Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00008307
Status:
UNKNOWN
Last Update Posted:
2014-01-06
First Post:
2001-01-06
Brief Title:
Combination Chemotherapy Followed by Donor Bone Marrow Transplant or Peripheral Stem Cell Transplant in Treating Patients With Hematologic Cancer or Genetic Disorders
Sponsor:
Herbert Irving Comprehensive Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Non-Ablative Chemotherapeutic Conditioning Before Allogeneic Stem Cell Transplantation
Status:
UNKNOWN
Status Verified Date:
2006-04
Last Known Status:
ACTIVE_NOT_RECRUITING
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 drugs such as fludarabine and melphalan before a donor bone marrow transplant or peripheral blood stem cell transplant helps stop the patients immune system from rejecting the donors stem cells and helps stop the growth of cancer or abnormal 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
PURPOSE This phase II trial is studying how well giving combination chemotherapy followed by donor bone marrow transplant or peripheral stem cell transplant works in treating patients with hematologic cancer or genetic disorders
PURPOSE This phase II trial is studying how well giving combination chemotherapy followed by donor bone marrow transplant or peripheral stem cell transplant works in treating patients with hematologic cancer or genetic disorders
Detailed Description:
OBJECTIVES
Determine the hematopoietic recovery in patients with hematologic malignancies or genetic disorders treated with fludarabine and melphalan followed by allogeneic or syngeneic bone marrow or peripheral blood stem cell transplantation
Determine the chemotherapeutic toxicity of this regimen in these patients
Determine the relapse and survival of patients treated with this regimen
Determine the incidence of graft-versus-host disease in patients treated with this regimen
OUTLINE Patients receive fludarabine IV on days -6 to -2 and melphalan IV on days -3 and -2 Patients with a non-HLA-identical family member may also receive anti-thymocyte globulin on days -4 to -1 Patients undergo allogeneic or syngeneic bone marrow or peripheral blood stem cell transplantation on day 0 Patients receive graft-vs-host disease prophylaxis comprising mycophenolate mofetil twice daily beginning on day -3 methylprednisolone beginning on day 5 and continuing over 8 weeks and cyclosporine IV or orally beginning on day -3 and continuing until at least 6 months post-transplantation
Patients are followed at 1 3 and 6 months and then at 1 year post-transplantation
PROJECTED ACCRUAL A total of 52 patients will be accrued for this study within 5-6 years
Determine the hematopoietic recovery in patients with hematologic malignancies or genetic disorders treated with fludarabine and melphalan followed by allogeneic or syngeneic bone marrow or peripheral blood stem cell transplantation
Determine the chemotherapeutic toxicity of this regimen in these patients
Determine the relapse and survival of patients treated with this regimen
Determine the incidence of graft-versus-host disease in patients treated with this regimen
OUTLINE Patients receive fludarabine IV on days -6 to -2 and melphalan IV on days -3 and -2 Patients with a non-HLA-identical family member may also receive anti-thymocyte globulin on days -4 to -1 Patients undergo allogeneic or syngeneic bone marrow or peripheral blood stem cell transplantation on day 0 Patients receive graft-vs-host disease prophylaxis comprising mycophenolate mofetil twice daily beginning on day -3 methylprednisolone beginning on day 5 and continuing over 8 weeks and cyclosporine IV or orally beginning on day -3 and continuing until at least 6 months post-transplantation
Patients are followed at 1 3 and 6 months and then at 1 year post-transplantation
PROJECTED ACCRUAL A total of 52 patients will be accrued for this study within 5-6 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CPMC-IRB-8462 | None | None | None |
| CPMC-IRB-CAMP-25 | None | None | None |
| NCI-G00-1897 | None | None | None |