Testing Drug Treatments After CAR T-cell Therapy in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma (NCT05633615)

🧪 Interventions in This Study

• Axicabtagene Ciloleucel (BIOLOGICAL)
• Cyclophosphamide (DRUG)
• Fludarabine (DRUG)
• Lisocabtagene Maraleucel (BIOLOGICAL)
• Mosunetuzumab (BIOLOGICAL)
• Polatuzumab Vedotin (DRUG)
• Tisagenlecleucel (BIOLOGICAL)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. STEP 1: REGISTRATION: Participants must have a histologically confirmed diagnosis of diffuse large B-cell lymphoma or follicular lymphoma grade 3b or primary mediastinal large B-cell lymphoma (PMBCL)
2. STEP 1: REGISTRATION: Participants with transformed DLBCL must have transformed DLBCL from follicular or marginal zone lymphoma
3. STEP 1: REGISTRATION: Participant must have bi-dimensionally measurable systemic disease (at least one lesion with longest diameter \> 1.5 cm)
4. STEP 1: REGISTRATION: Participants with secondary central nervous system (CNS) lymphoma (parenchymal, spinal cord, meningeal, cerebrospinal fluid involvement) must be asymptomatic from their CNS disease
5. STEP 1: REGISTRATION: Participants must be registered for step 1 after they have signed institutional consent for CAR T-cell leukapheresis but prior to the start of lymphodepleting (LD) chemotherapy for commercial CAR T-cell product
6. STEP 1: REGISTRATION: In the opinion of the enrolling physician, participants must be felt to be a candidate for CAR T-cell therapy with plans to be treated with Food and Drug Administration (FDA) approved commercially available CD19 CAR T-cell construct.
7. Participants must qualify for commercially approved CD19 CAR T-cell therapy per FDA package insert.
8. If the CAR T-cell product does not meet parameters to be given as an FDA approved product (i.e. does not meet specification criteria mandated by FDA and is infused under an expanded access protocol \[EAP\] or single participant investigational new drug \[IND\]) the participant will be taken off of study and no longer be eligible for step 2 randomization
9. STEP 1: REGISTRATION: Participants are permitted to receive or have received 'bridging therapy' after CAR T-cell leukapheresis. However, participants must not receive polatuzumab vedotin, and/or mosunetuzumab as part of bridging therapy.
10. Bridging therapy is defined as lymphoma directed therapy administered between leukapheresis and the start of LD chemotherapy. This includes cytotoxic chemotherapy (e.g.: bendamustine and rituximab \[BR\], rituximab, gemcitabine and oxaliplatin \[R-gem/ox\]), radiation, corticosteroids, as well as novel therapies such as BTK inhibitors (e.g.: Ibrutinib), immunomodulators (e.g.: lenalidomide), monoclonal antibodies (e.g.: rituximab, obinutuzumab, tafasitamab) antibody drug conjugates (e.g: loncastuximab), checkpoint inhibitors (e.g.: pembrolizumab, nivolumab), clinical trial treatments, etc.
11. If a participant receives polatuzumab vedotin or mosunetuzumab as bridging they will ineligible to continue on step 1 registration portion of the study and be ineligible for step 2 randomization
12. STEP 1: REGISTRATION: PET-CT scan must be planned for completion within 60 days prior to the start of LD chemotherapy.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (87 Sites)

Showing the first 25 of 87 sites.

• Banner University Medical Center - Tucson — Tucson, Arizona
• University of Arizona Cancer Center-North Campus — Tucson, Arizona
• Highlands Oncology Group - Fayetteville — Fayetteville, Arkansas
• University of Arkansas for Medical Sciences — Little Rock, Arkansas
• Highlands Oncology Group - Rogers — Rogers, Arkansas
• Highlands Oncology Group — Springdale, Arkansas
• UC Irvine Health Cancer Center-Newport — Costa Mesa, California
• UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care — Irvine, California
• UCI Health Laguna Hills — Laguna Hills, California
• UC Irvine Health/Chao Family Comprehensive Cancer Center — Orange, California
• UCSF Medical Center-Parnassus — San Francisco, California
• UF Health Cancer Institute - Gainesville — Gainesville, Florida
• Emory University Hospital/Winship Cancer Institute — Atlanta, Georgia
• Emory Saint Joseph's Hospital — Atlanta, Georgia
• Saint Luke's Cancer Institute - Boise — Boise, Idaho
• Saint Luke's Cancer Institute - Fruitland — Fruitland, Idaho
• Saint Luke's Cancer Institute - Meridian — Meridian, Idaho
• Saint Luke's Cancer Institute - Nampa — Nampa, Idaho
• Saint Luke's Cancer Institute - Twin Falls — Twin Falls, Idaho
• University of Illinois — Chicago, Illinois
• University of Chicago Comprehensive Cancer Center — Chicago, Illinois
• Loyola University Medical Center — Maywood, Illinois
• University of Iowa/Holden Comprehensive Cancer Center — Iowa City, Iowa
• University of Kansas Cancer Center — Kansas City, Kansas
• University of Kansas Cancer Center-Overland Park — Overland Park, Kansas

📞 Contact the Study Coordinator

Phone: (210) 614-8808

Email: erogers@swog.org

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Diffuse Large B-Cell Lymphoma

• Tafasitamab + Lenalidomide + R-CHOP Versus R-CHOP in Newly Diagnosed High-intermediate and High Risk DLBCL Patients — Daphne, Alabama
• A Study to Evaluate Change in Disease Activity of Subcutaneous (SC) Epcoritamab Combined With Intravenous and Oral Rituximab, Cyclophosphamide, Doxorubicin Hydrochloride, Vincristine, and Prednisone (R-CHOP) or R-CHOP in Adult Participants With Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL) — Tucson, Arizona
• Testing the Addition of a New Anti-cancer Drug, Venetoclax, to Usual Chemotherapy for High Grade B-cell Lymphomas — Birmingham, Alabama
• A Combination of Acalabrutinib With R-CHOP in Subjects With Previously Untreated Non-GCB DLBCL (ACE-LY-312) — Tucson, Arizona
• A Study of Brentuximab Vedotin, Rituximab, and Dose Attenuated CHP in Elderly Patients With Diffuse Large B-Cell Lymphoma (DLBCL) — Rochester, New York

Explore by condition: All Diffuse Large B-Cell Lymphoma clinical trials

💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Contact the study coordinator using the phone/email above.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.