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
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
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There are 5 Locations for this study
Cincinnati Ohio, 45219, United States More Info
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Dallas Texas, 75390, United States More Info
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Seattle Washington, 98109, United States More Info
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