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
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Hodgkins Lymphoma
- Sponsor
- New York Medical College
- Enrollment
- 2
- Locations
- 1
- Primary Endpoint
- Toxicity
- Status
- Terminated
- Last Updated
- 8 years ago
Overview
Brief Summary
The investigators intend to utilize 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. One of three reduced intensity conditioning regimens predetermined at each institutional center of the Childhood, Adolescent and Young Adult Lymphoma Cell Therapy Consortium (LCTC) will be utilized for related or matched unrelated adult donor allogeneic transplant followed by donor LMP specific CTL infusion for three doses post AlloSCT. The investigators hypothesize that the addition of donor derived LMP specific CTLs will be safe and feasible.
Investigators
Mitchell Cairo
Principal Investigator
New York Medical College
Eligibility Criteria
Inclusion Criteria
- •Patient must be 45 years of age or less.
- •Patient or the patient's legally authorized guardian must be fully informed about their illness and the investigational nature of the study protocol (including foreseeable risks and possible side effects), and must sign an informed consent in accordance with the institutional policies approved by the U.S. Department of Health and Human Services.
- •Patients should have been off other investigational therapy for one month prior to entry in this study.
- •Patient must have adequate organ function as below
- •Adequate renal function defined as:
- •Serum creatinine \<2.0 x normal, or Creatinine clearance or radioisotope GFR \> 40 ml/min/m2 or \>60 ml/min/1.73 m2 or an equivalent GFR as determined by the institutional normal range
- •Adequate liver function defined as:
- •Total bilirubin \<2.0 x normal; and SGOT (AST) or SGPT (ALT) \<5.0 x normal
- •Adequate cardiac function defined as:
- •Shortening fraction of \>27% by echocardiogram
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.
- •EBV negative Hodgkin Lymphoma. Patients who don't have an eligible donor (outlined in 7.0) are ineligible. Women who are pregnant are ineligible. Negative pregnancy test in women of childbearing age is required.
Outcomes
Primary Outcomes
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.
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.
Secondary Outcomes
- Feasibility(1 year)