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Anti-tumor antibiotic

Cirmtuzumab Consolidation for Chronic Lymphocytic Leukemia (Venetoclax Trial)

Phase 2

Waitlist Available

Led By Benjamin M Heyman, MD

Research Sponsored by University of California, San Diego

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must have detectable CLL/SLL (> 0.01% leukemia cells present)

Must have received at least 12 months of venetoclax

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 9-24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether a drug called cirmtuzumab can help people with cancer who have responded to treatment with venetoclax.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Potential side effects include reactions related to the immune system, such as infusion reactions from cirmtuzumab, and those associated with venetoclax like low blood cell counts, fatigue, nausea, and risk of infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My blood test shows more than 0.01% leukemia cells.

Select...

I have been on venetoclax for at least 12 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 9-24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~9-24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 9-24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Cancer response to treatment

Secondary study objectives

Frequency of adverse events

Time to next CLL treatment.

Other study objectives

Change in gene expression in leukemic cells

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Venetoclax

2019

Completed Phase 3

~2200

0 / 2Eligibility criteria met