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A Study of CFI-400945 With or Without Azacitidine in Patients With AML, MDS or CMML | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE1/PHASE2

A Study of CFI-400945 With or Without Azacitidine in Patients With AML, MDS or CMML

Phase 1b/2 Clinical Study of the Safety, Tolerability, and Pharmacokinetic and Pharmacodynamic Profiles of CFI-400945 as a Single Agent or in Combination With Azacitidine in Patients With AML, MDS or CMML

NCT04730258•Treadwell Therapeutics, Inc

View on ClinicalTrials.gov

Summary

The purpose of this study is to test the safety of an investigational drug called CFI-400945 alone and in combination with azacitidine.

Detailed Description

This study will be evaluating the safety and tolerability of CFI-400945 in subjects with Acute Myeloid Leukemia, Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia. The study is designed to build on encouraging data from another study and to obtain further safety, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) data of CFI-400945.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patients must be \>18 years of age
•2. For Parts 1A and 1B, the following malignancy types will be included:
•1. Relapsed or refractory AML.
•2. MDS, after prior hypomethylating agents.
•3. CMML, with progressive disease/lack of response after hypomethylating agents
•For Parts 1A and 1B, Patients may have relapsed or refractory disease.
•3. For Parts 2A and 2B, the following malignancy types will be included:
•1. Relapsed or Refractory AML.
•2. MDS patients should be limited to high risk disease
•3. MDS or CMML should be previously untreated and patients with AML may have relapsed or refractory disease;
+2 more criteria

Exclusion Criteria

•1. Patients who have received investigational therapy, radiotherapy, immunotherapy, monoclonal antibodies, or chemotherapy within 14 days or 5 half-lives (whichever is shorter)
•2. Allogeneic or autologous transplant for AML with infusion of stem cells within 90 days before Cycle 1 Day 1, or on active immunosuppressive therapy for graft-versus-host disease (GVHD) or GVHD prophylaxis within 2 weeks of Cycle 1 Day 1.
•3. Any Grade ≥ 2 persistent non-hematological toxicity related to allogeneic transplant, such as those requiring systemic immunosuppressive therapy.

Locations (9)

City of Hope

Duarte, California, United States

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

Norton Cancer Institute - Saint Matthews

Louisville, Kentucky, United States

New York Presbyterian Weill Cornell Medical Center

New York, New York, United States

The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

The University of Texas MD Anderson Cancer Centre

Houston, Texas, United States

University of Alberta

Edmonton, Alberta, Canada

Princess Margaret Cancer Center

Toronto, Ontario, Canada

Queen Mary Hospital

Hong Kong, Hong Kong

Key Dates

Start Date

April 16, 2021

Primary Completion Date

January 1, 2026

Completion Date

January 1, 2026

Last Updated

May 18, 2025

Enrollment

ESTIMATED participants

Conditions

Acute Myeloid LeukemiaMyelodysplastic SyndromesChronic Myelomonocytic LeukemiaAMLMDSCMML

Interventions

CFI-400945

DRUG

Azacitidine

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 18, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Study of CFI-400945 With or Without Azacitidine in Patients With AML, MDS or CMML

Inclusion Criteria

Exclusion Criteria

Phase I Study of HC-7366 for Acute Myeloid Leukemia

VAC Regimen for AML Patients Who Failed to Response to VA Regimen

A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation

A Platform Protocol to Investigate Post-Transplant Cyclophosphamide-Based Graft-Versus-Host Disease Prophylaxis in Patients With Hematologic Malignancies Undergoing Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation

Testing the Anti-cancer Drug, Cirtuvivint, and Its Combination With ASTX727 to Improve Outcomes in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndromes

Phase III Study of Induction and Consolidation Chemotherapy With Venetoclax in Patients With Newly Diagnosed AML or MDS-EB-2