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A Study of Voruciclib Alone or in Combination With Venetoclax in Subjects With B-Cell Malignancies or AML

NCT03547115 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2026-03-17

No results posted yet for this study

Summary

This is a Phase 1, open-label, dose escalation study to determine the safety and preliminary efficacy of voruciclib monotherapy in subjects with relapsed/refractory B cell malignancies or AML after failure of standard therapies or voruciclib in combination with venetoclax in subjects with relapsed or refractory AML

Conditions

  • Follicular Lymphoma (FL)
  • Mantle Cell Lymphoma (MCL)
  • Marginal Zone Lymphoma (MZL)
  • Small Lymphocytic Lymphoma (SLL)
  • Chronic Lymphocytic Leukemia (CLL)
  • Diffuse Large B-cell Lymphoma (DLBCL)
  • Acute Myeloid Leukemia (AML)

Interventions

DRUG

voruciclib monotherapy

Voruciclib will be administered orally

DRUG

voruciclib and venetoclax

Voruciclib and Venetoclax will be administered orally

Sponsors & Collaborators

  • MEI Pharma, Inc.

    lead INDUSTRY

Principal Investigators

  • Richard Ghalie, MD · MEI Pharma

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-31
Primary Completion
2024-07-24
Completion
2024-07-24
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03547115 on ClinicalTrials.gov