Status:
ACTIVE_NOT_RECRUITING
Cirmtuzumab Consolidation for Treatment of Patients With Detectable CLL on Venetoclax
Lead Sponsor:
University of California, San Diego
Collaborating Sponsors:
Oncternal Therapeutics, Inc
Conditions:
Chronic Lymphocytic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Single center, open-label, phase 2 study to determine the efficacy of cirmtuzumab consolidation in patients with measurable disease on venetoclax.
Detailed Description
This is a phase 2 study to test whether cirmtuzumab in combination with venetoclax given as consolidation therapy can decrease the number of cancer cells that may be left in the bone marrow or in the ...
Eligibility Criteria
Inclusion
- Must have detectable CLL/SLL (\> 0.01% leukemia cells present)
- Must have received at least 12 months of venetoclax.
- Patients may be receiving venetoclax at the time of screening and study entry.
- Patients who have discontinued venetoclax more than 6 months prior to study entry must still have a disease burden meeting criteria for low risk of TLS (i.e. no lymph node greater than 5 cm in diameter; absolute lymphocyte count less than 25 k/uL)
Exclusion
- 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
Key Trial Info
Start Date :
August 6 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 22 2026
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT04501939
Start Date
August 6 2020
End Date
July 22 2026
Last Update
September 2 2025
Active Locations (1)
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1
UCSD Koman Family Outpatient Pavilion
San Diego, California, United States, 92037