Cirmtuzumab Consolidation for Treatment of Patients With Detectable CLL on Venetoclax (Venetoclax)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04501939|
Recruitment Status : Recruiting
First Posted : August 6, 2020
Last Update Posted : November 29, 2021
|Condition or disease||Intervention/treatment||Phase|
|Chronic Lymphocytic Leukemia||Drug: Cirmtuzumab Drug: Venetoclax||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Cirmtuzumab Consolidation for Treatment of Patients With Detectable CLL on Venetoclax|
|Actual Study Start Date :||August 6, 2020|
|Estimated Primary Completion Date :||July 22, 2025|
|Estimated Study Completion Date :||July 22, 2025|
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
Venetoclax 400mg PO daily from cycle 1 day 1 for 6 cycles of 28 days.
- Percentage of subjects with undetectable measurable residual disease after 6 months of cirmtuzumab + venetoclax treatment. [ Time Frame: 6-24 months ]
- Number of subjects with treatment-related adverse events as assessed by CTCAE v5.0. [ Time Frame: 9-15 months ]
- Time to next CLL treatment. [ Time Frame: 9-24 months ]
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04501939
|Contact: Thuy Phamfirstname.lastname@example.org|
|United States, California|
|UCSD Koman Family Outpatient Pavilion||Recruiting|
|San Diego, California, United States, 92037|
|Contact: Elizabeth Miller 858-249-3000 email@example.com|
|Principal Investigator:||Benjamin M Heyman, MD||University of California, San Diego|