Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00062868 · ClinicalTrials.gov registry record · Phase 1
LMP-specific T-cells for Patients With Relapsed EBV-positive Lymphoma
A Phase 1 study of Non-Hodgkin Lymphoma and Hodgkin Disease, sponsored by Baylor College of Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 74
- Enrollment target
- 2
- Study locations
NCT00062868 is a Phase 1 study of Non-Hodgkin Lymphoma and Hodgkin Disease that has completed, run by Baylor College of Medicine. The registered enrollment target is 74 participants, below the 151-participant average among 104 other Non-Hodgkin Lymphoma trials with a reported enrollment target (51% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT00062868, a Phase 1 study of Non-Hodgkin Lymphoma and Hodgkin Disease, has completed, sponsored by Baylor College of Medicine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 74 participants
- Enrollment target
- 2
- Study locations
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
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2003-09 |
| Est. Completion | 2020-04 |
| Phase | Phase 1 |
Interested in This Trial?
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, categorized as Phase 1. The registered enrollment target is 74 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 151-participant average among 104 other Non-Hodgkin Lymphoma trials with a reported enrollment target (51% lower). The listed sponsor is Baylor College of Medicine, which has 616 total studies on file at ClinicalTrials.gov.
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.
NCT00062868 reports 2 study locations spanning 1 distinct geographic area - top geographies include Texas.
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.
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).
Who is sponsoring clinical trial NCT00062868?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Non-Hodgkin Lymphoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
A Safety and Efficacy Study Evaluating CTX112 in Subjects With Relapsed or Refractory B-Cell Malignancies
RECRUITING · Phase 1
-
Study of Cytokine Release Syndrome Prophylaxis and Treatment With Siltuximab Prior to Epcoritamab
RECRUITING · Phase 1
-
Dose-escalation and Dose-expansion Study of Safety of Azer-cel (PBCAR0191) in Participants With Relapsed/Refractory (r/r) Non-Hodgkin Lymphoma (NHL) and r/r B-cell Acute Lymphoblastic Leukemia (B-ALL)
RECRUITING · Phase 1
-
Alpha/Beta CD19+ Depleted Haploidentical Transplantation + Zometa for Pediatric Hematologic Malignancies and Solid Tumors
RECRUITING · Phase 1
-
Preliminary Safety and Tolerability of CD19x22 CAR T Cells in Adolescent and Adult R/R B-NHL Patients
RECRUITING · Phase 1
-
Activated T-Cells Expressing 2nd or 3rd Generation CD19-Specific CAR, Advanced B-Cell NHL, ALL, and CLL (SAGAN)
RECRUITING · Phase 1
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.