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


About this study

The purpose of this study is to determine the safety and preliminary efficacy of voruciclib as monotherapy in subjects with relapsed or refractory B-cell malignancies or AML, and in combination with venetoclax in subjects with relapsed or refractory 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

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

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

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

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 10/6/22. Questions regarding updates should be directed to the study team contact.

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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