Haplo Peripheral Blood Sct In GVHD Prevention

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

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), myeloproliferative disorders (MPN), chronic myelomonocytic leukemic (CMML), chemosensitive hodgkin lymphoma (HL), or Non-Hodgkin lymphoma (NHL).who will have a blood stem cell transplantation.

• GVHD is a condition in which cells from the donor's tissue attack the organs.

• RGI-2001 is an investigational treatment

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zachariah Michael DeFilipp
• Collaborator: Regimmune Corporation
• Treatments: Cyclophosphamide; Fludarabine; Melphalan; Mycophenolic Acid; Sirolimus

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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