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NCT04608487

Axi-cel in CNS Lymphoma

Active, enrolled Phase 1 Last updated 30 July 2025
What this trial tests

Phase 1 trial testing Fludarabine in Lymphoma in 18 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
4 December 2020
Primary endpoint
14 June 2025
14 June 2038

Quick facts

Lead sponsorDana-Farber Cancer Institute
PhasePhase 1
StatusActive, enrolled
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment18
Start date4 December 2020
Primary completion14 June 2025
Estimated completion14 June 2038
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Dana-Farber Cancer Institute

Who can join

18 and older, any sex, with Lymphoma or Lymphoma Cns. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This research is being done to test the safety and effectiveness of axicabtagene ciloleucel (axi-cel), an anti-CD19 directed chimeric antigen receptor (CAR) T-cell therapy in treating relapsed/refractory central nervous system (CNS) lymphoma, systemic lymphoma with concurrent CNS lymphoma, or systemic lymphoma with a history of treated CNS lymphoma, and to better understand what causes neurological toxicity following treatment with axi-cel. The names of the study drug(s) involved in this study are: * axicabtagene ciloleucel (axi-cel) * ludarabine will be given with axicel to help axicel work more effectively * cyclophosphamide will be given with axicel to help axicel work more effectively

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. CAR-T cell therapy for cancer: current challenges and future directions.
    Zugasti I, Espinosa-Aroca L, Fidyt K, Mulens-Arias V, et al · · 2025 · cited 81× · PMID 40610404 · DOI 10.1038/s41392-025-02269-w
  2. Prevention and management of secondary central nervous system lymphoma.
    Bobillo S, Khwaja J, Ferreri AJM, Cwynarski K. · · 2023 · cited 47× · PMID 36384246 · DOI 10.3324/haematol.2022.281457
  3. CAR T-cell-associated neurotoxicity in central nervous system hematologic disease: Is it still a concern?
    Velasco R, Mussetti A, Villagrán-García M, Sureda A. · · 2023 · cited 39× · PMID 37090983 · DOI 10.3389/fneur.2023.1144414
  4. How I treat secondary CNS involvement by aggressive lymphomas.
    Alderuccio JP, Nayak L, Cwynarski K. · · 2023 · cited 22× · PMID 37702537 · DOI 10.1182/blood.2023020168
  5. CAR T-Cells for CNS Lymphoma: Driving into New Terrain?
    Karschnia P, Blobner J, Teske N, Schöberl F, et al · · 2021 · cited 19× · PMID 34065471 · DOI 10.3390/cancers13102503
  6. Emerging Approaches for Solid Tumor Treatment Using CAR-T Cell Therapy.
    Chung H, Jung H, Noh JY. · · 2021 · cited 18× · PMID 34830003 · DOI 10.3390/ijms222212126
  7. Update on Novel Therapeutics for Primary CNS Lymphoma.
    Schaff LR, Grommes C. · · 2021 · cited 15× · PMID 34771535 · DOI 10.3390/cancers13215372
  8. Recent Progress on Primary Central Nervous System Lymphoma-From Bench to Bedside.
    Shao L, Xu C, Wu H, Jamal M, et al · · 2021 · cited 13× · PMID 34485125 · DOI 10.3389/fonc.2021.689843

Verify or expand the search:

Other trials of Fludarabine

Trials testing the same drug.

Other recruiting trials for Lymphoma

Currently open trials in the same condition.

Other Dana-Farber Cancer Institute trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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