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Completed

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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Key information

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

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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

brentuximab vedotin (SGN-35)

Drug

Doxorubicin HCL

Drug

vinblastine sulfate

Drug

Dacarbazine

Drug

Involved-Site Radiation Therapy (ISRT)

Radiation

Interim PET

Procedure

consolidation volume RT (CVRT)

Radiation

Primary outcomes

  1. 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).

  2. 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

  1. 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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