Description:
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.
Title
- Brief Title: Immunotherapy Following Reduced Intensity Conditioning and Allogeneic Stem Cell Transplant for Poor Risk CD30+ Hodgkin Lymphoma Patients
- Official Title: A Multicenter Pilot Study of Reduced Intensity Conditioning and Allogeneic Stem Cell Transplantation Followed by Targeted Immunotherapy in Children, Adolescents and Young Adults With Poor Risk CD30+ Hodgkin Lymphoma (HL)
Clinical Trial IDs
- ORG STUDY ID:
NYMC 564
- NCT ID:
NCT02098512
Conditions
Interventions
Drug | Synonyms | Arms |
---|
Brentuximab Vedotin | Adcetris | Allogeneic Transplant and Immunotherapy |
Reduced Intensity Conditioning | | Allogeneic Transplant and Immunotherapy |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Allogeneic Transplant and Immunotherapy | Experimental | 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. | - Brentuximab Vedotin
- Reduced Intensity Conditioning
|
Eligibility Criteria
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.
Maximum Eligible Age: | 45 Years |
Minimum Eligible Age: | N/A |
Eligible Gender: | All |
Healthy Volunteers: | Accepts Healthy Volunteers |
Primary Outcome Measures
Measure: | Safety |
Time Frame: | 1 year |
Safety Issue: | |
Description: | Patients will be followed for one year for adverse events related to the administration of study drug. |
Secondary Outcome Measures
Measure: | To assess feasibility of developing a bank of LMP-specific CTLs from healthy donors |
Time Frame: | 3 years |
Safety Issue: | |
Description: | 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. |
Details
Phase: | Phase 1/Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Unknown status |
Lead Sponsor: | New York Medical College |
Trial Keywords
- Brentuximab Vedotin
- Immunotherapy
- Relapsed Hodgkin Lymphoma
- Refractory Hodgkin Lymphoma
- Reduced Intensity Conditioning
- Allogeneic Stem Cell Transplantation
Last Updated
March 13, 2019