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

Trial ID or NCT#

NCT01868451

Status

not recruiting iconNOT RECRUITING

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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.

Investigator(s)

Neel K. Gupta
Neel K. Gupta
Hematologist-Oncologist
Clinical Assistant Professor, Medicine - Oncology Clinical Assistant Professor, Medicine - Hematology
Ranjana Advani
Ranjana Advani
Lymphoma specialist, Hematologist-Oncologist
Saul A. Rosenberg, MD, Professor of Lymphoma
Lauren Maeda
Lauren Maeda
Hematologist, Lymphoma specialist, Hematologist-Oncologist
Clinical Associate Professor, Medicine - Oncology

Contact us to find out if this trial is right for you.

Contact

Sipra Choudhury
650-736-2563