A Phase 3 Study of Brentuximab Vedotin (SGN-35) in Patients at High Risk of Residual Hodgkin Lymphoma Following Stem Cell Transplant (The AETHERA Trial)
Trial ID or NCT#
NCT01100502
Status
NOT RECRUITING
Purpose
This is a randomized, double-blind, placebo-controlled, multicenter phase 3 trial to evaluate the efficacy and safety of brentuximab vedotin (SGN-35) and best supportive care (BSC) compared to placebo and BSC in treatment of residual Hodgkin lymphoma (HL) following autologous stem cell transplant (ASCT).
Official Title
A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of SGN-35 and Best Supportive Care (BSC) Versus Placebo and BSC in the Treatment of Patients at High Risk of Residual Hodgkin Lymphoma Following Autologous Stem Cell Transplant
Eligibility Criteria
Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes
Inclusion Criteria:
- * Patients with HL who have received ASCT in the previous 30-45 days* Patients at high risk of residual HL post ASCT* Histologically-confirmed HL* ECOG of 0 or 1* Adequate organ function
Exclusion Criteria:
- * Previous treatment with brentuximab vedotin* Previously received an allogeneic transplant* Patients who were determined to have a best clinical response of progressive disease with salvage treatment immediately prior to ASCT* History of another primary malignancy that has not been in remission for at least 3 years* Post ASCT or current therapy with other systemic anti-neoplastic or investigational agents
Investigator(s)
Sally Arai
Blood and marrow transplant specialist,
Hematologist,
Blood and marrow transplant specialist
Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Robert Lowsky
Blood and marrow transplant specialist,
Hematologist,
Blood and marrow transplant specialist
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Robert Negrin
Blood and marrow transplant specialist,
Hematologist,
Blood and marrow transplant specialist
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Laura Johnston
Blood and marrow transplant specialist,
Blood and marrow transplant specialist,
Medical oncologist,
Hematologist
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy), Emerita
Judith Shizuru
Blood and marrow transplant specialist,
Hematologist,
Blood and marrow transplant specialist,
Hematologist-Oncologist
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Wen-Kai Weng, MD, PhD
Blood and marrow transplant specialist,
Blood and marrow transplant specialist,
Lymphoma specialist,
Medical oncologist,
Multiple myeloma specialist
Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy) and, by courtesy, of Dermatology
Contact us to find out if this trial is right for you.
Contact
Physician Referrals
650-723-0822
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