Non Hodgkin Lymphoma Clinical Trial

A Study to Evaluate VIP152 in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia or Richter Syndrome

Summary

Determine the safety, tolerability, pharmacokinetics, maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of VIP152 in patients with Chronic Lymphocytic Leukemia (CLL) or Richter Syndrome

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Male or female patients aged >/=18 years
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:

Active clinically serious infections of Grade > 2; requiring parenteral therapy
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

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

6

Study ID:

NCT04978779

Recruitment Status:

Terminated

Sponsor:

Vincerx Pharma, Inc.

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There are 5 Locations for this study

See Locations Near You

University of Cincinnati Medical Center
Cincinnati Ohio, 45219, United States
The Ohio State University
Columbus Ohio, 43210, United States
University of Texas Southwestern Medical Center
Dallas Texas, 75390, United States
Fred Hutchinson Cancer Research Center
Seattle Washington, 98109, United States
Pratia MCM Krakow
Kraków , 30-51, Poland

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

6

Study ID:

NCT04978779

Recruitment Status:

Terminated

Sponsor:


Vincerx Pharma, Inc.

How clear is this clinincal trial information?

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