- Clinical and phenotypic verification of B cell CLL and measurable disease. Immunophenotyping of the leukemic cells (blood or marrow) must demonstrate a monoclonal (or light chain positive) B cell population with immunophenotype consistent with CLL (e.g., co-expressing CD19 and CD5).
- Recovered from toxic effects attributed to UC-961 to grade 1 levels, or baseline.
- Must have measurable disease, including one of the following:
- absolute lymphocyte count greater than 5000/uL
- lymphadenopathy greater than 1.5 cm in longest dimension
- bone marrow biopsy with residual CLL cells, or resultant bone marrow dysfunction
- Women of childbearing potential must agree not to become pregnant for the duration of the study. Both men and women must agree to use a barrier method of contraception for the duration of the study and until 10 weeks after the final dose of UC-961.
- Subjects must have an ECOG performance status of 0-2.
- Adequate hematologic function
- Adequate renal function
- Adequate hepatic function
- Adequate coagulation tests
- Pregnant or breast-feeding women
- Intervening therapy since completion of initial UC-961 dosing, but excluding the following:
- Within 14 days, or 5 half-lives (if known), whichever is shorter, of UC-961 restart: small molecule kinase inhibitor (eg: ibrutinib, idelalisib, AVL-292, IPI-145);
- Within 28 days of UC-961 restart: chemotherapy (e.g., purine analogues, alkylating agents), corticosteroids, radiation therapy, or participation in any other investigational drug treatment (besides UC-961);
- Within 56 days UC-961 restart: previous UC-961 dosing;
- Within 8 weeks of UC-961 restart: monoclonal antibody therapy directed against CLL (eg. rituximab, ofatumumab, obinutuzumab, alemtuzumab).
- Current infection requiring parenteral antibiotics.
- Active infection with HIV, HBV, or HCV.
- Concurrent malignancy or prior malignancy within the previous 3 years (other than completely resected carcinoma in situ, prostate cancer, or localized non-melanoma skin cancer).
- Known central nervous system (CNS) involvement by malignancy.
- Untreated autoimmunity such as autoimmune hemolytic anemia, or immune thrombocytopenia.
- Uncompensated hypothyroidism (defined as TSH greater than 2x upper limit of normal not treated with replacement hormone).
- Presence of more than 55% pro-lymphocytes in peripheral blood. Patients with Richter's transformation are not excluded.
- Insufficient recovery from surgical-related trauma or wound healing.
- Impaired cardiac function.
|Maximum Eligible Age:||N/A|
|Minimum Eligible Age:||18 Years|