Haploidentical Stem Cell Transplantation Using Post-Transplant Cyclophosphamide
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Acute Lymphocytic Leukemia
- Acute Myeloid Leukemia
- Chronic Lymphocytic Leukemia
- Myelodysplastic Syndrome
- Non Hodgkin Lymphoma
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Prevention
Participation Requirements
- Age
- Between 16 years and 90 years
- Gender
- Both males and females
Description
An open label, single-arm, single-center study to evaluate the safety, efficacy and feasibility of haplo-SCT as an alternative donor source for patients who lack a matched sibling/unrelated donor options. The choice of the chemotherapy treatment for transplantation will be up to the investigator. Po...
An open label, single-arm, single-center study to evaluate the safety, efficacy and feasibility of haplo-SCT as an alternative donor source for patients who lack a matched sibling/unrelated donor options. The choice of the chemotherapy treatment for transplantation will be up to the investigator. Post-transplant cyclophosphamide will serve as the backbone of the immunosuppression treatment to prevent GVHD. GVHD Prevention Treatment: Cyclophosphamide will be administered IV on Day 3 and Day 5 post transplant. Tacrolimus will be administered IV until patient can take it by mouth starting on day of transplant and continue approximately 100 days post-transplant. Mycophenolate mofetil will be administered IV until patient can take it by mouth starting on Day 1 post transplant until 28 days.
Tracking Information
- NCT #
- NCT03088709
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Zeina Al-Mansour, MD Cardinal Bernardin Cancer Center, Loyola University