NCT Number: NCT01868451
Brentuximab Vedotin Combined With AVD Chemotherapy in Patients With Newly Diagnosed Early Stage, Unfavorable Risk Hodgkin Lymphoma
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.
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
City of Hope, Duarte, California, United States
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Doxorubicin HCL
Drugvinblastine sulfate
DrugDacarbazine
DrugInvolved-Site Radiation Therapy (ISRT)
RadiationInterim PET
Procedureconsolidation volume RT (CVRT)
RadiationPrimary outcomes
-
development of significant pulmonary toxicity
Time frame: 1 year
specifically non-infectious pneumonitis The definition of unacceptable pulmonary toxicity will be defined as the development of grade 2 or higher pneumonitis as defined by Common Terminology Criteria for Adverse Events (CTCAE version 4).
-
complete responses (all cohorts)
Time frame: 1 year
Evaluate the rate of PET-negative complete responses after completion of the treatment program (8 weeks (+/- 2 weeks) after completion of radiotherapy).
Secondary outcomes
-
Evaluate the prognostic significance
Time frame: 1 year
(i.e. correlation with progression free survival) of interim fluorodeoxyglucose-positron emission tomography (PET) in this patient population measured by visual analysis and semi-quantitative analysis.
Sponsors and collaborators
Lead sponsor
Memorial Sloan Kettering Cancer Center
Other
Collaborators
- City of Hope Medical Center
- Seagen Inc.
- Stanford University
- University of Rochester
Registry information
Official study title
A Pilot Study of Brentuximab Vedotin Combined With AVD Chemotherapy in Patients With Newly Diagnosed Early Stage, Unfavorable Risk Hodgkin Lymphoma
Important dates
- Study start
- 2013
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Jun 4, 2013
- Registry last updated
- Jun 4, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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