Clinical trial · Interventional
Brentuximab Vedotin Combined With AVD Chemotherapy in Patients With Newly Diagnosed Early Stage, Unfavorable Risk Hodgkin Lymphoma
A Pilot Study of Brentuximab Vedotin Combined With AVD Chemotherapy in Patients With Newly Diagnosed Early Stage, Unfavorable Risk Hodgkin Lymphoma
NCT01868451CI-TRIAL-00113723completedN/AClinicalTrials.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 purpose of this study is to compare the outcomes across the 4 different treatment groups. The investigators hope that this treatment will improve the ability to cure more patients with HL and also limit the long-term side effects from the treatment. Although eliminating radiation in cohort 4 will eliminate the risk for long-term side effects from radiation, it is also possible that with BV+AVD chemotherapy alone there may be an increased risk of the Hodgkin lymphoma coming back after initial treatment.
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 (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Brentuximab vedotin (SGN-35) | Drug | Brentuximab Vedotin | ALIAS |
| consolidation volume RT (CVRT) | Radiation | — | UNRESOLVED |
| Dacarbazine | Drug | Dacarbazine | ALIAS |
| Doxorubicin HCL | Drug | Doxorubicin | ALIAS |
| Interim PET | Procedure | — | UNRESOLVED |
| Involved-Site Radiation Therapy (ISRT) | Radiation | — | UNRESOLVED |
| Vinblastine Sulfate | Drug | Vinblastine | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Cohort 1 (completed accrual)
- description
- Patients received 4 cycles of brentuximab vedotin \& AVD chemotherapy. Brentuximab vedotin, 1.2 mg/kg, will be administered on days 1 and 15 of each 28 day cycle. Doxorubicin 25 mg/m2, Vinblastine 6 mg/m2, \& Dacarbazine 375 mg/m2 will be administered on days 1 and 15 of each 28 day cycle. This may be followed by 30 Gy involved site radiotherapy. Involved site radiotherapy should be initiated from 12 days to 42 days after completion of chemotherapy. It is mandatory to administer prophylactic growth factor support starting with cycle 1. Choice of growth factor and dosing can be determined at the discretion of the treating physican.
- interventionNames
- Drug: Brentuximab vedotin (SGN-35)
- Drug: Doxorubicin HCL
- Drug: Vinblastine Sulfate
- Drug: Dacarbazine
- Radiation: Involved-Site Radiation Therapy (ISRT)
- Procedure: Interim PET
- type
- EXPERIMENTAL
- label
- Cohort 2
- description
- Patients with early stage, unfavorable risk Hodgkin lymphoma. The definition of disease bulk, one of the unfavorable risk features, has been updated, and is defined as the presence of any lymph node mass with transverse maximal diameter \> 7.0 cm OR coronal maximal diameter \> 7.0 cm. Patients will receive 4 cycles of brentuximab vedotin \& AVD chemotherapy. Brentuximab vedotin, 1.2 mg/kg, will be administered on days 1 and 15 of each 28 day cycle. Doxorubicin 25 mg/m2, Vinblastine 6 mg/m2, and Dacarbazine 375 mg/m2 will be administered on days 1 \& 15 of each 28 day cycle. This may be followed by 20 Gy involved site radiotherapy.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologic diagnosis of classical, CD30 positive Hodgkin lymphoma confirmed at enrolling institution * FDG-avid disease by FDG-PET/CT and measurable disease of at least 1.5 cm by CT * Ann Arbor Stage I or II disease * Disease bulk defined as any lymph node mass with transverse maximal diameter \> 7.0 cm OR coronal maximal diameter \> 7.0 cm on CT imaging * Females of childbearing age must be on an acceptable form of birth control per institutional standards * Ages 18 and over Exclusion Criteria: * Cardiac ejection fraction ≤ 50% * Hemoglobin-adjusted diffusing capacity for carbon monoxide \< 40% * ANC≤1000/μl and Platelets≤75,000/μl * Total bilirubin ≥ 2.0 mg/dl in the absence of a history of Gilbert's disease * Serum creatinine clearance of \<30 mL/min as estimated by the Cockcroft-Gault Method * Known pregnancy or breast-feeding * Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) * Medical illness unrelated to Hodgkin Lymphoma, which, in the opinion of the attending physician and/or MSKCC principal investigator, makes participation in this study inappropriate. * Peripheral neuropathy \> grade 1 * Patients receiving chronic treatment with systemic steroids. However, patients can receive up to 10 days of steroid therapy prior to starting treatment with BV+AVD.
References
Publications (3)
- DERIVEDGoldkuhle M, Kreuzberger N, von Tresckow B, Eichenauer DA, Specht L, Monsef I, Skoetz N. Chemotherapy alone versus chemotherapy plus radiotherapy for adults with early-stage Hodgkin's lymphoma. Cochrane Database Syst Rev. 2024 Dec 2;12(12):CD007110. doi: 10.1002/14651858.CD007110.pub4. PMID 39620432
- DERIVEDKumar A, Casulo C, Advani RH, Budde E, Barr PM, Batlevi CL, Caron P, Constine LS, Dandapani SV, Drill E, Drullinsky P, Friedberg JW, Grieve C, Hamilton A, Hamlin PA, Hoppe RT, Horwitz SM, Joseph A, Khan N, Laraque L, Matasar MJ, Moskowitz AJ, Noy A, Palomba ML, Schoder H, Straus DJ, Vemuri S, Yang J, Younes A, Zelenetz AD, Yahalom J, Moskowitz CH. Brentuximab Vedotin Combined With Chemotherapy in Patients With Newly Diagnosed Early-Stage, Unfavorable-Risk Hodgkin Lymphoma. J Clin Oncol. 2021 Jul 10;39(20):2257-2265. doi: 10.1200/JCO.21.00108. Epub 2021 Apr 28. PMID 33909449
- DERIVEDKumar A, Casulo C, Yahalom J, Schoder H, Barr PM, Caron P, Chiu A, Constine LS, Drullinsky P, Friedberg JW, Gerecitano JF, Hamilton A, Hamlin PA, Horwitz SM, Jacob AG, Matasar MJ, McArthur GN, McCall SJ, Moskowitz AJ, Noy A, Palomba ML, Portlock CS, Straus DJ, VanderEls N, Verwys SL, Yang J, Younes A, Zelenetz AD, Zhang Z, Moskowitz CH. Brentuximab vedotin and AVD followed by involved-site radiotherapy in early stage, unfavorable risk Hodgkin lymphoma. Blood. 2016 Sep 15;128(11):1458-64. doi: 10.1182/blood-2016-03-703470. Epub 2016 Jul 25. PMID 27458003