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Immunotherapy Following Reduced Intensity Conditioning and Allogeneic Stem Cell Transplant for Poor Risk CD30+ Hodgkin Lymphoma Patients

Trial Status: Active

Patients with relapsed or refractory Hodgkin Lymphoma who are CD30+ will receive a standard of care reduced intensity regimen and an allogeneic stem cell transplant (from another person, related or unrelated). Following recovery, patients will receive a medication called Brentuximab Vendotin which is targeted against CD30+ cells. The study hypothesis is that this treatment will be safe and well tolerated in children and young adults.

Inclusion Criteria

  • 45 years of age or less.
  • Patients with Hodgkin Lymphoma with either of the following: • Primary induction failure (failure to achieve initial CR) and/or primary refractory disease OR First, Second or Third relapse AND History of prior ablative auto HSCT or ineligible for an ablative auto HSCT or ≥25% residual disease after at least two reinduction chemotherapy cycles AND HLA matched family donor (6/6 or 5/6) or matched unrelated adult donor (MUD) (8/8) or matched umbilical cord blood unit (≥5/6) with prethaw cell dose of at least 3 x 107/kg TNC.
  • off other investigational therapy for one month prior to entry in this study.
  • adequate organ function

Exclusion Criteria

  • Patients with HD with 4th or greater CR, PR, and/or SD are ineligible.
  • Patients with rapidly progressive disease (PD) unresponsive to reinduction chemo, radio, or immunotherapy are ineligible.
  • Patients who don't have an eligible donor are ineligible.
  • Women who are pregnant are ineligible.

New York

Buffalo
Roswell Park Cancer Institute
Status: WITHDRAWN

North Carolina

Durham
Duke University Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Paul Langlie Martin
Phone: 888-275-3853

South Carolina

Charleston
Medical University of South Carolina
Status: COMPLETED
Contact: Michelle Phillips Hudspeth
Phone: 843-792-9321

Trial Phase Phase I/II

Trial Type Treatment

Lead Organization
New York Medical College

  • Primary ID NYMC 564
  • Secondary IDs NCI-2015-01809
  • Clinicaltrials.gov ID NCT02098512