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Allogeneic Stem Cell Transplantation With Adoptive Immunotherapy in Epstein-Barr Virus Positive Recurrent/Refractory Hodgkins Lymphoma

NCT01636388 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2017-12-22

No results posted yet for this study

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.

Conditions

  • Hodgkins Lymphoma

Interventions

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.

Sponsors & Collaborators

  • Children's National Research Institute

    collaborator OTHER

  • Baylor College of Medicine

    collaborator OTHER

  • M.D. Anderson Cancer Center

    collaborator OTHER

  • City of Hope Medical Center

    collaborator OTHER

  • Johns Hopkins University

    collaborator OTHER

  • Ohio State University

    collaborator OTHER

  • University of Utah

    collaborator OTHER

  • University of Michigan

    collaborator OTHER

  • New York Medical College

    lead OTHER

Principal Investigators

  • Mitchell S Cairo, MD · New York Medical College

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2017-06-30
Completion
2017-12-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01636388 on ClinicalTrials.gov