NCT04473911CompletedPhase 1
Haplo Peripheral Blood Sct In GVHD Prevention
Reduced Intensity Haploidentical Peripheral Blood Stem Cell Transplantation With Post-transplant Cyclophosphamide and Sirolimus/Mycophenolate Mofetil/RGI-2001 Based GVHD Prevention: a Pilot Study
Source: ClinicalTrials.gov · Last updated 20 Jul 2025
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 25 (actual)
- First submitted
- 13 Jul 2020
- Start date
- 14 Aug 2020
- Primary completion date
- 22 Oct 2023
- Lead sponsor
- Zachariah Michael DeFilipp
- Diseases
- Acute lymphoblastic leukaemia, Myeloproliferative neoplasms, Hodgkin lymphoma, Chronic myeloid leukaemia, Myelodysplastic syndromes, Chronic lymphocytic leukaemia, Acute myeloid leukemia
- NCT number
- NCT04473911
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 25
- From 14 Aug 2020 to the primary completion date, 22 Oct 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Pregnant and breast-feeding women are ineligible because they are not eligible for hematopoietic stem cell transplantation.
Other illness
- 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.
- HIV-positive participants and patients with active Hepatitis B or C are ineligible
Lab values
- Planned use of prophylactic donor lymphocyte infusion (DLI) therapy.
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.