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:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-25 @ 3:27 AM
NCT ID:
NCT03719105
Eligibility Criteria:
Inclusion Criteria:
* Patients must weigh at least 10 kilograms at the time of the study enrollment.
* Diagnosis
Newly diagnosed patients with histologically proven mature T- and NK- cell neoplasms:
COHORT 1
* Aggressive NK cell leukemia (ICD-O code 9948/3)
* Extranodal NK/T-cell lymphoma, nasal type (ICD-O code 9719/3) COHORT 2
* Enteropathy-associated T-cell lymphoma (ICD-O code 9717/3)
* Hepatosplenic T-cell lymphoma (ICD-O code 9716/3)
* Peripheral T-cell lymphoma, non-otherwise specified (ICD-O code 9702/3)
* Angioimmunoblastic T-cell lymphoma (ICD-O code 9705/3)
* Other mature T- and NK-cell neoplasm histologies will considered after case-by-case discussion with Study Chairs and executive Vice-Chair Patients with lymphoma must have stage III or IV disease (See Appendix III for Staging).
* Organ Function Requirements
Adequate liver function defined as:
* Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age.
* ALT (SGPT) \< 3 x ULN for age.
Adequate cardiac function defined as:
* Shortening fraction of ≥ 27% by echocardiogram, or
* Ejection fraction of ≥ 50% by radionuclide angiogram.
Adequate pulmonary function defined as:
• Patients with a history of pulmonary dysfunction must have no evidence of dyspnea at rest, no exercise intolerance due to pulmonary insufficiency, and a pulse oximetry \> 92% while breathing room air unless current dysfunction is due to the lymphoma, in which case the patient is eligible.
Exclusion Criteria:
* Alk+ or Alk- Anaplastic Large Cell Lymphoma (ALCL)
* Patients with active CNS disease.
* Patients with stage I or stage II disease (See Appendix III for Staging).
* Patients who have received any prior cytotoxic chemotherapy for the current diagnosis of NHL.
* Previous steroid treatment and/or radiation treatment are not allowed unless they are used for emergency management. Patients who have received emergency irradiation and/or steroid therapy will be eligible only if started on protocol therapy not more than one week from the start of radiotherapy or steroids.
* Female patients who are pregnant. Pregnancy tests must be obtained in girls who are post menarchal.
* Lactating females, unless they have agreed not to breastfeed their infants.
* Patients with Down syndrome.
* Patients taking CYP3A4 substrates with narrow therapeutic indices. Patients (COHORT 2 ONLY) chronically receiving medications known to be metabolized by CYP3A4 and with narrow therapeutic indices (See Appendix V). The topical use of these medications (if applicable) is allowed.
* Patients taking CYP3A4 inhibitors. Patients (COHORT 2 ONLY) chronically receiving drugs that are known potent CYP3A4 inhibitors within 7 days prior to study enrollment (See Appendix V). The topical use of these medications (if applicable) is allowed.
* Patients taking CYP3A4 inducers. Patients (COHORT 2 ONLY) chronically receiving drugs that are known potent CYP3A4 inducers within 12 days prior to study enrollment (See Appendix V).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
31 Years
Study:
NCT03719105
Study Brief:
Protocol Section:
NCT03719105