Status:
COMPLETED
Brentuximab Vedotin (SGN-35) in Transplant Eligible Patients With Relapsed or Refractory Hodgkin Lymphoma
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
Seagen Inc.
Hôpitaux Universitaires Henri Mondor, France
Conditions:
Hodgkin's Lymphoma
Eligibility:
All Genders
12-72 years
Phase:
PHASE2
Brief Summary
The purpose of this study is determine if 2 cycles of SGN-35 can be used instead of ICE prior to autologous stem cell transplant (ASCT) for relapsed and refractory HL. There are 2 steps to treating pa...
Eligibility Criteria
Inclusion
- 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
- 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 inappropriate.
- Peripheral neuropathy \> grade 2
Key Trial Info
Start Date :
January 5 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 14 2024
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT01508312
Start Date
January 5 2012
End Date
March 14 2024
Last Update
October 21 2025
Active Locations (1)
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1
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065