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
Who can participate
Age range18 Years – 80 Years
SexALL
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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 …
What they're measuring
1
Number of patients achieving successful donor engraftment