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COMPLETED Phase 1

LMP-specific T-cells for Patients With Relapsed EBV-positive Lymphoma

NCT00062868 · View on ClinicalTrials.gov ↗

Study Summary

This protocol is broken up into 2 portions to determine the maximum tolerated dose for treating patients with a type of lymph gland disease. The 1st portion, called ALASCER are for people with a type of lymph gland cancer called Hodgkin or non-Hodgkin Lymphoma or Lymphoepithelioma which has returned or may return or has not gone away after treatment, including the best treatment we know for Lymphoma. While the 2nd portion (ALCI) also includes Lymphoepithelioma, severe chronic active EBV (SCAEBC), and leiomyosarcoma. Some patients with Lymphoma show evidence of infection with the virus that causes infectious mononucleosis Epstein Barr virus (EBV) before or at the time of their diagnosis. EBV is found in the cancer cells of up to half the patients with Hodgkin's and non-Hodgkin Lymphoma, suggesting that it may play a role in causing Lymphoma. The cancer cells (in lymphoma) and some B cells (in SCAEBV) infected by EBV are able to hide from the body's immune system and escape destruction. Investigators want to see if special white blood cells, called T cells, that have been trained to kill EBV infected cells can survive in your blood and affect the tumor. The investigators have used this sort of therapy to treat a different type of cancer that occurs after bone marrow or solid organ transplant called post transplant lymphoma. In this type of cancer the tumor cells have 9 proteins made by EBV on their surface. The investigators grew T cells in the laboratory that recognized all 9 proteins and were able to successfully prevent and treat post transplant lymphoma. However in Hodgkin disease and non-Hodgkin Lymphoma and SCAEBV, the tumor cells and B cells only express 2 EBV proteins. In a previous study we made T cells that recognized all 9 proteins and gave them to patients with Hodgkin disease. Some patients had a partial response to this therapy but no patients had a complete response. Investigators think one reason may be that many of the T cells reacted with proteins

Interventions

  • BIOLOGICAL LMP1/2 CTLs (ALCI - Group A)
  • BIOLOGICAL LMP1/2 CTLs (ALCI - Group B)
  • BIOLOGICAL LMP1/2 CTLs (ALCI - Group C)
  • BIOLOGICAL LMP2 CTLs (ALSCER - Group A)
  • BIOLOGICAL LMP2 CTLs (ALSCER - Group B)

Study Locations (2)

Texas

  • Texas Children's Hospital — Houston
  • The Methodist Hospital — Houston

Trial Details

FieldValue
Enrollment Target 74 participants
Start Date 2003-09
Est. Completion 2020-04
Phase Phase 1

Sponsor

Baylor College of Medicine

678 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00062868

The ClinicalTrials.gov registry entry for NCT00062868 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 74 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baylor College of Medicine, which has 678 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 4 conditions, with Non Hodgkin Lymphoma appearing as the primary indexed condition, and to 5 interventions — of which LMP1/2 CTLs (ALCI - Group A) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00062868 reports 2 study locations spanning 1 distinct geographic area — top geographies include Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00062868 about?

NCT00062868 is a clinical study titled "LMP-specific T-cells for Patients With Relapsed EBV-positive Lymphoma". This protocol is broken up into 2 portions to determine the maximum tolerated dose for treating patients with a type of lymph gland disease. The 1st portion, called ALASCER are for people with a type of lymph gland cancer called Hodgkin or non-Hodgkin Lymphoma or Lymphoepithelioma which has returne...

What is the current status of trial NCT00062868?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 74 participants. The study started on 2003-09. Estimated completion is 2020-04.

What conditions does trial NCT00062868 study?

This clinical trial studies the following conditions: Non Hodgkin Lymphoma, Hodgkin Disease, Leiomyosarcoma, Lymphoepithelioma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00062868?

The interventions under investigation include: LMP1/2 CTLs (ALCI - Group A) (BIOLOGICAL), LMP1/2 CTLs (ALCI - Group B) (BIOLOGICAL), LMP1/2 CTLs (ALCI - Group C) (BIOLOGICAL), LMP2 CTLs (ALSCER - Group A) (BIOLOGICAL), LMP2 CTLs (ALSCER - Group B) (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00062868?

This trial is sponsored by Baylor College of Medicine, which has 678 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00062868 being conducted?

This trial has 2 study locations across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial