Testing voruciclib alone or with venetoclax for B-cell cancers and AML
Phase 1, Open-label, Study of Voruciclib in Subjects With Relapsed and/or Refractory B Cell Malignancies or AML After Failure of Prior Standard Therapies and Voruciclib in Combination With Venetoclax in Subjects With Relapsed/Refractory AML
This study is testing if a new drug called voruciclib, alone or with another drug called venetoclax, can help people with tough-to-treat B-cell cancers and acute myeloid leukemia feel better.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | MEI Pharma, Inc. Industry-sponsored |
| Drugs / interventions | prednisone |
| Locations | 12 sites (Duarte, California and 11 other locations) |
| Trial ID | NCT03547115 on ClinicalTrials.gov |
What this trial studies
This Phase 1, open-label study aims to evaluate the safety and preliminary efficacy of voruciclib, both as a standalone treatment and in combination with venetoclax, for patients with relapsed or refractory B-cell malignancies and acute myeloid leukemia (AML). The study employs a dose escalation design, where participants will receive increasing doses of the treatment based on safety and tolerability assessments. Eligible patients must have previously failed standard therapies and have measurable disease. The goal is to identify effective dosing and potential therapeutic benefits of these drug combinations.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with relapsed or refractory B-cell malignancies or AML who have failed multiple prior treatments.
Not a fit: Patients with acute promyelocytic leukemia or those with a history of pneumonitis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with difficult-to-treat B-cell malignancies and AML.
How similar studies have performed: Other studies have shown promise with similar drug combinations, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Duarte, California and 11 other locations
- City of Hope — Duarte, California, United States (Recruiting)
- Northwestern Memorial Hospital — Chicago, Illinois, United States (Recruiting)
- Dana Farber Cancer Institute — Boston, Massachusetts, United States (Active_not_recruiting)
- Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
- University of Nebraska Medical Center — Omaha, Nebraska, United States (Recruiting)
- New York University — New York, New York, United States (Active_not_recruiting)
- Duke University — Durham, North Carolina, United States (Active_not_recruiting)
- Oregon Health and Science University — Portland, Oregon, United States (Recruiting)
- MD Anderson — Houston, Texas, United States (Recruiting)
- University of Virginia — Charlottesville, Virginia, United States (Recruiting)
- Swedish Cancer Institute — Seattle, Washington, United States (Active_not_recruiting)
- Froedtert Hospital & the Medical College of Wisconsin — Milwaukee, Wisconsin, United States (Recruiting)
Study contacts
- Study coordinator: MEI Pharma
- Email: Patients@meipharma.com
- Phone: 858-369-7100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.