Active — Not RecruitingPhase 2

Cobimetinib in Newly Diagnosed or HMA-treated CMML Patients With RAS Pathway Mutations

United States14 participantsStarted 2021-01-12

Plain-language summary

This is an open-label, nonrandomized phase 2 trial to assess the efficacy of cobimetinib in RAS pathway activated CMML. All eligible patients will be treated daily with cobimetinib in 28-day cycles. Cobimetinib will be administered for three weeks followed by a one week break prior to the start of the following cycle. Patients will remain on study therapy until treatment discontinuation criteria is met.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓--Serum creatinine ≤ 2x ULN

Exclusion criteria

✕-Note: Patients on effective antiretroviral therapy with an undetectable viral load at the time of screening are eligible for this trial.
✕-Note: Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \[anti-HBc\] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.

What they're measuring

Overall Response Rate (ORR)

Timeframe: From 1st dose of study medication to decision to end treatment or up to 12 months of treatment, whichever came first

Trial details

NCT IDNCT04409639

SponsorUniversity of Utah

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-04-02

Results submitted2026-04-03

View on ClinicalTrials.gov More Chronic Myelomonocytic Leukemia (CMML) trials