Brentuximab Vedotin Combined With AVD Chemotherapy in Patients With Newly Diagnosed Early Stage, Unfavorable Risk Hodgkin Lymphoma

Not Recruiting

Trial ID: NCT01868451

Purpose

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.

Official Title

A Pilot Study of Brentuximab Vedotin Combined With AVD Chemotherapy in Patients With Newly Diagnosed Early Stage, Unfavorable Risk Hodgkin Lymphoma

Stanford Investigator(s)

Neel K. Gupta
Neel K. Gupta

Clinical Associate Professor, Medicine - Oncology Clinical Assistant Professor, Medicine - Hematology

Ranjana Advani
Ranjana Advani

Saul A. Rosenberg, MD, Professor of Lymphoma

Lauren Maeda
Lauren Maeda

Clinical Associate Professor, Medicine - Oncology

Eligibility

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.

Intervention(s):

drug: Brentuximab vedotin (SGN-35)

drug: Doxorubicin HCL

drug: Vinblastine Sulfate

radiation: Involved-Site Radiation Therapy (ISRT)

procedure: Interim PET

drug: Dacarbazine

radiation: consolidation volume RT (CVRT)

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Sipra Choudhury
650-736-2563

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