Study of Rituximab and Brentuximab Vedotin for Relapsed Classical Hodgkin Lymphoma

Lymphoma Clinical Trial

Official title:

Pilot Study of Rituximab and Brentuximab Vedotin With Deferred BMT for Relapsed Classical Hodgkin Lymphoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01900496
• Other study ID #: J1354
• Secondary ID: NA_00080336
• Status: Terminated
• Phase: Phase 1
• Start date: June 2014
• Est. completion date: July 2017

Study information

• Verified date: October 2018
• Source: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This research is being done to study a combination of Brentuximab vedotin and Rituximab for the treatment of relapsed Hodgkin's Lymphoma (HL).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Hodgkin Disease
• Lymphoma

Intervention

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

Locations

Country	Name	City	State
United States	The Sidney Kimmel Comprehensive Canceer Center	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Failure-free survival	Percentage of participants alive without any of the following: death, disease progression or relapse, or failure to achieve complete remission as defined by the Cheson criteria. Per Cheson Criteria: Complete Response (CR) is disappearance of all evidence of disease; Partial Response (PR) is regression of measurable disease and no new sites (=50% decrease in sum of product diameters of up to 6 largest dominant masses and splenic/liver nodules), and no increase in size of other nodes/liver/spleen; reduction in target lesions, no growth of non-target or new lesions; Progression is any new lesion or increase by =50% of previously involved sites from the nadir	Up to 7 months
Secondary	Safety of combination of brentuximab vedotin and rituximab in relapsed classical Hodgkin's Lymphoma	Percentage of participants with grade 3-4 adverse events by CTCAE 4.0.	Up to 7 months
Secondary	Survival	Percentage of participants alive with and without disease relapse.	Up to 7 months
Secondary	Response rate	Percentage of participants with partial and complete remissions as defined by Cheson criteria: Complete Response (CR) is disappearance of all evidence of disease; Partial Response (PR) is regression of measurable disease and no new sites (=50% decrease in sum of product diameters of up to 6 largest dominant masses and splenic/liver nodules), and no increase in size of other nodes/liver/spleen; reduction in target lesions, no growth of non-target or new lesions	Up to 7 months
Secondary	Time to best response	Median number of weeks from protocol initiation to best response.	Up to 7 months
Secondary	Duration of response	Median number of weeks that best response was maintained until disease relapse or death.	Up to 7 months
Secondary	Measurement of circulating clonotypic B cells (CCBCs)	Median percentage change in CCBCs between initiation and completion of study.	Pre-study, Day 1, Week 12, Week 18, Week 24, Week 30, and time of relapse