Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| St. Baldrick's Foundation | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brentuximab Vedotin | Drug | 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:
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety | Patients will be followed for one year for adverse events related to the administration of study drug. | 1 year |
| Overall Survival | patients will be assessed for one year to determine survival status | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mitchell Cairo, MD | New York Medical College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York Medical College | Valhalla | New York | 10595 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Allogeneic Stem Cell Transplantation | Procedure | Following conditioning with chemotherapy, patients will receive stem cells from a matched related or unrelated donor. |
|
| Reduced Intensity Conditioning | Drug | Patients will receive reduced intensity chemotherapy with one of three regimens: Busulfan/Fludarabine; Gemcitabine/Fludarabine/Melphalan; Fludarabine/Cyclophosphamide |
|
| 3 years |
| ID | Term |
|---|---|
| D006689 | Hodgkin Disease |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000079963 | Brentuximab Vedotin |
| ID | Term |
|---|---|
| D009842 | Oligopeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided