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Status:

ACTIVE_NOT_RECRUITING

Autologous/Allogeneic TGFbeta-resistant LMP-specific CTL, Lymphoma (TGF-beta)

Lead Sponsor:

Baylor College of Medicine

Collaborating Sponsors:

The Methodist Hospital Research Institute

Center for Cell and Gene Therapy, Baylor College of Medicine

Conditions:

Lymphoma

Hodgkin's Disease

Eligibility:

All Genders

Phase:

PHASE1

Brief Summary

Patients have a type of lymph gland cancer called HD, NHL or lymphoepithelioma (these 3 diseases will be referred to as "Lymphoma"). The lymphoma has come back or has not gone away after treatment. Th...

Detailed Description

Investigators will test a biopsy of the tumor to see if the tumor cells are EBV positive and to see if the subject is eligible for this study. Then they will take some blood from the donor, which is u...

Eligibility Criteria

Inclusion

  • INCLUSION CRITERIA:
  • Any patient, regardless of age or sex, with EBV-positive lymphoma, or lymphoepithelioma regardless of the histological subtype or EBV (associated)-T/NK-LPD all confirmed on any tissue sample.
  • Primary refractory lymphoma or in second or subsequent relapse including after autologous or syngeneic stem cell transplant OR patients at a high risk for relapse defined as: (i) patients with primary refractory lymphoma or multiply relapsed lymphoma who are in remission but not eligible for autologous SCT or (ii) patients with relapsed lymphoma after autologous SCT who are in remission but not eligible for allogeneic SCT (Group A)
  • OR
  • Any patient who has received an allogeneic SCT for EBV Lymphoma or EBV (associated)-T/NK-LPD or Lymphoepithelioma (Group B)
  • Patients with life expectancy 6 weeks or greater from the time of CTL infusion.
  • Patients with a Karnofsky score of 50 or greater.
  • If post allogeneic SCT must not have less than 50% donor chimerism in either peripheral blood or bone marrow
  • Patients with bilirubin 3x normal or less, AST 5x normal or less, and Hgb greater than 8.0
  • Patients with a creatinine 2x normal for age or less
  • Patients with O2 saturations greater than 93% on room air (measured by pulse oximetry)
  • Patient, parent/guardian able to give informed consent.
  • Patients should have been off other investigational therapy for one month prior to entry in this study.
  • EXCLUSION CRITERIA:
  • Patients with a severe intercurrent infection.
  • Patients with evidence of GVHD greater than Grade II at time of enrollment.
  • HIV positive at time of procurement cells for CTL generation
  • Due to unknown effects of this therapy on a fetus, pregnant women are excluded from this research. The male partner should use a condom.

Exclusion

    Key Trial Info

    Start Date :

    April 1 2006

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    July 1 2031

    Estimated Enrollment :

    8 Patients enrolled

    Trial Details

    Trial ID

    NCT00368082

    Start Date

    April 1 2006

    End Date

    July 1 2031

    Last Update

    October 31 2025

    Active Locations (2)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (2 locations)

    1

    Houston Methodist Hospital

    Houston, Texas, United States, 77030

    2

    Texas Childrens Hospital

    Houston, Texas, United States, 77030