Clinical Trials /

Cirmtuzumab Consolidation for Treatment of Patients With Detectable CLL on Venetoclax

NCT04501939

Description:

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

Related Conditions:
  • Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Cirmtuzumab Consolidation for Treatment of Patients With Detectable CLL on Venetoclax
  • Official Title: Cirmtuzumab Consolidation for Treatment of Patients With Detectable CLL on Venetoclax

Clinical Trial IDs

  • ORG STUDY ID: 191407
  • NCT ID: NCT04501939

Conditions

  • Chronic Lymphocytic Leukemia

Interventions

DrugSynonymsArms
CirmtuzumabCirmtuzumab + Venetoclax
VenetoclaxCirmtuzumab + Venetoclax

Purpose

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 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.
    

Trial Arms

NameTypeDescriptionInterventions
Cirmtuzumab + VenetoclaxExperimentalAll 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.
  • Cirmtuzumab
  • Venetoclax

Eligibility Criteria

        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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Percentage of subjects with undetectable measurable residual disease after 6 months of cirmtuzumab + venetoclax treatment.
Time Frame:6-24 months
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Number of subjects with treatment-related adverse events as assessed by CTCAE v5.0.
Time Frame:9-15 months
Safety Issue:
Description:
Measure:Time to next CLL treatment.
Time Frame:9-24 months
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:University of California, San Diego

Trial Keywords

  • chronic lymphocytic leukemia
  • CLL
  • cirmtuzumab
  • venetoclax

Last Updated

October 19, 2020