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

Ångstrom Pharmaceuticals

Status and phase

Terminated

Phase 2

Conditions

CLL

SLL

Small Lymphocytic Lymphoma

Chronic Lymphocytic Leukemia

Treatments

Drug: A6

Study type

Interventional

Funder types

Industry

Identifiers

NCT02046928

A6-005

Details and patient eligibility

About

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

Full description

In patients diagnosed with CLL or SLL, study medication will be injected subcutaneously two times a day in an outpatient setting for up to 6 cycles (28 days = 1 cycle) prior to the primary endpoint assessment.

Enrollment

5 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.