A Phase 1 Study of Voruciclib in Subjects With B-Cell Malignancies or AML
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 63
Summary
- Conditions
- Acute Myeloid Leukemia (AML)
- Chronic Lymphocytic Leukemia (CLL)
- Diffuse Large B Cell Lymphoma (DLBCL)
- Follicular Lymphoma ( FL)
- Mantle Cell Lymphoma (MCL)
- Marginal Zone Lymphoma (MZL)
- Small Lymphocytic Lymphoma (SLL)
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: This is a Phase 1, open-label, 3 + 3 dose escalation study to determine the safety and preliminary efficacy of voruciclib.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
This is a Phase 1, open-label, 3 + 3 dose escalation study to determine the safety and preliminary efficacy of voruciclib in subjects with relapsed/refractory B cell malignancies and AML after treatment with standard therapy. Escalation to the next higher dose level will depend on demonstrated safet...
This is a Phase 1, open-label, 3 + 3 dose escalation study to determine the safety and preliminary efficacy of voruciclib in subjects with relapsed/refractory B cell malignancies and AML after treatment with standard therapy. Escalation to the next higher dose level will depend on demonstrated safety and tolerability at each dose level. Subjects may continue to receive voruciclib while there is evidence of clinical benefit and acceptable toxicity as judged by the investigator.
Tracking Information
- NCT #
- NCT03547115
- Collaborators
- Not Provided
- Investigators
- Not Provided