Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03755804 | Pediatric Classical Hodgkin Lymphoma Consortium Study: cHOD17 | PHASE2 | ACTIVE NOT_RECRUITING | 232 | — | — | Dec 12, 2018 | Jul 1, 2028 | Apr 23, 2026 | 8 | United States |
The 70 evaluable low-risk patients enrolled will be evaluated for this objective.
Time to event defined as relapse, progression or death. The 115 evaluable high-risk patients participants enrolled will be evaluated for this objective.
| Arm | Type | Description |
|---|---|---|
| Low-Risk | EXPERIMENTAL | Participants receive 2 cycles of BEABOVP: bendamustine, etoposide, Adriamycin® (doxorubicin), bleomycin, Oncovin® (vincristine), vinblastine and prednisone. Filgrastim may be given as clinically indicated. Dexrazoxane may be given at the discretion of the treating investigator. Residual node radiotherapy will be given at the end of all chemotherapy only to involved nodes that do not have an AR after 2 cycles of therapy. Quality of Life measurements may be done. |
| Intermediate-Risk | EXPERIMENTAL | Participants receive 3 cycles of BEABOVP: bendamustine, etoposide, Adriamycin® (doxorubicin), bleomycin, Oncovin® (vincristine), vinblastine and prednisone. For patients with an AR after 2 cycles of therapy, steroids will be omitted from their subsequent cycles of therapy. Filgrastim may be given as clinically indicated. Dexrazoxane may be given at the discretion of the treating investigator. Residual node radiotherapy will be given at the end of all chemotherapy only to involved nodes that do not have an AR after 2 cycles of therapy. Quality of Life measurements may be done. |
| High-Risk | EXPERIMENTAL | Participants receive 2 cycles of AEPA: Adcedris® (brentuximab vedotin), etoposide, prednisone and Adriamycin® (doxorubicin) and 4 cycles of CAPDac: cyclophosphamide, Adcetris® (brentuximab vedotin), prednisone and Dacarbazine® (DTIC). For patients with an AR after 2 cycles of therapy, steroids will be omitted from their subsequent cycles of therapy. Filgrastim may be given as clinically indicated. Dexrazoxane may be given at the discretion of the treating investigator. Residual node radiotherapy will be given at the end of all chemotherapy only to involved nodes that do not have an AR after 2 cycles of therapy. Quality of Life measurements may be done. |
| Name | Type | Description |
|---|---|---|
| bendamustine | DRUG | Given intravenously (IV) |
| Etoposide | DRUG | Given intravenously (IV) |
| Doxorubicin | DRUG | Given intravenously (IV) |
| Bleomycin | DRUG | Given intravenously (IV) |
| Vincristine | DRUG | Given intravenously (IV) |
| Vinblastine | DRUG | Given intravenously (IV) |
| Prednisone | DRUG | Given orally (PO) |
| Filgrastim | DRUG | Given subcutaneously (SQ) or IV |
| Brentuximab Vedotin | DRUG | Given intravenously (IV) |
| Cyclophosphamide | DRUG | Given intravenously (IV) |
| DTIC | DRUG | Given intravenously (IV) |
| Quality of Life Measurements | OTHER | Quality of Life measurements may be done in low-risk cycles 1 and 2 BEABOVP, intermediate-risk cycles 1, 2 and 3 BEABOVP and high-risk cycles 1 and 2 AEPA and cycles 1, 2, 3, and 4 CAPDac. QOL may be done at year 1, 2 and 5 for all risk groups. |
| Radiotherapy | RADIATION | Residual node radiotherapy will be given at the end of all chemotherapy only to involved nodes that do not have an AR after 2 cycles of therapy for all risk groups. Radiotherapy will be administered after completion of all chemotherapy upon hematologic count recovery. |
Inclusion Criteria: * Histologically confirmed, previously untreated CD30+ classical HL. (Participants are still eligible if they received limited emergent RT or steroid therapy - maximum of 7 days if within the last month or as approved by PI). * Age ≤ 21 years at the time of diagnosis (i.e., part...