Genetically Engineered Lymphocyte Therapy After Peripheral Blood Stem Cell Transplant in Treating Patients With High-Risk, Intermediate-Grade, B-cell Non-Hodgkin Lymphoma

• Status: Active, not recruiting
• Trial end date: 2022-08-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: City of Hope Medical Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: JM 3100; Plerixafor; Rituximab

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• Dependence on corticosteroids

• Currently enrolled in another investigational therapy protocol

• Human immunodeficiency virus (HIV) seropositive based on testing performed within 4 weeks of enrollment

• History of allogeneic HSCT or prior autologous HSCT

• Active autoimmune disease requiring systemic immunosuppressive therapy

• Research participant(s) who are to receive radioimmunotherapy (Zevalin-based)

• based conditioning regimens

• Research participant(s) with known active hepatitis B or C infection