Nonmyeloablative Allogeneic Stem Cell Transplant for the Treatment of Hematologic Disorders
Overview
- Phase
- Phase 2
- Intervention
- Cyclophosphamide
- Conditions
- AML
- Sponsor
- Beth Israel Deaconess Medical Center
- Enrollment
- 25
- Primary Endpoint
- durable engraftment
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
The purpose of this study is to provide allogeneic stem cell transplantation to patients who have not traditionally undergone this procedure because of it high incidence of treatment related side effects. We hope to decrease these side effects by decreasing the chemotherapy dose prior to transplant (non-myeloablative, smaller dose of chemotherapy given so bone marrow is not completely eliminated) and by using donated stem cells to treat cancer of the blood.
Investigators
David McDermott
Associate Professor of Medicine
Beth Israel Deaconess Medical Center
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
1
Study treatment arm with G-CSF
Intervention: Cyclophosphamide
1
Study treatment arm with G-CSF
Intervention: fludarabine
1
Study treatment arm with G-CSF
Intervention: cyclosporine
1
Study treatment arm with G-CSF
Intervention: methotrexate
1
Study treatment arm with G-CSF
Intervention: G-CSF
Outcomes
Primary Outcomes
durable engraftment
Time Frame: 100 days
hematopoeitic reconstitution
Time Frame: 3 years
evaluate the patterns of post-transplant chimerism among lymphoid and antigen presenting cells
Time Frame: 3 years
Secondary Outcomes
- disease free survival and overall survival(3 years)
- incidence of treatment related toxicity and acute and chronic graft versus host disease(100 days)