Clinical trial · Interventional
Brentuximab for Newly Diagnosed Hodgkin Disease
A Pilot Study of Risk Adapted Therapy Utilizing Upfront Brentuximab With Combination Chemotherapy in the Treatment of Children, Adolescents and Young Adults With Newly Diagnosed Hodgkin Lymphoma
NCT02398240CI-TRIAL-00070812completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The addition of Brentuximab vedotin (Bv) to combination chemotherapy will be safe, well tolerated and effective in children, adolescents and young adults with all stages of newly diagnosed Hodgkin lymphoma (HL).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hodgkin Lymphoma | Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Brentuximab Vedotin | Drug | Brentuximab Vedotin | ALIAS |
| Doxorubicin | Drug | Doxorubicin | ALIAS |
| Rituximab | Drug | Rituximab | ALIAS |
| Vincristine | Drug | Vincristine | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Low Risk
- description
- Low Risk Patients (Stage IA, IIA; no bulky disease or extension): 3 cycles of chemotherapy
- interventionNames
- Drug: Brentuximab Vedotin
- Drug: Doxorubicin
- Drug: Vincristine
- type
- EXPERIMENTAL
- label
- Intermediate Risk
- description
- Intermediate Risk Patients (Stage IA bulk/E, IB, IIA bulk/E, IIB, IIIA): 4 cycles of chemotherapy
- interventionNames
- Drug: Brentuximab Vedotin
- Drug: Doxorubicin
- Drug: Vincristine
- Drug: Rituximab
- type
- EXPERIMENTAL
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 29 Years
Show eligibility criteria text
Inclusion Criteria: * Normal Serum creatinine based on age or creatinine clearance \>60 ml/min/1.73 m2 or an equivalent radioisotope glomerular filtration rate (GFR) as determined by the institutional normal range. * Direct bilirubin \< 1.5 upper limit of normal (ULN) for age, and SGOT (AST) or SGPT (ALT) \<3 x ULN * Shortening fraction \>27% by echocardiogram, or * Ejection fraction of \>50% by radionuclide angiogram or echocardiogram. * For patients age 1-16 years, Lansky score of ≥60. * For patients \> 16 years, Karnofsky score of ≥60. * No prior Hodgkin lymphoma directed therapy is allowed except for emergent mediastinal irradiation (\<1000cGy) for superior vena cava (SVC) syndrome. Exclusion Criteria: * Females who are pregnant (positive HCG) or lactating. * Karnofsky \<60% or Lansky \<60% if less than 16 years of age. * Age ≤1 year or \>29.99 years of age.
References
Publications (1)
- BACKGROUNDHochberg J, Basso J, Shi Q, Klejmont L, Flower A, Bortfeld K, Harrison L, van de Ven C, Moorthy C, Islam H, Gerard P, Voss S, Cairo MS. Risk-adapted chemoimmunotherapy using brentuximab vedotin and rituximab in children, adolescents, and young adults with newly diagnosed Hodgkin's lymphoma: a phase II, non-randomized controlled trial. J Immunother Cancer. 2022 May;10(5):e004445. doi: 10.1136/jitc-2021-004445. PMID 35584865