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Cirmtuzumab Consolidation for Treatment of Patients With Detectable CLL on Venetoclax (Venetoclax)

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ClinicalTrials.gov Identifier: NCT04501939
Recruitment Status : Recruiting
First Posted : August 6, 2020
Last Update Posted : October 19, 2020
Sponsor:
Collaborator:
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

Resource links provided by the National Library of Medicine

Drug Information available for: Venetoclax

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

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




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

Secondary Outcome Measures :
  1. Number of subjects with treatment-related adverse events as assessed by CTCAE v5.0. [ Time Frame: 9-15 months ]
  2. Time to next CLL treatment. [ Time Frame: 9-24 months ]

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

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

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 ClinicalTrials.gov identifier (NCT number): NCT04501939


Contacts
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Contact: Benjamin M Heyman, MD 858-246-3038 bheyman@ucsd.edu

Locations
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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    eamiller@ucsd.edu   
Sponsors and Collaborators
University of California, San Diego
Oncternal Therapeutics, Inc
Investigators
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Principal Investigator: Benjamin M Heyman, MD University of California, San Diego
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Responsible Party: Benjamin Heyman, Asst Clinical Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT04501939    
Other Study ID Numbers: 191407
First Posted: August 6, 2020    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
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
CLL
cirmtuzumab
venetoclax
Additional relevant MeSH terms:
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Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Venetoclax
Antineoplastic Agents