Cirmtuzumab Consolidation for Chronic Lymphocytic Leukemia
(Venetoclax Trial)

Recruiting in Palo Alto (17 mi)

Overseen byBenjamin M Heyman, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of California, San Diego

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

Single center, open-label, phase 2 study to determine the efficacy of cirmtuzumab consolidation in patients with measurable disease on venetoclax.

Eligibility Criteria

This trial is for patients with chronic lymphocytic leukemia (CLL) who still have detectable disease after at least 12 months on venetoclax. They must not have significant uncontrolled conditions or infections, and women cannot be pregnant or breastfeeding. Those recently treated with certain therapies or having another malignancy may be excluded.

Inclusion Criteria

I stopped taking venetoclax over 6 months ago and my cancer is considered low risk.

My blood test shows more than 0.01% leukemia cells.

I am currently taking venetoclax.

See 2 more

Exclusion Criteria

Evidence of other clinically significant uncontrolled condition(s) including, but not limited to: uncontrolled and/or active systemic infection (viral, bacterial or fungal), chronic hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment. Note: subjects with serologic evidence of prior vaccination to HBV (i.e. hepatitis B surface (HBs) antigen negative, anti-HBs antibody positive and anti-hepatitis B core (HBc) antibody negative) or positive anti-HBc antibody from intravenous immunoglobulins (IVIG) may participate, Child class B or C cirrhosis, treatment with any of the following within 7 days prior to the first dose of cirmtuzumab: steroid therapy for anti-neoplastic intent, biologic agent (monoclonal antibody) within 30 days for anti-neoplastic intent, chemotherapy (purine analog or alkylating agent) or target small molecule agent within 14 days or 5 half-lives (whichever is shorter), or has not recovered to less than CTCAE grade 2 clinically significant adverse effect(s)/toxicity(s) of previous therapy, CLL therapy, aside from venetoclax, history of other malignancy that could affect compliance with the protocol or interpretation of results (example: patients with a history of curatively treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix are generally eligible), women who are pregnant or lactating

Treatment Details

Interventions

Cirmtuzumab (Monoclonal Antibodies)
Venetoclax (Anti-tumor antibiotic)

Trial OverviewThe study is testing the effectiveness of cirmtuzumab given to patients who are already taking venetoclax but still show signs of CLL. It's a phase 2 trial where all participants will receive cirmtuzumab to see if it can further reduce leukemia cells.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Cirmtuzumab + VenetoclaxExperimental Treatment2 Interventions

All patients will receive a minimum of 6 cycles (cycle = 28 days) of therapy with venetoclax and cirmtuzumab during the treatment period. For patients who achieve undetectable minimal residual disease (uMRD) positive after cycle 6, an additional 6 cycles of venetoclax and cirmtuzumab may be administered.

Venetoclax is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Venclexta for: