Haplo Peripheral Blood Sct In GVHD Prevention

• 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.

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