Overview

Study of Rituximab and Brentuximab Vedotin for Relapsed Classical Hodgkin Lymphoma

Status:
Recruiting
Trial end date:
0000-00-00
Target enrollment:
25
Participant gender:
Both
Summary
This research is being done to study a combination of Brentuximab vedotin and Rituximab for the treatment of relapsed Hodgkin's Lymphoma (HL).
Phase:
Phase 0
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center
Treatments:
Antibodies, Monoclonal
Rituximab
Last Updated:
2016-05-17
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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