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 @ 7:15 PM
Ignite Modification Date:
2025-12-24 @ 7:15 PM
NCT ID:
NCT01882803
Eligibility Criteria:
Inclusion Criteria:
* Participants who had been diagnosed with iNHL that had progressed.
* Participants must have exhibited lack of CR or progressive disease (PR) or progression within 6 months after the last dose of a chemotherapy induction regimen or RIT.
* Participants must have had rituximab-refractory disease, defined as lack of CR or PR or PD within 6 months of last dose.
* Measurable disease with a lymph node or tumor mass ≥1.5 centimeters in at least one dimension by computed tomography (CT), positron emission tomography/CT or magnetic resonance imaging.
* Adequate renal and hepatic function.
Exclusion Criteria:
* Candidate for potentially curative therapies in the opinion of the investigator.
* Previous treatment with a PI3K inhibitor or Bruton's tyrosine kinase inhibitor.
* Prior history of allogeneic hematopoietic stem cell transplant.
* Prior chemotherapy, cancer immunosuppressive therapy, or other investigational agents within 4 weeks before first dose of study drug.
* Grade 3B FL and/or clinical evidence of transformation to a more aggressive subtype of lymphoma.
* Symptomatic central nervous system NHL.
* Ongoing systemic bacterial, fungal, or viral infections at the time of initiation of study treatment.
* Prior, current, or chronic hepatitis B or hepatitis C infection, positive result for hepatitis C virus antibodies, hepatitis B surface antigen, or hepatitis B core antibodies.
* History of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within the last 6 months prior to first dose of study drug.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01882803
Study Brief:
Protocol Section:
NCT01882803