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

Patients with a histologically or cytologically:

Confirmed CLL who are refractory to or have progressed from 2 or more regimens including BTKi and venetoclax or
Confirmed CLL transformed to DLBCL (Richter Syndrome) who have relapsed after, or been refractory, to at least 1 prior line of therapy for the DLBCL and having MYC overexpression/amplification/translocation
Adequate bone marrow, liver, and renal functions
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2

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:

54

Study ID:

NCT04978779

Recruitment Status:

Recruiting

Sponsor:

Vincerx Pharma, Inc.

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There are 5 Locations for this study

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University of Cincinnati Medical Center
Cincinnati Ohio, 45219, United States More Info
Research Site
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The Ohio State University
Columbus Ohio, 43210, United States More Info
Research Site
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University of Texas Southwestern Medical Center
Dallas Texas, 75390, United States More Info
Research site
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Fred Hutchinson Cancer Research Center
Seattle Washington, 98109, United States More Info
Research site
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Pratia MCM Krakow
Kraków , 30-51, Poland More Info
Research Site
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How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

54

Study ID:

NCT04978779

Recruitment Status:

Recruiting

Sponsor:


Vincerx Pharma, Inc.

How clear is this clinincal trial information?

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