Safety, Tolerability and Efficacy of A6 in Patients With Chronic Lymphocytic Leukemia (CLL)
Status: | Recruiting |
---|---|
Conditions: | Blood Cancer, Lymphoma |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | February 2014 |
End Date: | December 2016 |
Contact: | Kimberly Aguilar |
Email: | k1aguilar@ucsd.edu |
Phone: | 858-534-5201 |
A Phase 2 Trial to Determine the Safety, Tolerability, and Efficacy of A6, a CD44 Binding Peptide, for the Treatment of Patients With Chronic Lymphocytic Leukemia
This study will assess the efficacy, safety and pharmacodynamic markers of the study drug,
A6, in patients with CLL and small lymphocytic lymphoma (SLL).
A6, in patients with CLL and small lymphocytic lymphoma (SLL).
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.
times a day in an outpatient setting for up to 6 cycles (28 days = 1 cycle) prior to the
primary endpoint assessment.
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.
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