Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00453206
Status:
COMPLETED
Last Update Posted:
2018-09-10
First Post:
2007-03-27
Brief Title:
Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer or Other Diseases
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
Reduced Intensity Allogeneic Hematopoietic Cell Transplantation for Patients With Hematological Diseases
Status:
COMPLETED
Status Verified Date:
2018-08
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 chemotherapy such as fludarabine busulfan and melphalan before a donor peripheral stem cell transplant or bone marrow transplant helps stop the growth of cancer or abnormal cells It also helps stop the patients immune system from rejecting the donors stem cells When the healthy stem cells from a donor are infused into the patient they may help the patients bone marrow make stem cells red blood cells white blood cells and platelets Sometimes the transplanted cells from a donor can make an immune response against the bodys normal cells Giving tacrolimus methotrexate mycophenolate mofetil and antithymocyte globulin before and after transplant may stop this from happening Once the donated stem cells begin working the patients immune system may see the remaining cancer or abnormal cells as not belonging in the patients body and destroy them graft-versus-tumor effect Giving an infusion of the donors white blood cells donor lymphocyte infusion may boost this effect
PURPOSE This phase II trial is studying how well donor stem cell transplant works in treating patients with hematologic cancer or other diseases
PURPOSE This phase II trial is studying how well donor stem cell transplant works in treating patients with hematologic cancer or other diseases
Detailed Description:
OBJECTIVES
Primary
Determine the feasibility ie risk of treatment-related mortality during the first 6 months after transplantation of administering reduced-intensity allogeneic hematopoietic stem cell transplantation to patients with hematologic cancer or other diseases
Secondary
Determine the response rate partial and complete response 6- and 12-month probabilities of response and time to progression in patients treated with this regimen
Determine the risk of acute and chronic graft-versus-host disease in patients treated with this regimen
Determine other toxicities of this regimen in these patients
Determine the overall survival and disease-free survival of patients treated with this regimen
Determine the impact of iron status on overall and disease-free survival
Determine the influence of quality of life at time of transplantation on overall survival
OUTLINE
Preparative regimen Patients receive fludarabine phosphate IV over 30 minutes on days -7 to -3 Patients also receive busulfan IV over 2 hours every 6 hours on days -4 and -3 or melphalan IV over 2 hours on day -3
Graft-versus-host disease GVHD prophylaxis Patients with matched related donors receive oral tacrolimus twice daily on days -1 to 90 followed by a taper until day 180 Patients also receive methotrexate IV on days 1 3 and 6 Patients with matched unrelated and 910 matched related donors receive oral tacrolimus twice daily on days -1 to 180 followed by a taper methotrexate IV on days 1 3 6 and 11 and oral mycophenolate mofetil twice daily on days -2 to 60 followed by a taper All patients also receive antithymocyte globulin IV over 4 to 6 hours once a day on days -4 to -1
Allogeneic stem cell transplantation Patients undergo allogeneic peripheral blood stem cell transplantation or bone marrow transplantation on day 0 Patients receive filgrastim G-CSF beginning on day 7 and continuing until blood counts recover
Lymphocyte infusion Patients with progressive or stable disease while off immunosuppression and no active GVHD may receive up to 3 donor lymphocyte infusions from the original donor at 8-week intervals beginning on day 180 or 210
Quality of life is assessed at baseline
After completion of study therapy patients are followed every 3 months for 2 years and then every 6 months for up to 3 years
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study
Primary
Determine the feasibility ie risk of treatment-related mortality during the first 6 months after transplantation of administering reduced-intensity allogeneic hematopoietic stem cell transplantation to patients with hematologic cancer or other diseases
Secondary
Determine the response rate partial and complete response 6- and 12-month probabilities of response and time to progression in patients treated with this regimen
Determine the risk of acute and chronic graft-versus-host disease in patients treated with this regimen
Determine other toxicities of this regimen in these patients
Determine the overall survival and disease-free survival of patients treated with this regimen
Determine the impact of iron status on overall and disease-free survival
Determine the influence of quality of life at time of transplantation on overall survival
OUTLINE
Preparative regimen Patients receive fludarabine phosphate IV over 30 minutes on days -7 to -3 Patients also receive busulfan IV over 2 hours every 6 hours on days -4 and -3 or melphalan IV over 2 hours on day -3
Graft-versus-host disease GVHD prophylaxis Patients with matched related donors receive oral tacrolimus twice daily on days -1 to 90 followed by a taper until day 180 Patients also receive methotrexate IV on days 1 3 and 6 Patients with matched unrelated and 910 matched related donors receive oral tacrolimus twice daily on days -1 to 180 followed by a taper methotrexate IV on days 1 3 6 and 11 and oral mycophenolate mofetil twice daily on days -2 to 60 followed by a taper All patients also receive antithymocyte globulin IV over 4 to 6 hours once a day on days -4 to -1
Allogeneic stem cell transplantation Patients undergo allogeneic peripheral blood stem cell transplantation or bone marrow transplantation on day 0 Patients receive filgrastim G-CSF beginning on day 7 and continuing until blood counts recover
Lymphocyte infusion Patients with progressive or stable disease while off immunosuppression and no active GVHD may receive up to 3 donor lymphocyte infusions from the original donor at 8-week intervals beginning on day 180 or 210
Quality of life is assessed at baseline
After completion of study therapy patients are followed every 3 months for 2 years and then every 6 months for up to 3 years
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| IRB00001366 | OTHER | WFUHS IRB | None |
| CCCWFU-29506 | OTHER | None | None |