Study of Rituximab and Brentuximab Vedotin for Relapsed Classical Hodgkin Lymphoma

NCT ID: NCT01900496

Last Updated: 2018-10-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2017-07-31

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.

Conditions

Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Brentuximab vedotin & Rituximab

Brentuximab vedotin:

Will be administered at 1.8 mg/kg IV over 30 minutes is given for up to 10 doses (cycles), with a cycle length of 21 days. Brentuximab vedotin is first given on day 1 of cycles 1, 2, 3, and 4 as a single agent (weeks 0, 3, 6, and 9, respectively). Four cycles are chosen because of the 12-week median time to CR in the pivotal phase 2 trial of brentuximab vedotin after autologous BMT for HL.

Brentuximab vedotin will be administered with Rituximab at 375 mg/m2 IV is given for up to 8 "induction" doses: day 1 of week 6, 7, 8, and 9; day 1 of week 12, 15, 18 and 21. This is followed by rituximab "maintenance" (375 mg/m2 IV once every 3 months x 2 doses) to complete a ~ 1 year total course of therapy.

Group Type: EXPERIMENTAL

Brentuximab vedotin

Intervention Type: BIOLOGICAL

Day 1 every three weeks (weeks 0, 3, 6, 9, ... 27): 1.8 mg/kg IV. Ten doses maximum.

Rituximab

Intervention Type: BIOLOGICAL

Day 1 of weeks 12, 13, 14, 15, 18, 21, 24, and 27: 375 mg/m\^2 IV. Additional doses are given at three and six months post week 27.

Interventions

Brentuximab vedotin

Day 1 every three weeks (weeks 0, 3, 6, 9, ... 27): 1.8 mg/kg IV. Ten doses maximum.

Intervention Type: BIOLOGICAL

Rituximab

Day 1 of weeks 12, 13, 14, 15, 18, 21, 24, and 27: 375 mg/m\^2 IV. Additional doses are given at three and six months post week 27.

Intervention Type: BIOLOGICAL

Other Intervention Names

SGN-35; Adcetris; Rituxan

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nina Wagner-Johnston, MD

Role: PRINCIPAL_INVESTIGATOR

The Johns Hopkins University

Locations

The Sidney Kimmel Comprehensive Canceer Center

Baltimore, Maryland, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

NA_00080336

Identifier Type: OTHER

Identifier Source: secondary_id

J1354

Identifier Type: -

Identifier Source: org_study_id