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 @ 6:34 PM
Ignite Modification Date:
2025-12-24 @ 6:34 PM
NCT ID:
NCT03372057
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥ 18 years of age
2. Diagnosis of one of the following histologic subtypes of PTCL, pathologically confirmed, as defined by the World Health Organization:
1. Peripheral T-cell lymphoma-not otherwise specified;
2. Angioimmunoblastic T-cell lymphomas;
3. Anaplastic large cell lymphoma (ALCL); or
4. Natural-killer/T-cell lymphoma
3. Received at least 2 cycles of one standard regimen for newly diagnosed advanced PTCL, and one of the following:
1. failed to achieve at least a PR after 2 or more cycles of standard therapy;
2. failed to achieve a CR after completion of standard therapy; and/or
3. persistent or progressive disease after an initial response
4. For participants with CD30+ ALCL, failed or are ineligible or intolerant to brentuximab vedotin
5. Measurable disease as defined by Lugano for PTCL, that is, at least 1 measurable disease lesion \> 1.5 centimeters in at least one dimension by conventional techniques (fluorine-18 fluorodeoxyglucose positron emission tomography/computed tomography \[CT\], CT with contrast, magnetic imaging resonance)
Exclusion Criteria:
1. Primary leukemic PTCL subtypes (that is, T-cell prolymphocytic leukemia, T-cell large granular lymphocytic leukemia, adult T-cell leukemia/lymphoma and aggressive NK-cell leukemia) or transformed mycosis fungoides
2. Received prior allogeneic transplant
3. Received prior treatment with a PI3K inhibitor
4. Known central nervous system involvement by PTCL
5. Ongoing treatment with chronic immunosuppressants (e.g., cyclosporine) or systemic steroids \> 20 mg of prednisone (or equivalent) once daily
6. Ongoing treatment for systemic bacterial, fungal, or viral infection at Screening
7. Known hypersensitivity to duvelisib and/or its excipients
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03372057
Study Brief:
Protocol Section:
NCT03372057