Safety, Tolerability and Efficacy of A6 in Patients With Chronic Lymphocytic Leukemia (CLL)
This study will assess the efficacy, safety and pharmacodynamic markers of the study drug, A6, in patients with CLL and small lymphocytic lymphoma (SLL).
|Condition or Disease||Intervention/Treatment||Phase|
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.
Arms and Interventions
A6 is administered subcutaneously two times a day for 6 cycles (1 cycle = 28 days).
A6 is self-administered subcutaneously two times a day for 6 cycles (1 cycle = 28 days).
Primary Outcome Measures
- Overall response rate [Assessed at Day 28 of Cycle 6]
International Workshop on Chronic Lymphocytic Lymphoma (IWCLL) Guidelines for response of clinical, hematological, and bone marrow features.
Secondary Outcome Measures
- Safety of A6 [Throughout 6 Cycles (6 months)]
Nature and frequency of adverse events
- Determine IWCLL response rate in the Intent-To-Treat Population [Throughout 6 Cycles (6 months)]
- Determine the response in patients who received all 6 cycles of A6 [6 months]
- Determine progression-free survival [Throughout 6 Cycles (6 months)]
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.
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.
Contacts and Locations
|1||Moores Cancer Center, UCSD||La Jolla||California||United States||92093|
Sponsors and Collaborators
- Ångstrom Pharmaceuticals
- Principal Investigator: Michael Choi, MD, Moores Cancer Center, UCSD
Study Documents (Full-Text)None provided.