Current Polivy Trials Open to Teenagers
Polivy (polatuzumab vedotin), an antibody-drug conjugate for relapsed or refractory diffuse large B-cell lymphoma (DLBCL), has no FDA approval for patients under 18. Adult trials (e.g., NCT02692952, NCT03264486) specify ages 18+.[1][2] However, some ongoing pediatric or adolescent-inclusive trials exist:
- NCT05040042 (pediatric lymphoma study): Enrolls ages 1-21 for relapsed/refractory B/NK-cell lymphomas, including DLBCL. Polivy is tested in combination with other agents. Eligibility requires specific disease subtypes and prior therapies; sites are active in the US and Europe.[3]
- NCT04557449 (pediatric CAR-T + Polivy arm): Targets ages 1-30 with high-risk B-cell lymphomas post-CAR-T failure. Open at multiple US centers; includes performance status and organ function criteria typical for adolescents.[4]
Check ClinicalTrials.gov for real-time status, as enrollment can close quickly.
Why Limited Teenager Access
Polivy trials historically exclude under-18s due to pharmacokinetics data focused on adults (≥18 years in pivotal GO29365 trial).[5] Pediatric extrapolation is challenging for lymphomas, which are rarer in kids/teens (incidence peaks 70+ years).[6] Sponsors like Roche/Genentech prioritize adult efficacy first, with pediatric expansion via FDA Pediatric Research Equity Act only after approval.
No completed pediatric Polivy trials show efficacy in teens yet; ongoing ones address this gap but represent <5% of total Polivy studies.
Age Cutoffs in Key Polivy Trials
| Trial ID | Indication | Age Range | Status | Notes |
|----------|------------|-----------|--------|-------|
| NCT02692952 (GO29365) | DLBCL | 18-80 | Completed | Basis for FDA approval; no peds. |
| NCT03671018 (POLARGO) | DLBCL | 18+ | Completed | European confirmatory; adults only. |
| NCT05040042 | Pediatric lymphoma | 1-21 | Recruiting | Includes teens; Polivy combo. |
| NCT04557449 | Post-CAR-T lymphoma | 1-30 | Recruiting | Adolescents eligible if qualified. |
How Teens Can Join or Alternatives
Teens (12-17) meeting criteria—like measurable DLBCL, ECOG 0-2, adequate labs—can screen for NCT05040042 or NCT04557449 via oncology centers (e.g., Children's Hospital of Philadelphia, Memorial Sloan Kettering).[3][4] Compassionate use or expanded access is rare for Polivy without pediatric data.
Alternatives for teen DLBCL: CAR-T (e.g., Yescarta trials NCT04684563, ages 18+ but pediatric versions exist), bispecifics like glofitamab (NCT05099142, 12+), or standard chemo (R-CHOP).[7] Consult NCCN pediatric guidelines or COG for non-trial options.
Regulatory Timeline for Broader Teen Access
No pediatric exclusivity granted yet. If NCT05040042 succeeds, label expansion could occur by 2026-2027 via FDA review. EU similar via EMA PIP compliance. No patent issues block peds (Polivy patents expire 2030s).8
Sources
[1]: ClinicalTrials.gov NCT02692952
[2]: ClinicalTrials.gov NCT03264486
[3]: ClinicalTrials.gov NCT05040042
[4]: ClinicalTrials.gov NCT04557449
[5]: Polivy Prescribing Information (Genentech, 2023)
[6]: SEER Cancer Statistics (NCI)
[7]: ClinicalTrials.gov NCT05099142