Current Age Eligibility for Polivy Trials
Polivy (polatuzumab vedotin), approved for adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), has clinical trials that generally restrict enrollment to adults aged 18 and older. No active or completed trials explicitly include teenagers (under 18) as participants.[1][2]
Why Teens Are Typically Excluded
Pediatric trials for oncology drugs like Polivy require separate studies under regulations like the FDA's BEST Pharmaceuticals for Children Act or EMA pediatric investigation plans. Polivy's development focused on adults due to DLBCL rarity in children and lack of pediatric-specific data. Trials like GO29365 (Phase 1b/2) and POLARIX (Phase 3) specified adults ≥18 years.[2][3]
Ongoing or Relevant Pediatric Lymphoma Trials
No Polivy trials target adolescents, but related CAR-T and bispecific antibody studies for pediatric/young adult lymphomas (e.g., NCT04684563 for lisocabtagene maraleucel) sometimes include ages 12-17. Teens with DLBCL might access Polivy via compassionate use or expanded access, not standard trials.[4]
How Teens or Parents Can Check Eligibility
Search ClinicalTrials.gov using "polivy" + "adolescent" or "pediatric" filters; results show zero matches for under-18 inclusion. Contact trial sponsors like Genentech/Roche or sites via the listing's contact info. Eligibility often hinges on tumor type, prior treatments, and ethics board approval for minors.[1]
Alternatives for Teen Lymphoma Patients
For adolescents with aggressive lymphomas:
- Approved options: R-CHOP or similar regimens (not Polivy).
- Trials: Pediatric MATCH (NCT03155620) or ITCC-101 for novel agents in kids/teens.
Consult a pediatric oncologist; off-label adult drug use in teens occurs rarely under IRB oversight.[5]
[1]: ClinicalTrials.gov search for Polivy trials
[2]: Polivy prescribing information (Genentech)
[3]: POLARIX trial details (NEJM)
[4]: ClinicalTrials.gov pediatric lymphoma trials
[5]: NCI Pediatric Oncology Branch