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Brentuximab Vedotin (SGN-35) in Transplant Eligible Patients With Relapsed or Refractory Hodgkin Lymphoma

Phase 2
12 Years
72 Years
Open (Enrolling)
Hodgkin's Lymphoma

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Trial Information

Brentuximab Vedotin (SGN-35) in Transplant Eligible Patients With Relapsed or Refractory Hodgkin Lymphoma

Inclusion Criteria:

- Histologic diagnosis of cd30 positive classical Hodgkin's lymphoma.

- Primary refractory or relapsed disease proven by biopsy or fine needle aspiration
(cytology) of an involved site. Pathology must be reviewed at MSKCC.

- Relapse or refractory disease following doxorubicin or nitrogen mustard containing
front-line therapy

- Fluorodeoxyglucose (FDG)-avid disease by FDG-PET/CT and measurable disease of at
least 1.5 cm by spiral CT, as assessed by the site radiologist.

- Cardiac ejection fraction of greater than 45%, measured since last chemotherapy.

- Hemoglobin-adjusted diffusing capacity for carbon monoxide of greater than 50% on
pulmonary function testing, measured since last chemotherapy

- Serum creatinine < or = to 1.5 mg/dl; if creatinine >1.5 mg/dl then the measured 12-
or 24-hour creatinine clearance must be >60 ml/minute.

- ANC>1000/μl and Platelets>50,000/μl

- Total bilirubin < 2.0 mg/dl in the absence of a history of Gilbert's disease.

- Females of childbearing age must be on an acceptable form of birth control.

- Age between 12 and 72

- HIV I and II negative.

Exclusion Criteria:

- Received more than 1 prior treatment (combined modality therapy represents 1
treatment) for Hodgkin Lymphoma

- Hepatitis B surface antigen positive or hepatitis B core antibody positive.

- Known pregnancy or breast-feeding.

- Medical illness unrelated to Hodgkin's Lymphoma, which, in the opinion of the
attending physician and/or principal investigator, makes participation in this study

- Peripheral neuropathy > grade 2

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

rate of FDG-PET/CT normalization

Outcome Description:

Following salvage therapy with brentuximab vedotin (SGN-35) alone or followed by augmented ICE chemotherapy.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Allison Moskowitz, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

January 2012

Completion Date:

January 2014

Related Keywords:

  • Hodgkin's Lymphoma
  • 11-142
  • Hodgkin Disease
  • Lymphoma



Memorial Sloan Kettering Cancer Center New York, New York  10021