This research is being done to study a combination of Brentuximab vedotin and Rituximab for the treatment of relapsed Hodgkin's Lymphoma (HL).
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Day 1 every three weeks (weeks 0, 3, 6, 9, ... 27): 1.8 mg/kg IV. Ten doses maximum.
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.
The Sidney Kimmel Comprehensive Canceer Center
Baltimore, Maryland, United States
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
Time frame: Up to 7 months
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.
Time frame: Up to 7 months
Survival
Percentage of participants alive with and without disease relapse.
Time frame: Up to 7 months
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
Time frame: Up to 7 months
Time to best response
Median number of weeks from protocol initiation to best response.
Time frame: Up to 7 months
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Duration of response
Median number of weeks that best response was maintained until disease relapse or death.
Time frame: Up to 7 months
Measurement of circulating clonotypic B cells (CCBCs)
Median percentage change in CCBCs between initiation and completion of study.
Time frame: Pre-study, Day 1, Week 12, Week 18, Week 24, Week 30, and time of relapse