Clinical trial NCT01900496: Study of Rituximab and Brentuximab Vedotin for Relapsed Classical Hodgkin Lymphoma
Official title: Pilot Study of Rituximab and Brentuximab Vedotin With Deferred BMT for Relapsed Classical Hodgkin Lymphoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Lymphoma
Keywords: cHL
Hodgkin lymphoma
Lymphoma
relapsed Lymphoma
SGN-35
Brentuximab Vedotin
Rituxan
Rituximab
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2013-07-16
Enrollment: 6
Sex: ALL
Minimum age (years): 16
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 marrow transplant (BMT, also called a stem cell transplant).The study is for people with HL who have never received treatment for relapsed lymphoma, except for radiation therapy. Usually, when HL relapses for the first time, the standard is to receive combinations of chemotherapy, including an autologous blood or marrow transplant (BMT, also called a stem cell transplant) which has about a 40% cure rate. BMT may cure the HL, but also may be associated with serious side effects and risks. This research looks at a combination of drugs for relapsed HL that may not have the side effects of standard therapies and that does not involve BMT. The goal is to treat the lymphoma effectively with drugs that we expect will have fewer side effects, while avoiding a treatment like BMT.

Eligibility 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

Primary outcomes:
measure: Failure-free survival
timeFrame: Up to 7 months
Secondary outcomes:
measure: Safety of combination of brentuximab vedotin and rituximab in relapsed classical Hodgkin's Lymphoma
timeFrame: Up to 7 months
measure: Survival
timeFrame: Up to 7 months
measure: Response rate
timeFrame: Up to 7 months
measure: Time to best response
timeFrame: Up to 7 months
measure: Duration of response
timeFrame: Up to 7 months
measure: Measurement of circulating clonotypic B cells (CCBCs)
timeFrame: Pre-study, Day 1, Week 12, Week 18, Week 24, Week 30, and time of relapse
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: The Sidney Kimmel Comprehensive Canceer Center
state: Maryland
Study officials:
affiliation: The Johns Hopkins University
name: Nina Wagner-Johnston, MD
role: PRINCIPAL_INVESTIGATOR
References: