- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04501939
Cirmtuzumab Consolidation for Treatment of Patients With Detectable CLL on Venetoclax (Venetoclax)
November 27, 2023 updated by: Benjamin Heyman, University of California, San Diego
Single center, open-label, phase 2 study to determine the efficacy of cirmtuzumab consolidation in patients with measurable disease on venetoclax.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
5
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Benjamin Heyman, MD
- Phone Number: (858) 246-3038
- Email: bheyman@health.ucsd.edu
Study Contact Backup
- Name: Betty Cabrera, MPH
- Phone Number: 858-534-5932
- Email: blcabrera@health.ucsd.edu
Study Locations
-
-
California
-
San Diego, California, United States, 92037
- UCSD Koman Family Outpatient Pavilion
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cirmtuzumab + Venetoclax
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.
|
Cycle 1, Day 1 & 15 - 600mg Cycle 2, Day 1 to Cycle 6, Day 1 - 600mg
Other Names:
Venetoclax 400mg PO daily from cycle 1 day 1 for 6 cycles of 28 days.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cancer response to treatment
Time Frame: 6-24 months
|
Percentage of subjects with undetectable measurable residual disease after 6 months of cirmtuzumab + venetoclax treatment.
|
6-24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Frequency of adverse events
Time Frame: 9-15 months
|
Number of subjects with treatment-related adverse events as assessed by CTCAE v5.0.
|
9-15 months
|
Time to next CLL treatment.
Time Frame: 9-24 months
|
Measurement of time of anti-cancer activity
|
9-24 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in gene expression in leukemic cells
Time Frame: 9-15 months
|
The change in gene expression of leukemia cells by single cell PCR or RNA after treatment with cirmtuzumab, including analysis of archival pre-venetoclax sample, when available.
|
9-15 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Benjamin M Heyman, MD, University of California, San Diego
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 6, 2020
Primary Completion (Estimated)
July 22, 2025
Study Completion (Estimated)
July 22, 2025
Study Registration Dates
First Submitted
July 22, 2020
First Submitted That Met QC Criteria
August 3, 2020
First Posted (Actual)
August 6, 2020
Study Record Updates
Last Update Posted (Actual)
November 28, 2023
Last Update Submitted That Met QC Criteria
November 27, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Disease Attributes
- Leukemia
- Leukemia, B-Cell
- Chronic Disease
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Lymphoid
- Antineoplastic Agents
- Venetoclax
Other Study ID Numbers
- 191407 (IRAS project ID)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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