Clinical trial · Interventional
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
NCT04473911CI-TRIAL-00092403completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (16)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| ALL | Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| AML | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Blood Stem Cell Transplant Failure | — | UNRESOLVED | — |
| Chemosensitive Hodgkin Lymphoma | — | UNRESOLVED | — |
| Chronic Myelomonocytic Leukemia | Chronic Myelomonocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
| CMML | Chronic Myelomonocytic Leukemia |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CYCLOPHOSPHAMIDE | Drug | Cyclophosphamide | ALIAS |
| FLUDARABINE | Drug | Fludarabine | ALIAS |
| Melphalan | Drug | Melphalan | ALIAS |
| Mycophenolate mofetil | Drug | — | UNRESOLVED |
| RGI-2001 | Drug | — | UNRESOLVED |
| Sirolimus | Drug | Sirolimus | ALIAS |
| TBI | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Regimen 1: Fludarabine, Cyclophosphamide, and TBI
- description
- -. Patients who meet eligibility criteria for the study will subsequently be enrolled for treatment. Two reduced intensity regimens will be allowed, according to the choice of the treating physician * Pre- stem cell transplant: * Fludarabine predetermined dose, intravenously, 4 times per cycle * Cyclophosphamide predetermined dose, predetermined number of times in cycle, intravenous infusion * Total body irradiation (TBI) once during treatment cycle * Post stem cell transplant: * Cyclophosphamide predetermined dose, predetermined number of times in cycle, intravenous infusion * Sirolimus: Predetermined dosage, predetermined number of time in cycle, oral. * Mycophenolate mofetil, oral or iv(predetermined dose or IV TID (based upon actual body weight), at predetermined times per cycle * RGI-2001: IV, predetermined dose, weekly to 6 total doses
- interventionNames
- Drug: FLUDARABINE
- Drug: CYCLOPHOSPHAMIDE
- Radiation: TBI
- Drug: Sirolimus
- Drug: Mycophenolate mofetil
- Drug: RGI-2001
- type
- EXPERIMENTAL
- label
- Regimen 2: Fludarabine, Melphalan, and TBI
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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 ineligibleReferences
Publications (0)
Data not yet available
No reference posted for this study.