphocyte infusion DLI can be safely used in patients with mixed or full donor chimerism as preemptive therapy to eliminate minimal residual disease
OUTLINE
INDUCTION THERAPY Patients continue to receive imatinib mesylate orally PO dasatinib PO or nilotinib PO once or twice daily until day -2 and resume on day 14 or when blood counts recover after peripheral blood stem cell PBSC transplantation
NONMYELOABLATIVE CONDITIONING Patients receive fludarabine intravenously IV on days -4 to -2 and undergo TBI on day 0
TRANSPLANTATION Patients undergo allogeneic PBSC transplantation on day 0
GRAFT-VERSUS-HOST-DISEASE GVHD PROPHYLAXIS Patients receive mycophenolate mofetil MMF PO every 12 hours on days 0-27 related donor recipients or every 8 hours on days 0-96 with taper on day 40 unrelated donor recipients Patients also receive cyclosporine IV or PO every 12 hours on days -3 to 56 followed by taper on days 57-180 related donor recipients or on days -3 to 100 followed by taper on days 101-177 unrelated donor recipients
DONOR LYMPHOCYTE INFUSION Patients with persistent disease and no GVHD after stopping GVHD prophylaxis receive donor lymphocyte infusion IV over 30 minutes once every 28 days for 3 doses
Treatment continues in the absence of disease progression or unacceptable toxicity
Patients are followed up periodically for 2 years and then annually thereafter for 5 years
I To determine whether the rate of leukemia relapse can be decreased for patients with chronic myelogenous leukemia in blast crisis CML-BC and Philadelphia chromosome positive acute lymphoblastic leukemia Ph ALL responsive to imatinib mesylate or either dasatinib or nilotinib for patients who have imatinib-resistant disease or who are intolerant of imatinib followed by nonmyeloablative hematopoietic stem cell transplantation HSCT compared to historical controls given high-dose conventional allogeneic HSCT or chemotherapy
II To determine whether the rate of transplantation-related mortality TRM can be decreased for patients with CML-BC and Ph ALL responsive to imatinib mesylate or dasatinib or nilotinib followed by nonmyeloablative HSCT compared to historical controls given high-dose conventional allogeneic HSCT or chemotherapy
SECONDARY OBJECTIVES
I To evaluate whether donor lymphocyte infusion DLI can be safely used in patients with mixed or full donor chimerism as preemptive therapy to eliminate minimal residual disease
OUTLINE
INDUCTION THERAPY Patients continue to receive imatinib mesylate orally PO dasatinib PO or nilotinib PO once or twice daily until day -2 and resume on day 14 or when blood counts recover after peripheral blood stem cell PBSC transplantation
NONMYELOABLATIVE CONDITIONING Patients receive fludarabine intravenously IV on days -4 to -2 and undergo TBI on day 0
TRANSPLANTATION Patients undergo allogeneic PBSC transplantation on day 0
GRAFT-VERSUS-HOST-DISEASE GVHD PROPHYLAXIS Patients receive mycophenolate mofetil MMF PO every 12 hours on days 0-27 related donor recipients or every 8 hours on days 0-96 with taper on day 40 unrelated donor recipients Patients also receive cyclosporine IV or PO every 12 hours on days -3 to 56 followed by taper on days 57-180 related donor recipients or on days -3 to 100 followed by taper on days 101-177 unrelated donor recipients
DONOR LYMPHOCYTE INFUSION Patients with persistent disease and no GVHD after stopping GVHD prophylaxis receive donor lymphocyte infusion IV over 30 minutes once every 28 days for 3 doses
Treatment continues in the absence of disease progression or unacceptable toxicity
Patients are followed up periodically for 2 years and then annually thereafter for 5 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 |
|---|---|---|---|
| P30CA015704 | NIH | Fred HutchUniversity of Washington Cancer Consortium | httpsreporternihgovquickSearchP30CA015704 |
| NCI-2010-00131 | REGISTRY | None | None |
| 158100 | OTHER | None | None |
| P01CA078902 | NIH | None | None |