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NCT01815749 · ClinicalTrials.gov registry record · Phase 1
Genetically Modified T-cell Infusion Following Peripheral Blood Stem Cell Transplant in Treating Patients With Recurrent or High-Risk Non-Hodgkin Lymphoma
A Phase 1 study of Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue and Nodal Marginal Zone B-cell Lymphoma, sponsored by City of Hope Medical Center.
- Active
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT01815749: Active Phase 1 study of Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue and Nodal Marginal Zone B-cell Lymphoma, sponsored by City of Hope Medical Center.
NCT01815749 is a Phase 1 study of Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue and Nodal Marginal Zone B-cell Lymphoma that is active but no longer recruiting, run by City of Hope Medical Center. The registered enrollment target is 30 participants, below the 52-participant average among 11 other Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue trials with a reported enrollment target (42% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01815749, a Phase 1 study of Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue and Nodal Marginal Zone B-cell Lymphoma, is active but no longer recruiting, sponsored by City of Hope Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I trial studies the side effects and best dose of genetically modified T-cells following peripheral blood stem cell transplant in treating patients with recurrent or high-risk non-Hodgkin lymphoma. Giving chemotherapy before a stem cell transplant helps stop the growth of cancer cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Removing the T cells from the donor cells before transplant may stop this from happening. Giving an infusion of the donor's T cells (donor lymphocyte infusion) later may help the patient's immune system see any remaining cancer cells as not belonging in the patient's body and destroy them (called graft-versus-tumor effect)
Primary Outcome
Tables will be created to summarize all toxicities and side effects by dose, course, organ, and severity.
Conditions Studied
Interventions
- OTHER laboratory biomarker analysis
- PROCEDURE autologous hematopoietic stem cell transplantation
- BIOLOGICAL autologous CD19CAR-CD28-CD3zeta-EGFRt-expressing Tcm-enriched T cells
Study Locations (1)
California
- City of Hope Medical Center - Duarte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2013-10-08 |
| Est. Completion | 2026-06-01 |
| Phase | Phase 1 |
What the registry record for NCT01815749 still lists
NCT01815749 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 52-participant average among 11 other Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue trials with a reported enrollment target (42% lower).
The record links to 10 conditions, with Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue appearing as the primary indexed condition, and to 3 interventions - of which laboratory biomarker analysis is the first listed.
NCT01815749 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT01815749 about?
NCT01815749 is a clinical study titled "Genetically Modified T-cell Infusion Following Peripheral Blood Stem Cell Transplant in Treating Patients With Recurrent or High-Risk Non-Hodgkin Lymphoma". This phase I trial studies the side effects and best dose of genetically modified T-cells following peripheral blood stem cell transplant in treating patients with recurrent or high-risk non-Hodgkin lymphoma. Giving chemotherapy before a stem cell transplant helps stop the growth of cancer cells. Wh...
What is the current status of trial NCT01815749?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2013-10-08. Estimated completion is 2026-06-01.
What conditions does trial NCT01815749 study?
This clinical trial studies the following conditions: Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Nodal Marginal Zone B-cell Lymphoma, Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Adult Burkitt Lymphoma, Cutaneous B-cell Non-Hodgkin Lymphoma.
What interventions are being tested in trial NCT01815749?
The interventions under investigation include: laboratory biomarker analysis (OTHER), autologous hematopoietic stem cell transplantation (PROCEDURE), autologous CD19CAR-CD28-CD3zeta-EGFRt-expressing Tcm-enriched T cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT01815749?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01815749 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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