Status:
TERMINATED
Study of Rituximab and Brentuximab Vedotin for Relapsed Classical Hodgkin Lymphoma
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Lymphoma
Eligibility:
All Genders
16-100 years
Phase:
PHASE1
Brief Summary
This research is being done to study a combination of Brentuximab vedotin and Rituximab for the treatment of relapsed Hodgkin's Lymphoma (HL).
Detailed Description
This research is being done to study a combination of drugs for relapsed Hodgkin's Lymphoma (HL) that may be easier to tolerate than standard therapies and that does not involve an autologous blood or...
Eligibility Criteria
Inclusion
- Age \> 16 years
- Biopsy-proven diagnosis of classical Hodgkin Lymphoma (regardless of HRS cell CD20 expression) per the World Health Organization classification criteria24; lymphocyte predominant histology is excluded
- Untreated relapse of classical Hodgkin Lymphoma (with the exception of steroids) as follows:HL that relapsed \> 3 months after completion of first-line chemotherapy or combined modality therapy, and has not yet been treated with salvage chemotherapy, Stage I-II HL that relapsed \> 3 months after first-line chemotherapy, then relapsed after radiation therapy delivered with curative intent, and has not yet been treated with salvage chemotherapy
- Radiographically measurable disease (\> 1 focus of lymphoma measuring \> 1.5 cm)
- Baseline laboratories: ANC \> 1000/uL and platelets \> 75,000/uL, unless due to bone marrow involvement by lymphoma, Serum creatinine \< 2.0 mg/dL, Total bilirubin \< 2.0 mg/dL (excluding Gilbert's syndrome), unless due to lymphoma
- ECOG performance status 0, 1 or 2.
Exclusion
- Active concurrent malignancy with the exception of superficial non-melanoma skin cancer and cervical carcinoma in situ.
- Primary induction failure, defined as failure to achieve CR with first-line chemotherapy or chemoradiation, disease progression during first-line chemotherapy or chemoradiation, or progression or biopsy-proven disease persistence within 8 weeks of first-line therapy completion
- Prior brentuximab vedotin or rituximab for lymphoma
- Grade \> 2 peripheral neuropathy
- HIV infection, active hepatitis B infection, or active hepatitis C infection
Key Trial Info
Start Date :
June 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2017
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01900496
Start Date
June 1 2014
End Date
July 1 2017
Last Update
October 17 2018
Active Locations (1)
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1
The Sidney Kimmel Comprehensive Canceer Center
Baltimore, Maryland, United States, 21287