RPT1G for adults with relapsed or refractory acute myeloid leukemia and high-risk MDS

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1, open-label dose-finding study gives RPT1G to adults with relapsed or refractory acute myeloid leukemia (AML) or high-risk myelodysplastic syndromes (MDS) to determine safety, tolerability, and an optimal dose and schedule. Eligible participants have had appropriate prior standard therapy (or declined it) and must meet performance status (ECOG ≤2) and organ-function criteria. Patients receive RPT1G on a protocol-defined schedule with frequent clinical and laboratory monitoring for adverse events and early signs of anti-leukemia activity. Dose-escalation and safety review procedures guide dose and schedule decisions at participating cancer centers.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance status ≤2
* Histological confirmation of AML (ELN 2022 criteria) that relapsed and/or refractory AML or high-risk MDS as defined by International Consortium for MDS (icMDS) 2023 criteria that have received appropriate standard of care therapy, in the opinion of the investigator or declined receipt of these
* Organ function/reserve as per the following laboratory criteria:
* Hepatic: Aspartate aminotransferase (AST) ≤2.5 x upper limit of normal (ULN), alanine aminotransferase (ALT) ≤2.5 x ULN, and total bilirubin \<2 x ULN (except for study patients with known Gilbert's where 1.5 x UL of the subject's baseline or in the case of suspected Gilbert's syndrome where a maximum total bilirubin level of 4.0 mg/dL is acceptable) for the local laboratory. If due to disease, higher values may be approved after discussion with medical monitor.
* Renal: Adequate renal function as defined by calculated creatinine clearance \>50 mL/min for the CLIA certified local laboratory. Creatinine clearance must be calculated by Cockcroft-Gault equation.

Key Exclusion Criteria:

* Patients without evidence of blood or marrow involvement
* Acute promyelocytic leukemia
* Symptomatic central nervous system involvement by AML
* Clinical signs/symptoms of leukostasis requiring urgent therapy
* Active infections
* Radiotherapy \<14 days prior to the first day of RPT1G administration
* Ongoing complications from prior therapy
* Prior or concurrent malignancy
* Any other condition, therapy, treatment, or comorbidity that leads the investigator to determine that the study is not in the best interest of the patient

Where it's running

• Memorial Sloan Kettering Cancer Center
  New York, New York, United States Recruiting
• MD Anderson Cancer Center
  Houston, Texas, United States Recruiting

Study contacts

• Study coordinator: Eunice Vukosavljevic, CP, Director of Clinical Operations
• Email: clinical@remedyplan.com
• Phone: 240-408-4854

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Low-dose Liposomal Amphotericin B for preventing fungal infections in adults with blood cancers and prolonged neutropenia

  This study tests whether giving a daily 50 mg dose of liposomal amphotericin B can help prevent invasive fungal infections in adults with blood cancers who have prolonged low white blood cell counts.

  Recruiting Haikou Affiliated Hospital of Central South University Xiangya School of Medicine · Hainan, Hainan · NCT07763054

• Adding FHD-286 to low‑dose decitabine and venetoclax for adverse‑risk AML

  This trial tests whether adding FHD-286 to a low‑dose decitabine plus venetoclax regimen helps people with newly diagnosed adverse‑risk acute myeloid leukemia or AML that progressed after one prior therapy.

  Recruiting Phase 1 Montefiore Medical Center · The Bronx, New York · NCT07283094

• Prophylactic DLI-X to Prevent Leukemia Relapse After Transplant

  This first-in-human trial tests a prophylactic DLI-X approach to see if it can prevent relapse after matched sibling or haploidentical stem cell transplant in patients with acute leukemias and related blood disorders.

  Recruiting Phase 1 University of Arizona · Tucson, Arizona · NCT07254793

• Induction and consolidation using fludarabine, cytarabine, idarubicin, and venetoclax for acute myeloid leukemia

  This trial tests whether adding venetoclax to induction and consolidation chemotherapy (fludarabine, cytarabine, and idarubicin) helps adults 18–65 with newly diagnosed acute myeloid leukemia or high-blast myelodysplastic syndrome achieve deeper remissions than standard cytarabine/daunorubicin therapy.

  Recruiting Phase 2 OHSU Knight Cancer Institute · Portland, Oregon · NCT07228273

• FLAG‑Ida chemotherapy followed by reduced‑intensity total‑body irradiation and donor stem cell transplant for adults 60+ with adverse‑risk AML or other high‑grade myeloid cancers

  This trial tests whether FLAG‑Ida chemotherapy given immediately before lower‑intensity total‑body radiation and a donor stem cell transplant can improve outcomes for adults 60 and older with newly diagnosed adverse‑risk acute myeloid leukemia or similar high‑grade myeloid cancers.

  Recruiting Phase 2 Fred Hutchinson Cancer Center · Seattle, Washington · NCT07046078

• CMV Triplex vaccine to boost immunity and prevent CMV after haploidentical stem cell transplant

  This trial tests whether giving a CMV-MVA Triplex vaccine to donors and/or recipients, with or without the antiviral letermovir, can boost CMV immunity and prevent CMV viremia in people having haploidentical stem cell transplants.

  Recruiting at 3 sites Phase 1 City of Hope Medical Center · Duarte, California and 2 other locations · NCT07020533

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.