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NCT01318317 · ClinicalTrials.gov registry record · Phase 1
Genetically Engineered Lymphocyte Therapy After Peripheral Blood Stem Cell Transplant in Treating Patients With High-Risk, Intermediate-Grade, B-cell Non-Hodgkin Lymphoma
A Phase 1 study of Recurrent Mantle Cell Lymphoma and Recurrent Non-Hodgkin Lymphoma, sponsored by City of Hope Medical Center.
- Active
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
- 1
- Study location
NCT01318317 is a Phase 1 study of Recurrent Mantle Cell Lymphoma and Recurrent Non-Hodgkin Lymphoma that is active but no longer recruiting, run by City of Hope Medical Center. The registered enrollment target is 8 participants, below the 38-participant average among 27 other Recurrent Mantle Cell Lymphoma trials with a reported enrollment target (79% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01318317, a Phase 1 study of Recurrent Mantle Cell Lymphoma and Recurrent Non-Hodgkin Lymphoma, is active but no longer recruiting, sponsored by City of Hope Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I/II trial studies the side effects and best dose of genetically engineered lymphocyte therapy and to see how well it works after peripheral blood stem cell transplant (PBSCT) in treating patients with high-risk, intermediate-grade, B-cell non-Hodgkin lymphoma (NHL). Genetically engineered lymphocyte therapy may stimulate the immune system in different ways and stop cancer cells from growing. Giving rituximab together with chemotherapy before a PBSCT stops the growth of cancer cells by stopping them from dividing or killing them. Giving colony-stimulating factors, such as filgrastim (G-CSF), or plerixafor helps stem cells move from the bone marrow to the blood so they can be collected and stored. More chemotherapy or radiation therapy is given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. Giving genetically engineered lymphocyte therapy after PBSCT may be an effective treatment for NHL.
Conditions Studied
Interventions
- OTHER Laboratory Biomarker Analysis
- BIOLOGICAL Filgrastim
- PROCEDURE Peripheral Blood Stem Cell Transplantation
- PROCEDURE Autologous Hematopoietic Stem Cell Transplantation
- BIOLOGICAL Genetically Engineered Lymphocyte Therapy
Study Locations (1)
California
- City of Hope Medical Center - Duarte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2011-09-19 |
| Est. Completion | 2026-02-26 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01318317
The ClinicalTrials.gov registry entry for NCT01318317 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 38-participant average among 27 other Recurrent Mantle Cell Lymphoma trials with a reported enrollment target (79% lower). The listed sponsor is City of Hope Medical Center, which has 582 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Recurrent Mantle Cell Lymphoma appearing as the primary indexed condition, and to 5 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT01318317 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT01318317 about?
NCT01318317 is a clinical study titled "Genetically Engineered Lymphocyte Therapy After Peripheral Blood Stem Cell Transplant in Treating Patients With High-Risk, Intermediate-Grade, B-cell Non-Hodgkin Lymphoma". This phase I/II trial studies the side effects and best dose of genetically engineered lymphocyte therapy and to see how well it works after peripheral blood stem cell transplant (PBSCT) in treating patients with high-risk, intermediate-grade, B-cell non-Hodgkin lymphoma (NHL). Genetically engineere...
What is the current status of trial NCT01318317?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2011-09-19. Estimated completion is 2026-02-26.
What conditions does trial NCT01318317 study?
This clinical trial studies the following conditions: Recurrent Mantle Cell Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Grade 1 Follicular Lymphoma, Recurrent Grade 2 Follicular Lymphoma, Recurrent Grade 3 Follicular Lymphoma.
What interventions are being tested in trial NCT01318317?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Filgrastim (BIOLOGICAL), Peripheral Blood Stem Cell Transplantation (PROCEDURE), Autologous Hematopoietic Stem Cell Transplantation (PROCEDURE), Genetically Engineered Lymphocyte Therapy (BIOLOGICAL).
Who is sponsoring clinical trial NCT01318317?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01318317 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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