Immunotherapy Following Reduced Intensity Conditioning and Allogeneic Stem Cell Transplant for Poor Risk CD30+ Hodgkin Lymphoma Patients
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|ClinicalTrials.gov Identifier: NCT02098512|
Recruitment Status : Recruiting
First Posted : March 28, 2014
Last Update Posted : March 29, 2018
|Condition or disease||Intervention/treatment||Phase|
|Hodgkin Lymphoma||Drug: Brentuximab Vedotin Procedure: Allogeneic Stem Cell Transplantation Drug: Reduced Intensity Conditioning||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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)|
|Study Start Date :||March 2014|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2019|
Experimental: Allogeneic Transplant and Immunotherapy
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
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:
Other Name: Adcetris
Procedure: Allogeneic Stem Cell Transplantation
Following conditioning with chemotherapy, patients will receive stem cells from a matched related or unrelated donor.
Drug: Reduced Intensity Conditioning
Patients will receive reduced intensity chemotherapy with one of three regimens: Busulfan/Fludarabine; Gemcitabine/Fludarabine/Melphalan; Fludarabine/Cyclophosphamide
- Safety [ Time Frame: 1 year ]Patients will be followed for one year for adverse events related to the administration of study drug.
- Overall Survival [ Time Frame: 1 year ]patients will be assessed for one year to determine survival status
- To assess feasibility of developing a bank of LMP-specific CTLs from healthy donors [ Time Frame: 3 years ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02098512
|Contact: Mitchell Cairo, MDfirstname.lastname@example.org|
|Contact: Jessica Hochberg, MDemail@example.com|
|United States, New York|
|New York Medical College||Recruiting|
|Valhalla, New York, United States, 10595|
|Contact: Mitchell Cairo 914-594-2150 firstname.lastname@example.org|
|Contact: Jessica Hochberg, MD 914-594-2132 email@example.com|
|Principal Investigator:||Mitchell Cairo, MD||New York Medical College|