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.
- 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
- 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.
Roswell Park Cancer Institute
Duke University Medical Center
Contact: Paul Langlie Martin
Medical University of South Carolina
Contact: Michelle Phillips Hudspeth
Trial Phase Phase I/II
Trial Type Treatment
New York Medical College
- Primary ID NYMC 564
- Secondary IDs NCI-2015-01809
- Clinicaltrials.gov ID NCT02098512