Cirmtuzumab Consolidation for Treatment of Patients With Detectable CLL on Venetoclax

  • STATUS
    Recruiting
  • End date
    Jul 22, 2025
  • participants needed
    16
  • sponsor
    University of California, San Diego
Updated on 8 December 2021
chronic lymphocytic leukemia
measurable disease
venetoclax

Summary

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

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 blood in patients who have been treated with venetoclax for at least one year. Consolidation therapy is given after initial cancer treatment to further reduce the number of cancer cells that may be left in the body. Cirmtuzumab, a monoclonal antibody that inhibits receptor tyrosine kinase like orphan receptor (ROR1) signaling and stemness, may be effective in reducing the risk of disease progression in patients with detectable minimal residual disease (MRD) after treatment with venetoclax.

Details
Condition Lymphocytic Leukemia, Chronic, small lymphocytic lymphoma, Chronic Lymphocytic Leukemia, leukemia chronic lymphocytic, chronic lymphocytic leukemia (cll)
Treatment venetoclax, cirmtuzumab
Clinical Study IdentifierNCT04501939
SponsorUniversity of California, San Diego
Last Modified on8 December 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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 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
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