A Phase 1 Study of Voruciclib in Subjects With B-Cell Malignancies or AML

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: MEI Pharma, Inc.
• Treatments: Voruciclib

Criteria

Inclusion Criteria:

• Age ≥18 years

• Histologically-confirmed diagnosis of 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), or AML

a. Subjects must have disease that has relapsed or is refractory to 2 or more prior regimens and in need of treatment due to progressive disease

• Presence of measurable disease defined per the 2008 International workshop on CLL guidelines, or by 2014 Lugano criteria for non-Hodgkin lymphoma (does not apply for AML subjects)

• Adequate hematologic parameters unless clearly due to the disease under study

• Adequate renal and hepatic function, per laboratory reference range at screening

Exclusion Criteria:

• History of pneumonitis of any cause

• For CLL subjects: only known histological transformation to an aggressive lymphoma

• For AML subjects:

1. Acute promyelocytic leukemia

2. Peripheral blast count > 25 × 10 9/L

• Known central nervous system involvement

• Significant cardiovascular disease

• Significant screening ECG abnormalities

• Subjects who require warfarin, anti-cancer therapeutics or investigational agents

• Evidence of an ongoing systemic bacterial, fungal, or viral infection (including upper respiratory tract infections) at the time of start of voruciclib therapy

• Prior solid organ transplantation

• Receipt of an allogeneic transplant within 6 months or an autologous transplant within the preceding 3 months; evidence of ongoing graft-versus-host disease (GVHD)

• Prior therapy with a cyclin-dependent kinase (CDK9) inhibitor

• Ongoing immunosuppressive treatment at the time of the start of voruciclib therapy, including systemic or enteric corticosteroids except as follows:

1. Prior to the start of voruciclib therapy, subjects may be using systemic corticosteroids (≤20 mg/day of prednisone or equivalent), topical, or inhaled corticosteroids

2. During study therapy, subjects may use systemic, topical, or enteric corticosteroids, if needed