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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. Identifier: NCT04501939
Recruitment Status : Recruiting
First Posted : August 6, 2020
Last Update Posted : March 3, 2023
Oncternal Therapeutics, Inc
Information provided by (Responsible Party):
Benjamin Heyman, University of California, San Diego

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

Condition or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia Drug: Cirmtuzumab Drug: Venetoclax Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

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.
Drug: Cirmtuzumab
Cycle 1, Day 1 & 15 - 600mg Cycle 2, Day 1 to Cycle 6, Day 1 - 600mg
Other Name: Zilovertamab

Drug: Venetoclax
Venetoclax 400mg PO daily from cycle 1 day 1 for 6 cycles of 28 days.

Primary Outcome Measures :
  1. Cancer response to treatment [ Time Frame: 6-24 months ]
    Percentage of subjects with undetectable measurable residual disease after 6 months of cirmtuzumab + venetoclax treatment.

Secondary Outcome Measures :
  1. Frequency of adverse events [ Time Frame: 9-15 months ]
    Number of subjects with treatment-related adverse events as assessed by CTCAE v5.0.

  2. Time to next CLL treatment. [ Time Frame: 9-24 months ]
    Measurement of time of anti-cancer activity

Other Outcome Measures:
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT04501939

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Contact: Benjamin Heyman, MD (858) 246-3038
Contact: Betty Cabrera, MPH 858-534-5932

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United States, California
UCSD Koman Family Outpatient Pavilion Recruiting
San Diego, California, United States, 92037
Contact: Elizabeth Miller    858-249-3000   
Sponsors and Collaborators
University of California, San Diego
Oncternal Therapeutics, Inc
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Principal Investigator: Benjamin M Heyman, MD University of California, San Diego
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Benjamin Heyman, Assistant Clinical Professor, University of California, San Diego Identifier: NCT04501939    
Other Study ID Numbers: 191407
First Posted: August 6, 2020    Key Record Dates
Last Update Posted: March 3, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Benjamin Heyman, University of California, San Diego:
chronic lymphocytic leukemia
Additional relevant MeSH terms:
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Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Chronic Disease
Disease Attributes
Pathologic Processes
Antineoplastic Agents