A Study to Evaluate VIP152 in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia or Richter Syndrome
NCT ID: NCT04978779
Last Updated: 2023-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
6 participants
INTERVENTIONAL
2021-12-16
2023-05-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Monotherapy of VIP152
Investigating VIP152 in a monotherapy cohort in patients with high-risk CLL and Richter Syndrome
VIP152
Weekly IV infusion for 28 day cycles.
VIP152 in combination with BTKi
Investigating VIP152 in combination with a BTKi in patients with CLL
VIP152
Weekly IV infusion for 28 day cycles.
BTKi
Taken per local prescribing information
Interventions
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VIP152
Weekly IV infusion for 28 day cycles.
BTKi
Taken per local prescribing information
Eligibility Criteria
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Inclusion Criteria
* Adequate bone marrow, liver, and renal functions
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
* Diseases as defined below:
PART1
* Subjects with CLL with either del(17p) by FISH or TP53 mutation who have received ≥1 prior therap(ies) and the last prior regimen must have included venetoclax plus an anti-CD20 antibody and/or a BTKi and did not produce complete remission. Subjects with CLL with either del(17p) by FISH or TP53 mutation who have received ≥2 prior regimens and are intolerant to BTKi and/or venetoclax are also eligible.
or
* Subjects with CLL transformed to DLBCL who have relapsed after, or been refractory, to at least 1 prior line of therapy for DLBCL
PART2
* Subjects with CLL who are currently on an approved BTKi (monotherapy only) at the dose and schedule per the local label for ≥ 12 months who have only achieved SD, PR or PRL
Exclusion Criteria
* Subjects who have new or progressive brain or meningeal or spinal metastases.
* Anticancer chemotherapy or immunotherapy during the study or within one week prior to the first dose of study drug
* Major surgery or significant trauma within 4 weeks before the first dose of study drug
* Allogeneic bone marrow transplant or stem cell rescue within 4 months before first dose of study drug; patients must have completed immunosuppressive therapy before enrollment
18 Years
ALL
No
Sponsors
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Vincerx Pharma, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Vincerx Study Director
Role: STUDY_DIRECTOR
Vincerx Pharma, Inc.
Locations
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University of Cincinnati Medical Center
Cincinnati, Ohio, United States
The Ohio State University
Columbus, Ohio, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Pratia MCM Krakow
Krakow, , Poland
Countries
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References
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Frigault MM, Mithal A, Wong H, Stelte-Ludwig B, Mandava V, Huang X, Birkett J, Johnson AJ, Izumi R, Hamdy A. Enitociclib, a Selective CDK9 Inhibitor, Induces Complete Regression of MYC+ Lymphoma by Downregulation of RNA Polymerase II Mediated Transcription. Cancer Res Commun. 2023 Nov 9;3(11):2268-2279. doi: 10.1158/2767-9764.CRC-23-0219.
Other Identifiers
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VNC-152-102
Identifier Type: -
Identifier Source: org_study_id
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