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

Launched by MEI PHARMA, INC. · May 24, 2018

Keywords

ClinConnect Summary

This clinical trial is studying a medication called voruciclib, both on its own and in combination with another drug called venetoclax, to see how safe and effective they are for patients with certain types of blood cancers, including various lymphomas and acute myeloid leukemia (AML). The trial is for adults aged 18 and older whose cancer has not responded to previous treatments and who need new options. Participants should have a confirmed diagnosis of one of the specified blood cancers and measurable disease, which means their cancer can be observed and tracked.

If you join this study, you will receive either voruciclib alone or in combination with venetoclax to assess how well these treatments work and monitor any side effects. It’s important to note that there are specific health conditions that might exclude you from participating, such as serious heart diseases or certain infections. The trial is currently recruiting, and it aims to provide new hope for patients with relapsed or difficult-to-treat blood cancers.

Gender

ALL

Eligibility 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
• • Symptomatic/uncontrolled HIV infection/AIDS, or currently taking contraindicated medications for HIV control
• * Ongoing immunosuppressive treatment including calcineurin inhibitors at the time of the start of study treatment, including systemic or enteric corticosteroids except as follows:
• • 1. Prior to the start of study treatment, 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