Lymphoma, Non-Hodgkin Clinical Trial
Official title:
Treatment With SGN-35 in Patients With CD30-positive Hematologic Malignancies Who Have Previously Participated in an SGN-35 Study
This is a multicenter, open-label study to evaluate the safety and efficacy of treatment with brentuximab vedotin (SGN-35) in patients who have previously participated in an brentuximab vedotin study.
This is a multicenter, open-label study to evaluate single-agent brentuximab vedotin
(SGN-35) treatment in patients who previously participated in a brentuximab vedotin study,
including Studies SGN35-005 (NCT01100502), SGN35-007 (NCT01026233), and SGN35-008
(NCT01026415). Patients treated on this study (SGN35-006) could re-enroll on study if
eligible. The study consisted of 2 arms, as follows:
- Retreatment arm: Patients with CD30-positive hematologic malignancies who experienced a
complete remission (CR) or partial remission (PR) with previous brentuximab vedotin
treatment on a clinical study and subsequently experienced disease progression or
relapse. The purpose of this arm was to assess safety and efficacy of retreatment with
brentuximab vedotin.
- Extension treatment arm: Patients with either CD30-positive hematologic or
nonhematologic malignancies who completed treatment in a prior brentuximab vedotin
study without unacceptable toxicity and experienced clinical benefit as assessed by the
investigator. The purpose of this arm was to enable patients who participated in
certain prior brentuximab vedotin trials to receive extension treatment and to assess
patient safety and survival in the extension treatment setting.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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