Brief Summary
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.
Brief Title
Immunotherapy Following Reduced Intensity Conditioning and Allogeneic Stem Cell Transplant for Poor Risk CD30+ Hodgkin Lymphoma Patients
Categories
Completion Date
Completion Date Type
Estimated
Conditions
Hodgkin Lymphoma
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.
* 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.
Inclusion 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
* 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
Gender
All
Gender Based
false
Keywords
Brentuximab Vedotin
Immunotherapy
Relapsed Hodgkin Lymphoma
Refractory Hodgkin Lymphoma
Reduced Intensity Conditioning
Allogeneic Stem Cell Transplantation
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
45 Years
NCT Id
NCT02098512
Org Class
Other
Org Full Name
New York Medical College
Org Study Id
NYMC 564
Overall Status
Unknown status
Phases
Phase 1
Phase 2
Primary Completion Date
Primary Completion Date Type
Actual
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)
Primary Outcomes
Outcome Description
Patients will be followed for one year for adverse events related to the administration of study drug.
Outcome Measure
Safety
Outcome Time Frame
1 year
Outcome Description
patients will be assessed for one year to determine survival status
Outcome Measure
Overall Survival
Outcome Time Frame
1 year
Secondary Outcomes
Outcome 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.
Outcome Time Frame
3 years
Outcome Measure
To assess feasibility of developing a bank of LMP-specific CTLs from healthy donors
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Child
Adult
Maximum Age Number (converted to Years and rounded down)
45
Minimum Age Number (converted to Years and rounded down)
0
Investigators
Investigator Type
Principal Investigator
Investigator Name
Kris Mahadeo
Investigator Email
kmahadeo@montefiore.org
Investigator Phone
718-741-2342