Brentuximab Vedotin Combined With AVD Chemotherapy in Patients With Newly Diagnosed Early Stage, Unfavorable Risk Hodgkin Lymphoma
NCT ID: NCT01868451
Last Updated: 2025-07-09
Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
NA
118 participants
INTERVENTIONAL
2013-05-31
2026-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort 1 (completed accrual)
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.
Brentuximab vedotin (SGN-35)
Doxorubicin HCL
Vinblastine Sulfate
Dacarbazine
Involved-Site Radiation Therapy (ISRT)
Interim PET
Cohort 2
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.
Brentuximab vedotin (SGN-35)
Doxorubicin HCL
Vinblastine Sulfate
Dacarbazine
Involved-Site Radiation Therapy (ISRT)
Interim PET
Cohort 3
Patients will have early stage, unfavorable risk classical Hodgkin lymphoma with disease bulk 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 and 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 and 15 of each 28 day cycle. This may be followed by 30.6 Gy CVRT.
Brentuximab vedotin (SGN-35)
Doxorubicin HCL
Vinblastine Sulfate
Dacarbazine
Interim PET
consolidation volume RT (CVRT)
Cohort 4
Patients will have early stage, unfavorable risk classical Hodgkin lymphoma with disease bulk defined as the presence of any lymph node mass with transverse maximal diameter \> 7.0 cm or coronal maximal diameter \> 7.0 cm. In this cohort. Pts will receive 4 cycles of brentuximab vedotin \& AVD chemo. Brentuximab vedotin, 1.2 mg/kg, will be administered on days 1 \& 15 of each 28 day cycle. Doxorubicin 25 mg/m2, Vinblastine 6 mg/m2, \& Dacarbazine 375 mg/m2 will be administered on days 1 \& 15 of each 28 day cycle. Pts whose PET scan is negative after 4 cycles of brentuximab vedotin \& AVD chemotherapy will not receive RT. Pts whose PET scan is positive after 4 cycles of brentuximab vedotin \& AVD chemo, but subsequent biopsy is neg, will also receive no RT. Upon MSK PI approval, if the simulation can't be covered by the institution or the pts insurance, a diagnostic IV contrast CT neck \& diagnostic IV contrast CT CAP scan will be done in addition to the FDG-PET done after 4 cycles of chemo.
Brentuximab vedotin (SGN-35)
Doxorubicin HCL
Vinblastine Sulfate
Dacarbazine
Interim PET
Interventions
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Brentuximab vedotin (SGN-35)
Doxorubicin HCL
Vinblastine Sulfate
Dacarbazine
Involved-Site Radiation Therapy (ISRT)
Interim PET
consolidation volume RT (CVRT)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Seagen Inc.
INDUSTRY
University of Rochester
OTHER
City of Hope Medical Center
OTHER
Stanford University
OTHER
Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Anita Kumar, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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City of Hope
Duarte, California, United States
Stanford University Medical Center
Stanford, California, United States
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen
Montvale, New Jersey, United States
Memorial Sloan Kettering Commack
Commack, New York, United States
Memorial Sloan Kettering Westchester
Harrison, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
Memorial Sloan Kettering Nassau
Uniondale, New York, United States
Countries
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References
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Goldkuhle 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.
Kumar 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.
Kumar 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.
Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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13-034
Identifier Type: -
Identifier Source: org_study_id
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