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

Overview

About this study

The purpose of this study is to determine the safety and preliminary effiectiveness of voruciclib in subjects with relapsed/refractory B cell malignancies or AML after treatment with standard therapy.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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:
    • 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:

  • 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.
  • 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,

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Kebede Begna, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

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More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20493092

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