A Phase 1, Dose-Escalation Study of CNF2024 Administered Orally to Patients With B Cell Chronic Lymphocytic Leukemia (CLL)
Inclusion Criteria:
- Patients with CLL who relapsed following or are intolerant to purine analog -based
therapy
- Hemoglobin >=9 gm/dL (may be post-transfusion)
- Total bilirubin <2 X ULN, and ALT and AST <2 x ULN
- Creatinine <=2 X ULN
- Normal plasma cortisol and ACTH concentrations
- ECOG Performance Status <=2
- Anticipated survival >=3 months
- For men and women of child-producing potential, use of effective contraceptive
methods during the study and for one month after treatment
- Ability to understand the requirements of the study, provide written informed consent
and authorization of use and disclosure of protected health information, and agree to
abide by the study restrictions and return for the required assessments
Exclusion Criteria:
- Pregnant or nursing women
- Treatment with chemotherapy, monoclonal antibody, or radiotherapy within 28 days
before entering the study
- Participation in any investigational drug study within 28 days before CNF2024
administration
- Patients with secondary malignancy requiring active treatment (except hormonal
therapy)
- Active symptomatic bacterial, fungal, or viral infection including active HIV or
viral (A, B, or C) hepatitis
- Problems with swallowing or malabsorption
- Diarrhea (excess of 2-3 stools/day above normal frequency in the past month)
- Gastrointestinal diseases including gastritis, ulcerative colitis, Crohn's disease,
or hemorrhagic coloproctitis
- Major surgery of the stomach or small intestine
- Adrenal dysfunction
- Patients with life- or function-threatening CLL complications (e.g., cord
compression, hemolytic crisis, urinary tract obstruction)
- Any illness or condition that in the opinion of the investigator may affect safety of
treatment or evaluation of any the study's endpoints