Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00053196
Status:
COMPLETED
Last Update Posted:
2016-07-01
First Post:
2003-01-27
Brief Title:
Donor Stem Cell Transplant in Treating Patients With Relapsed Hematologic Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Non-Myeloablative Allogeneic Hematopoietic Cell Transplantation For Patients With Disease Relapse Or Myelodysplasia After Prior Autologous Transplantation
Status:
COMPLETED
Status Verified Date:
2016-06
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 fludarabine and busulfan 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 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 immunosuppressive therapy after the transplant may stop this from happening
PURPOSE This phase II trial is studying how well donor bone marrow or peripheral stem cell transplant works in treating patients with relapsed hematologic cancer after treatment with chemotherapy and autologous stem cell transplant
PURPOSE This phase II trial is studying how well donor bone marrow or peripheral stem cell transplant works in treating patients with relapsed hematologic cancer after treatment with chemotherapy and autologous stem cell transplant
Detailed Description:
OBJECTIVES
Determine the feasibility of non-myeloablative allogeneic hematopoietic stem cell transplantation by demonstrating that the risk of treatment-related mortality during the first 6 months is an acceptable rate of less than 40 in patients with relapsed hematologic malignancies after prior high-dose chemotherapy and autologous stem cell transplantation
Determine the response rates disease-specific partial and complete response in patients treated with this regimen
Determine the 6-month and 12-month probabilities of response in patients treated with this regimen
Determine the distribution of time-to-progression in patients responding to this regimen
Determine the percent donor chimerism in patients treated with this regimen
Determine the risk of acute and chronic graft-vs-host disease in patients treated with this regimen
Determine the toxic effects of this regimen in these patients
Determine the disease-free and overall survival of patients treated with this regimen
OUTLINE This is an open-label study
Preparative Regimen Patients receive fludarabine IV over 30 minutes on days -7 to -3 and busulfan IV over 2 hours every 6 hours for a total of 8 doses on days -4 and -3
Graft vs Host Disease GVHD Prophylaxis Patients who have an HLA-identical donor receive oral or IV if unable to tolerate oral administration tacrolimus twice daily on days -1 to 90 followed by a taper until day 150 and methotrexate IV on days 1 3 and 6 Patients with a matched related or matched unrelated donor receive oral or IV if unable to tolerate oral administration tacrolimus twice daily on days -1 to 180 followed by a taper as tolerated methotrexate IV on days 1 3 6 and 11 oral mycophenolate mofetil twice daily on days -2 to 60 followed by a taper and rabbit anti-thymocyte globulin IV over 4-6 hours on days -4 to -1 for a total of 4 doses
NOTE Tacrolimus may be tapered on days 60-90 if donor chimerism of CD3 cells is less than 50 at day 60 or patient has progressive disease
Allogeneic Stem Cell Transplantation Patients undergo allogeneic bone marrow or peripheral blood stem cell transplantation on days 0 and 1 Patients then receive filgrastim G-CSF subcutaneously daily beginning on day 7 and continuing until blood counts recover
Donor Lymphocyte Infusion DLI After day 180 or day 210 for patients without an HLA-identical donor patients with stable or progressive disease and no active GVHD may receive up to 3 DLIs every 8 weeks
Patients are followed within 2-3 months every 3 months for 2 years and then every 6 months for 3 years
Determine the feasibility of non-myeloablative allogeneic hematopoietic stem cell transplantation by demonstrating that the risk of treatment-related mortality during the first 6 months is an acceptable rate of less than 40 in patients with relapsed hematologic malignancies after prior high-dose chemotherapy and autologous stem cell transplantation
Determine the response rates disease-specific partial and complete response in patients treated with this regimen
Determine the 6-month and 12-month probabilities of response in patients treated with this regimen
Determine the distribution of time-to-progression in patients responding to this regimen
Determine the percent donor chimerism in patients treated with this regimen
Determine the risk of acute and chronic graft-vs-host disease in patients treated with this regimen
Determine the toxic effects of this regimen in these patients
Determine the disease-free and overall survival of patients treated with this regimen
OUTLINE This is an open-label study
Preparative Regimen Patients receive fludarabine IV over 30 minutes on days -7 to -3 and busulfan IV over 2 hours every 6 hours for a total of 8 doses on days -4 and -3
Graft vs Host Disease GVHD Prophylaxis Patients who have an HLA-identical donor receive oral or IV if unable to tolerate oral administration tacrolimus twice daily on days -1 to 90 followed by a taper until day 150 and methotrexate IV on days 1 3 and 6 Patients with a matched related or matched unrelated donor receive oral or IV if unable to tolerate oral administration tacrolimus twice daily on days -1 to 180 followed by a taper as tolerated methotrexate IV on days 1 3 6 and 11 oral mycophenolate mofetil twice daily on days -2 to 60 followed by a taper and rabbit anti-thymocyte globulin IV over 4-6 hours on days -4 to -1 for a total of 4 doses
NOTE Tacrolimus may be tapered on days 60-90 if donor chimerism of CD3 cells is less than 50 at day 60 or patient has progressive disease
Allogeneic Stem Cell Transplantation Patients undergo allogeneic bone marrow or peripheral blood stem cell transplantation on days 0 and 1 Patients then receive filgrastim G-CSF subcutaneously daily beginning on day 7 and continuing until blood counts recover
Donor Lymphocyte Infusion DLI After day 180 or day 210 for patients without an HLA-identical donor patients with stable or progressive disease and no active GVHD may receive up to 3 DLIs every 8 weeks
Patients are followed within 2-3 months every 3 months for 2 years and then every 6 months for 3 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 |
|---|---|---|---|
| CDR0000269301 | REGISTRY | NCI Physician Data Query | httpsreporternihgovquickSearchU10CA031946 |
| U10CA031946 | NIH | None | None |
| CALGB-100002 | None | None | None |