Lymphoma
Conditions
Keywords
cHL, Hodgkin lymphoma, Lymphoma, relapsed Lymphoma, SGN-35, Brentuximab Vedotin, Rituxan, Rituximab
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.
Interventions
BIOLOGICALBrentuximab vedotin
Day 1 every three weeks (weeks 0, 3, 6, 9, ... 27): 1.8 mg/kg IV. Ten doses maximum.
BIOLOGICALRituximab
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.
Sponsors
Genentech, Inc.
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Failure-free survival | Up to 7 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Survival | Up to 7 months | Percentage of participants alive with and without disease relapse. |
| Response rate | Up to 7 months | 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 |
| Safety of combination of brentuximab vedotin and rituximab in relapsed classical Hodgkin's Lymphoma | Up to 7 months | Percentage of participants with grade 3-4 adverse events by CTCAE 4.0. |
| Duration of response | Up to 7 months | Median number of weeks that best response was maintained until disease relapse or death. |
| Measurement of circulating clonotypic B cells (CCBCs) | Pre-study, Day 1, Week 12, Week 18, Week 24, Week 30, and time of relapse | Median percentage change in CCBCs between initiation and completion of study. |
| Time to best response | Up to 7 months | Median number of weeks from protocol initiation to best response. |
Countries
United States
Outcome results
None listed