Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2025-12-24 @ 10:32 PM
NCT ID:
NCT01292135
Eligibility Criteria:
Inclusion Criteria:
1. Histologically confirmed CLL or SLL and satisfying at least 1 of the following criteria for requiring treatment:
* Progressive splenomegaly and/or lymphadenopathy identified by physical examination or radiographic studies
* Anemia (\<11 g/dL) or thrombocytopenia (\<100,000/μL) due to bone marrow involvement
* Presence of unintentional weight loss \> 10% over the preceding 6 months
* NCI CTCAE Grade 2 or 3 fatigue
* Fevers \> 100.5° or night sweats for \> 2 weeks without evidence of infection
* Progressive lymphocytosis with an increase of \> 50% over a 2 month period or an anticipated doubling time of \< 6 months
2. 1 to 3 prior treatment regimens for CLL/SLL
3. ECOG performance status of ≤ 1
4. ≥ 18 years of age
5. Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty
6. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (in accordance with national and local subject privacy regulations)
Exclusion Criteria:
1. Any chemotherapy, therapeutic antineoplastic antibodies (not including radio- or toxin immunoconjugates), radiation therapy, or experimental antineoplastic therapy within 4 weeks of first dose of study drug
2. Radio- or toxin-conjugated antibody therapy within 10 weeks of first dose of study drug
3. Concomitant use of medicines known to cause QT prolongation or torsades de pointes
4. Transformed lymphoma or Richter's transformation Any life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of PCI-32765 PO, or put the study outcomes at undue risk
5. Any of the following laboratory abnormalities: oAbsolute neutrophil count (ANC) \< 1000 cells/mm3 (1.0 x 109/L) oPlatelet count \< 50,000/mm3 (50 x 109/L) oSerum aspartate transaminase (AST/SGOT) or alanine transaminase (ALT/SGPT) ≥ 3.0 x upper limit of normal (ULN) oCreatinine \> 2.0 x ULN or creatinine clearance \< 40 mL/min
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01292135
Study Brief:
Protocol Section:
NCT01292135