Active — Not RecruitingPhase 1/2

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

United States72 participantsStarted 2021-04-16

Plain-language summary

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

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✕. Patients who have received investigational therapy, radiotherapy, immunotherapy, monoclonal antibodies, or chemotherapy within 14 days or 5 half-lives (whichever is shorter)
✕. 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.
✕. Any Grade ≥ 2 persistent non-hematological toxicity related to allogeneic transplant, such as those requiring systemic immunosuppressive therapy.

Incidence of treatment emergent AEs

Timeframe: 36 months

Treatment emergent changes in vital signs

Timeframe: 36 months

Treatment emergent changes in clinical laboratory tests

Timeframe: 36 months

Treatment emergent changes in physical examinations, ECOG performance status, electrocardiograms (ECGs), echocardiograms and cardiac troponins

Timeframe: 36 months

NCT IDNCT04730258

SponsorTreadwell Therapeutics, Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-01

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✕. Patients who have received investigational therapy, radiotherapy, immunotherapy, monoclonal antibodies, or chemotherapy within 14 days or 5 half-lives (whichever is shorter)
✕. 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.
✕. Any Grade ≥ 2 persistent non-hematological toxicity related to allogeneic transplant, such as those requiring systemic immunosuppressive therapy.

What they're measuring

Incidence of treatment emergent AEs

Timeframe: 36 months

Treatment emergent changes in vital signs

Timeframe: 36 months

Treatment emergent changes in clinical laboratory tests

Timeframe: 36 months

Treatment emergent changes in physical examinations, ECOG performance status, electrocardiograms (ECGs), echocardiograms and cardiac troponins

Timeframe: 36 months