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

Trial Status: Active

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.

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:
  • Acute promyelocytic leukemia
  • 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:
  • Prior to the start of voruciclib therapy, subjects may be using systemic corticosteroids (≤20 mg/day of prednisone or equivalent), topical, or inhaled corticosteroids
  • During study therapy, subjects may use systemic, topical, or enteric corticosteroids, if needed

California

Duarte
City of Hope Comprehensive Cancer Center
Status: ACTIVE

Illinois

Chicago
Northwestern University
Status: ACTIVE

Massachusetts

Boston
Dana-Farber Cancer Institute
Status: ACTIVE

Minnesota

Rochester
Mayo Clinic in Rochester
Status: ACTIVE

Nebraska

Omaha
University of Nebraska Medical Center
Status: ACTIVE

New York

New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: ACTIVE

North Carolina

Durham
Duke University Medical Center
Status: ACTIVE

Oregon

Portland
OHSU Knight Cancer Institute
Status: ACTIVE

Texas

Houston
M D Anderson Cancer Center
Status: APPROVED

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.

Trial Phase Phase I

Trial Type Treatment

Lead Organization
MEI Pharma Inc

  • Primary ID ME-522-001
  • Secondary IDs NCI-2018-01350
  • Clinicaltrials.gov ID NCT03547115