Non-Hodgkin Lymphoma Trial
ECHELON-2, Study ID: SGN35-014
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This trial is currently enrolling patients in the following locations:
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Updated March 5, 2014
A phase 3 randomized, double-blind clinical trial comparing brentuximab vedotin plus CHP (cyclophosphamide, doxorubicin, prednisone) with the standard-of-care CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) in the frontline treatment of patients with CD30-positive mature T-cell lymphomas.
What is a phase 3 study?
A phase 3 study normally involves more patients than a phase 2 trial and confirms the efficacy of the study drug and compares it to commonly used therapies. They also generate long-term safety data for the study drug.
In the SGN35-014 study, you will be given 6 to 8 cycles of treatment with either the chemotherapy CHOP or brentuximab vedotin plus CHP. You and your study doctor will not know which treatment combination you are given. This type of trial, in which the study treatments are not known, is called a “blinded” trial. You will have a 50-50 chance of receiving either CHOP or brentuximab vedotin plus CHP. This selection will be done by a computer.
Who can participate?
- You are 18 or older.
- You have been newly diagnosed with one of the following mature T-cell lymphoma subtypes: systemic anaplastic large cell lymphoma (sALCL), peripheral T-cell lymphoma – not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), adult T-cell leukemia/lymphoma (ATLL; acute and lymphoma types only, must be positive for human T-cell leukemia virus 1), enteropathy-associated T-cell lymphoma (EATL), hepatosplenic T-cell lymphoma.
- At a minimum, you are able to move around and are capable of self-care. You are up and about more than half of waking hours.
- Lab tests meet a minimum requirement.
- Other criteria apply. You will need to see a study doctor to determine if you are able to participate.
Why is the study being done?
This study is being done to test the safety and effectiveness of brentuximab vedotin in combination with CHP (cyclophosphamide, doxorubicin, prednisone) compared with the standard-of-care CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) in patients with mature T-cell lymphomas. At the end of the study, the two groups of patients will be compared to see if there is a difference in the length of response to treatment and whether there are differences in the side effects seen in the two groups.