Description:
Single center, open-label, phase 2 study to determine the efficacy of cirmtuzumab
consolidation in patients with measurable disease on venetoclax.
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
Drug | Synonyms | Arms |
---|
Cirmtuzumab | | Cirmtuzumab + Venetoclax |
Venetoclax | | Cirmtuzumab + 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
Name | Type | Description | Interventions |
---|
Cirmtuzumab + Venetoclax | Experimental | 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. | |
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