A Phase 1/2 interventional study of Brentuximab Vedotin and Allogeneic Stem Cell Transplantation in Hodgkin Lymphoma, sponsored by New York Medical College. Status unknown at 1 site in United States. Open to participants aged Up to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-10-27.
Sponsored by New York Medical College · Phase 1/2, Interventional, and Treatment
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.
5,579 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's planned enrollment of 20 is below the median of 40 across 4,509 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →New York Medical College is the lead sponsor of 69 studies on the registry; 23 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with Hodgkin Lymphoma with either of the following:
Exclusion Criteria:
We intend to utilize reduced intensity conditioning and allogeneic stem cell transplant from HLA matched sibling or unrelated adult donor followed by post-AlloSCT Brentuximab Vedotin in patients with poor risk Hodgkin Lymphoma.
Drug: Brentuximab Vedotin · Procedure: Allogeneic Stem Cell Transplantation · Drug: Reduced Intensity Conditioning
Brentuximab Vedotin will be administered every 21 days starting on or around Day +42 post allogeneic stem cell transplant for a TOTAL of 4 doses as outlined below: * 42 (+/-7 days) Brentuximab Vedotin 1.8 mg/kg (max=180 mg) IV x 1 * 63 (+/- 7 days) Brentuximab Vedotin 1.8 mg/kg (max=180 mg) IV x 1 * 84 (+/- 7 days) Brentuximab Vedotin 1.8 mg/kg (max = 180 mg) IV x 1 * 105 (+/- 7 days) Brentuximab Vedotin 1.8 mg/kg (max=180 mg) IV x 1
Also known as: Adcetris
Following conditioning with chemotherapy, patients will receive stem cells from a matched related or unrelated donor.
Patients will receive reduced intensity chemotherapy with one of three regimens: Busulfan/Fludarabine; Gemcitabine/Fludarabine/Melphalan; Fludarabine/Cyclophosphamide
Safety
Patients will be followed for one year for adverse events related to the administration of study drug.
Time frame: 1 year
Overall Survival
patients will be assessed for one year to determine survival status
Time frame: 1 year
To assess feasibility of developing a bank of LMP-specific CTLs from healthy donors
A bank of from identified EBV positive donors will be established for potential use in current and future clinical trials in LMP-positive lymphomas. Annual review will occur to assess the feasibility of recruiting healthy donors to help build this cell line bank. If there are no cell lines developed within the first year, an alternative design may be considered.
Time frame: 3 years
This study is status unknown, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
New York Medical College