Status:
COMPLETED
Haplo Peripheral Blood Sct In GVHD Prevention
Lead Sponsor:
Zachariah Michael DeFilipp
Collaborating Sponsors:
Regimmune Corporation
Conditions:
GVHD
AML
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief Summary
This research study is studying the RGI-2001 for preventing Graft-vs-Host Disease (GVHD) in people with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), myelodysplastic syndrome (MDS)...
Detailed 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 cy...
Eligibility Criteria
Inclusion
- Men or women ≥ 18 and ≤ 80 years old
- Diagnosis of hematological malignancy:
- Acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) in morphologic complete remission
- Myelodysplastic syndrome (MDS), myeloproliferative disorders (MPN), or chronic myelomonocytic leukemic (CMML) with \< 5% blasts in blood or bone marrow
- Chemosensitive Hodgkin lymphoma (HL) or Non-Hodgkin lymphoma (NHL)
- Patients must be undergoing haploidentical allogeneic hematopoietic cell transplantation, defined as 1st or 2nd degree relative with at least 5/10 matching at HLA-A, -B, -C, DR, and DQ.
- ECOG performance status ≤2
- Patients with adequate physical function as measured by:
- Cardiac: Left ventricular ejection fraction at rest must be ≥ 40%, or shortening fraction \>25%
- Hepatic:
- Bilirubin ≤ 2.5 mg/dL, except for patients with Gilbert's syndrome or hemolysis
- ALT, AST, and Alkaline Phosphatase \< 5 x ULN
- Renal: Serum creatinine within normal range, or if serum creatinine is outside normal range, then renal function (measured or estimated creatinine clearance or GFR) ≥ 40mL/min/1.73m2
- Pulmonary: DLCO (corrected for hemoglobin), FEV1 and FVC ≥ 50% predicted
- Ability to understand and the willingness to sign a written informed consent document
Exclusion
- Prior allogeneic hematopoietic stem cell transplantation. (Patients may have received a prior autologous hematopoietic stem cell transplant.)
- Participants who are receiving any other investigational agents within 14 days prior to RGI-2001 dosing. Thus, participants must stop investigational agents by Day -9 prior to transplant.
- Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, recent myocardial infarction or stroke, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Patients with active or uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
- Planned use of prophylactic donor lymphocyte infusion (DLI) therapy.
- Pregnant and breast-feeding women are ineligible because they are not eligible for hematopoietic stem cell transplantation.
- HIV-positive participants and patients with active Hepatitis B or C are ineligible
Key Trial Info
Start Date :
August 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 19 2024
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04473911
Start Date
August 14 2020
End Date
August 19 2024
Last Update
July 20 2025
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115