Clinical Trials

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

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.