Safety, Tolerability and Efficacy of A6 in Patients With Chronic Lymphocytic Leukemia (CLL)

• Status: Terminated
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will assess the efficacy, safety and pharmacodynamic markers of the study drug, A6, in patients with CLL and small lymphocytic lymphoma (SLL).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ångstrom Pharmaceuticals

Criteria

Inclusion Criteria:

• Confirmed diagnosis of CLL or SLL based on IWCLL Criteria

• Measurable or evaluable disease based on IWCLL criteria

• Previously untreated patients who have been counseled on approved alternative therapeutic options. Not a candidate for fludarabine/cyclophosphamide/rituximab (FCR) or has preference to not receive chemotherapy.

• Eastern Cooperative Oncology Group (ECOG) status of 0-2.

• Adequate bone marrow, renal, liver, cardiac and pulmonary function.

• Life expectancy of greater than or equal to 6 months.

Exclusion Criteria:

• Receipt of other cancer therapy, immunomodulatory drug therapy or immunosuppressive therapy within 4 weeks prior to 1st dose.

• Receipt of corticosteroids > 20 mg/day within 4 weeks prior to1st dose

• Major surgery or radiation within 4 weeks prior to 1st dose

• Presence of uncontrolled infection requiring systemic therapy

• Active second malignancy other than non-melanoma skin cancer

• Uncontrolled autoimmune anemia or thrombocytopenia

• Receipt of any investigational agent within 4 weeks prior to 1st dose

• Pregnant or lactating female

• Any severe, acute or chronic medical or psychiatric condition, or lab abnormality that may increase the risk associated with trial participation, study drug administration or interfere with informed consent process or compliance with requirements of the trial.