NCT01318317Active, not recruitingPhase 1/2
Genetically Engineered Lymphocyte Therapy After Peripheral Blood Stem Cell Transplant in Treating Patients With High-Risk, Intermediate-Grade, B-cell Non-Hodgkin Lymphoma
Phase I/II Study of Cellular Immunotherapy Using Central Memory-Enriched CD8+ T Cells Lentivirally Transduced to Express A CD19-Specific Chimeric Immunoreceptor Following Peripheral Blood Stem Cell Transplantation for Patients With High-Risk Intermediate Grade B-Lineage Non-Hodgkin Lymphoma
Source: ClinicalTrials.gov · Last updated 11 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 8 (actual)
- First submitted
- 16 Mar 2011
- Start date
- Oct 2011
- Primary completion date
- Oct 2013
- Lead sponsor
- City of Hope Medical Center
- Diseases
- Follicular lymphoma, Mantle cell lymphoma
- NCT number
- NCT01318317
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 8
- From Oct 2011 to the primary completion date, Oct 2013
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Dependence on corticosteroids
- Currently enrolled in another investigational therapy protocol
- History of allogeneic HSCT or prior autologous HSCT
Other illness
- Human immunodeficiency virus (HIV) seropositive based on testing performed within 4 weeks of enrollment
- Active autoimmune disease requiring systemic immunosuppressive therapy
- Research participant(s) with known active hepatitis B or C infection
Other
- Fails to understand the basic elements of the protocol and/or the risks/benefits of participating in this phase I/II study; evidence of understanding includes passing the Protocol Comprehensive Screening given by the Research Subject Advocate (RSA); a legal guardian may substitute for the research participant
- Any standard contraindications to myeloablative HSCT per standard of care practices at COH
- Research participant(s) who are to receive radioimmunotherapy (Zevalin-based)-based conditioning regimens
Who the study is looking for
- City of Hope (COH) pathology review confirms that research participant's diagnostic material is consistent with history of intermediate grade B-cell NHL (e.g., diffuse B-cell lymphoma, mantle cell lymphoma, transformed follicular lymphoma)
- History of relapse after achieving first remission with primary therapy, or failure to achieve remission with primary therapy
- Life expectancy \> 16 weeks
- Karnofsky performance scale (KPS) \>= 70%
- Negative serum pregnancy test for women of childbearing potential
- Research participant has an indication to be considered for autologous stem cell transplantation
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| City of Hope Medical Center Coordinator of this site? Confirm its status | Duarte | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.