Allogeneic Stem Cell Transplantation With Adoptive Immunotherapy in Epstein-Barr Virus Positive Recurrent/Refractory Hodgkins Lymphoma
|ClinicalTrials.gov Identifier: NCT01636388|
Recruitment Status : Terminated (funding ended)
First Posted : July 10, 2012
Last Update Posted : December 22, 2017
|Condition or disease||Intervention/treatment||Phase|
|Hodgkins Lymphoma||Biological: allogeneic donor derived LMP specific cytotoxic T-lymphocyte||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter Pilot Study of Reduced Intensity Allogeneic Stem Cell Transplantation Followed by Adoptive Cellular Immunotherapy With Donor Derived Latent Membrane Protein (LMP) Specific-CTLs in Patients With Epstein-Barr Virus (EBV)Positive Refractory or Recurrent Hodgkin Lymphoma|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||June 2017|
|Actual Study Completion Date :||December 2017|
Experimental: Allogeneic Stem Cell Transplantation
Reduced intensity conditioning and allogeneic stem cell transplant from EBV positive HLA matched sibling or unrelated adult donor combined with post AlloSCT allogeneic donor derived LMP specific cytotoxic T-lymphocyte (CTL) infusions in EBV positive patients with poor risk Hodgkin Lymphoma.
Biological: allogeneic donor derived LMP specific cytotoxic T-lymphocyte
LMP CTLs will be give at 3 timepoints post allogeneic stem cell transplantation around days 60 to 100, then 30 days apart for the next 2 infusions.
- Safety [ Time Frame: 1 year ]The number of serious adverse events associated with administering allogeneic HLA matched donor derived LMP specific-CTLs in CAYA with EBV-associated refractory/relapsed HL following reduced intensity conditioning (RIC) and allogeneic HSCT will be monitored to determine the safety of this treatment.
- Toxicity [ Time Frame: 1 year ]The number of adverse events associated with administering allogeneic HLA matched donor derived LMP specific-CTLs in CAYA with EBV-associated refractory/relapsed HL following reduced intensity conditioning (RIC) and allogeneic HSCT will be monitored to determine the toxicity of this treatment.
- Feasibility [ Time Frame: 1 year ]Good Manufacturing Practice (GMP) production and shipping of HLA matched donor derived LMP specific-CTLs to multiple sites in various geographic regions of the US following RIC and allogeneic HSCT will be monitored to assess the feasibility.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01636388
|United States, New York|
|New York Medical College|
|Valhalla, New York, United States, 10595|
|Principal Investigator:||Mitchell S Cairo, MD||New York Medical College|