Sgn 35 trial

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Try the modernized ClinicalTrials. Learn more about the modernization effort. Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or results information.

Search for terms. Save this study. Warning You have reached the maximum number of saved studies A Pivotal Open-Label Trial of Brentuximab Vedotin for Hodgkin Lymphoma The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U. Federal Government. Read our disclaimer for details. Results First Posted : October 26, Last Update Posted : March 13, Study Description. This is a single-arm, open-label, multicenter, pivotal clinical trial to evaluate the efficacy and safety of brentuximab vedotin SGN as a single agent in patients with relapsed or refractory Hodgkin lymphoma.

Drug Information available for: Brentuximab vedotin. FDA Resources. Arms and Interventions. Outcome Measures. Repeated measures analysis of variance ANOVA models will be used to evaluate the effect of AVD and brentuximab vedotin on CD4 counts after 1, 4, and 6 courses, and every 3 months after treatment completion for one year.

Repeated measures ANOVA models will be used to evaluate the effect of AVD and brentuximab vedotin on CD8 counts after 1, 4, and 6 courses, and every 3 months after treatment completion for one year. Repeated measures ANOVA models will be used to evaluate the effect of AVD and brentuximab vedotin on viral load after 1, 4, and 6 courses, and every 3 months after treatment completion for one year.

Log-rank analysis will be used to evaluate HAART status at baseline for difference in outcome in terms of overall survival and progression free survival.

Will be tabulated. Eligibility Criteria. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Alternatively, this documentation may include a record that another physician has documented that the participant has HIV infection based on prior ELISA and western blot, or other approved diagnostic tests Histologic diagnosis of CDpositive classical HL as defined by the WHO Classification of Hematological diseases. Also, if the elevated bilirubin is thought to be secondary to cHL the patients should not be excluded from study participation Female subjects must have a negative pregnancy test within 1 week of enrollment and all subjects must agree to use two reliable methods of contraception simultaneously if conception is possible during the study Should a woman subject become pregnant or suspect she is pregnant while the subject is participating in this study, she should inform her treating physician immediately.

The patient will then be removed from protocol therapy Subjects who father a child while participating in the study will be permitted to continue with the protocol.

See Appendix Non-measurable tumor parameters will be defined as not having bi-dimensional measurements i. Use of experimental antiretroviral agents or those containing zidovudine or ritonavir, cobicistat or similar potent CYP3 inhibitors are prohibited, as explained in Section 5.

In order to be eligible, patients taking zidovudine or ritonavir, or cobicistat or other CYP3 inhibitors must change to a different regimen 7 days prior to therapy initiation. National Institutes of Health U. Department of Health and Human Services. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators.

Drug: brentuximab vedotin Drug: rifampin Drug: midazolam Drug: ketoconazole. Phase 1. Study Type :. Interventional Clinical Trial. Actual Enrollment :. Study Start Date :. Actual Primary Completion Date :. Actual Study Completion Date :. Drug: brentuximab vedotin 1. The secondary endpoints are pharmacokinetics, response rate, complete remission rate, response duration, progression-free survival and event-free survival.

The reduction rate of tumor will be calculated according to revised response criteria for malignant lymphoma for measurable tumor.