Haplo Peripheral Blood Sct In GVHD Prevention
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Acute Myeloid Leukemia
- Acute Lymphoblastic Leukemia
- Myeloproliferative Disorder
- Myelodysplastic Syndromes
- ALL
- AML
- Blood Stem Cell Transplant Failure
- Chemosensitive Hodgkin Lymphoma
- Chronic Myelomonocytic Leukemia
- CMML
- Non Hodgkin Lymphoma
- Graft Vs Host Disease
- MPN
- GVHD
- Hodgkin Lymphoma
- MDS
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 80 years
- Gender
- Both males and females
Description
This is a pilot study in subjects undergoing reduced-intensity haploidentical peripheral blood stem cell transplantation who will receive graft-versus-host disease prevention with post-transplant cyclophosphamide, followed by sirolimus, mycophenolate mofetil, and RGI-2001. The research study procedu...
This is a pilot study in subjects undergoing reduced-intensity haploidentical peripheral blood stem cell transplantation who will receive graft-versus-host disease prevention with post-transplant cyclophosphamide, followed by sirolimus, mycophenolate mofetil, and RGI-2001. The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. The standard of care drugs of fludarabine, cyclophosphamide, melphalan, radiation, sirolimus, and mycophenolate mofetil are all FDA approved. Eligible Participants will be placed in 1 of 2 groups, per physicians discretion: Regimen #1 : Before stem cell transplant:Fludarabine + Cyclophosphamide + Radiation After stem cell transplant: Cyclophosphamide + Sirolimus +Mycophenolate mofetil + RGI-2001 Regimen #2 Before stem cell transplant: fludarabine + melphalan + radiation After stem cell transplant: cyclophosphamide + sirolimus +Mycophenolate mofetil + RGI-2001 A total of 20 participants will be enrolled to this trial The U.S. Food and Drug Administration (FDA) has not approved RGI-2001 as a treatment for any disease.
Tracking Information
- NCT #
- NCT04473911
- Collaborators
- Regimmune Corporation
- Investigators
- Principal Investigator: Zachariah DeFilipp, MD Massachusetts General Hospital
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