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Drug

Fludarabine

In clinical development
Emerging researchLate-stage developmentCooling momentum
Also known as 2-F-ARAA, 2-fluoro ARA-A, Oforta, Fludarabina+2 more

2-F-ARAA, 2-fluoro ARA-A, Oforta, Fludarabina, Fludarabine Phosphate, Fludarabinum.

RxNorm24698ChEMBLCHEMBL1568UNIIP2K93U8740
8
Research papers
62
Active clinical trials
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Phase 1 Trial of Umbilical Cord Blood Natural Killer Cells (CB-NK) Expressing Soluble IL-15 (sIL-15) and PD-L1 +/- Atezolizumab in Non-Small Cell Lung Cancer Patients Refractory to PD-1/PD-L1 Immune Checkpoint Inhibitors

Clinical trial2026-07-17Results expected Q2 2027 · ClinicalTrials.gov

A Phase 2 Study of SNDX-5613 in Combination With Chemotherapy for Patients With Relapsed or Refractory KMT2A-Rearranged Infant Leukemia

Clinical trial2026-07-16Results expected Q4 2027 · ClinicalTrials.gov

A Phase I Trial of Anti-CD19 and Anti-CD20 Bicistronic Chimeric Antigen Receptor T- Cells for Treating B-cell Malignancies

Clinical trial2026-07-16Results expected Q4 2028 · ClinicalTrials.gov

Phase 3 Open-label, Multicenter, Randomized Study of ASP2215 Versus Salvage Chemotherapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FLT3 Mutation

Clinical trial2026-07-16Results posted · ClinicalTrials.gov

A Phase 3, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy of KITE-753 Versus Axicabtagene Ciloleucel in Participants With Relapsed or Refractory Large B-Cell Lymphoma After First-Line Therapy

Clinical trial2026-07-15Results expected Q2 2031 · ClinicalTrials.gov

A Phase II Study of Allogeneic Hematopoietic Stem Cell Transplant for Subjects With VEXAS (Vacuoles, E1 Enzyme, X-linked, Autoinflammatory, Somatic) Syndrome

Clinical trial2026-07-10Results expected Q3 2031 · ClinicalTrials.gov

Phase I Trial of IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors

Clinical trial2026-07-10Results expected Q1 2028 · ClinicalTrials.gov

Administration of T Cells Expressing Chondroitin-Sulfate-Proteoglycan-4 Specific Chimeric Antigen Receptors (CAR) in Subjects With Head and Neck Squamous Cell Carcinoma (HNSCC)

Clinical trial2026-07-08Results expected Q3 2026 · ClinicalTrials.gov

CD19 CAR T-Cell Therapy in Autoimmune Disease - A Case Series with Follow-up.

Research2024-02-01The New England journal of medicine

KTE-X19 CAR T-Cell Therapy in Relapsed or Refractory Mantle-Cell Lymphoma.

Research2020-04-01The New England journal of medicine

Ibrutinib-Rituximab or Chemoimmunotherapy for Chronic Lymphocytic Leukemia.

Research2019-08-01The New England journal of medicine

Long-term safety and activity of axicabtagene ciloleucel in refractory large B-cell lymphoma (ZUMA-1): a single-arm, multicentre, phase 1-2 trial.

Research2018-12-02The Lancet. Oncology

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Fludarabine
Aliases & brands
2-F-ARAA2-fluoro ARA-AOfortaFludarabinaFludarabine PhosphateFludarabinum
RxNorm CUI
24698
ChEMBL ID
CHEMBL1568
UNII
P2K93U8740

Clinical trials

198 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
198
registered trials across all phases
LATEST COMPLETION 2026
62
Active studies
45
Recruiting
21
Late-stage (III+)
71
Completed
65
Discontinued
PHASE DISTRIBUTIONn = 198
Early Phase 16Phase 173Phase 1 / 235Phase 263Phase 2 / 33Phase 37Phase 43Phase N / A8

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Safety and Feasibility Study of Chimeric Antigen Receptor (CAR) T Cell Therapy With YESCARTA in the Outpatient Setting

CompletedPH IVVanderbilt-Ingram Cancer Centern=252023

Prospective Randomized Study to Compare Efficacy and Safety of RFC-Lite (Rituximab, Fludarabine, Cyclophosphamide) Regimen With LR (Rituximab, Chlorambucil) as a First-Line Therapy in Patients With B-Cell Chronic Lymphocytic Leukemia and Unfavorable Somatic Status

TerminatedPH IVHoffmann-La Rochen=262016

Treatment of Elderly Patients (>60 Years) With Acute Myeloblastic Leukemia or Advanced MDS (RAEB-T): An Open Randomized Study to Test the Efficacy of G-CSF-Priming and a Feasibility Trial of Dose-Reduced Allogeneic Transplantation and of Autologous Stem Cell Transplantation

Unknown statusPH IVJohann Wolfgang Goethe University Hospitaln=2502005

A Phase 3 Randomized Study Comparing Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Ciltacabtagene Autoleucel Versus Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Autologous Stem Cell Transplant (ASCT) in Participants With Newly Diagnosed Multiple Myeloma Who Are Transplant Eligible

Active, not recruitingPH IIIStichting European Myeloma Networkn=7592040

An Adaptive, Operationally Seamless Phase II / III Study of 131I-apamistamab-Led Allogeneic Hematopoietic Stem Cell Transplant in Patients With Relapsed or Refractory Acute Myeloid Leukemia With Active Disease

Not yet recruitingPH II/IIIActinium Pharmaceuticalsn=3062034

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Phase I/II Trial in Patients With Metastatic Gastrointestinal Epithelial Cancer Administering Tumor-Infiltrating Lymphocytes in Which the Gene Encoding CISH Was Inactivated Using the CRISPR/Cas9 System

CompletedPH I/IIIntima Bioscience, Inc.n=232026

A PHASE IB STUDY OF IMMUNOTHERAPY WITH EX VIVO PRE-ACTIVATED AND EXPANDED CB-NK CELLS IN COMBINATION WITH CETUXIMAB, IN COLORECTAL CANCER PATIENTS WITH MINIMAL RESIDUAL DISEASE (MRD)

CompletedPH IM.D. Anderson Cancer Centern=152026

Reduced Dose Fludarabine/Cyclophosphamide Lymphodepletion Before Tumor-Infiltrating Lymphocyte Therapy With Lifileucel in Metastatic Melanoma

CompletedPH IIUniversity of Kansas Medical Centern=112025

Hematopoietic Cell Transplantation in the Treatment of Infant Leukemia and Myelodysplastic Syndrome

CompletedPH IIMasonic Cancer Center, University of Minnesotan=342025

A Single-Arm, Open-Label, Phase 1 Study of the Safety, Efficacy, and Cellular Kinetics/Pharmacodynamics of ALLO-715 to Evaluate an Anti-BCMA Allogeneic CAR T Cell Therapy With or Without Nirogacestat in Subjects With Relapsed/Refractory Multiple Myeloma

CompletedPH IAllogene Therapeuticsn=732025

Phase 1/2, Open-label Study Evaluating Safety of Repeat Administration of Ad/PNP-F-araAMP (Ad/PNP Administered Intratumorally Followed by Intravenous Fludarabine Phosphate) in Subjects With Recurrent, Local Head and Neck Cancer

CompletedPH I/IIGeoVax, Inc.n=102024

Research activity

8 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
19992024
Most influential

Long-term safety and activity of axicabtagene ciloleucel in refractory large B-cell lymphoma (ZUMA-1): a single-arm, multicentre, phase 1-2 trial.

The Lancet. Oncology · 2019 · 1,761 cites

KTE-X19 CAR T-Cell Therapy in Relapsed or Refractory Mantle-Cell Lymphoma.

The New England journal of medicine · 2020 · 1,377 cites

Adoptive cell therapy for patients with metastatic melanoma: evaluation of intensive myeloablative chemoradiation preparative regimens.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2008 · 1,043 cites

CD19 CAR T-Cell Therapy in Autoimmune Disease - A Case Series with Follow-up.

The New England journal of medicine · 2024 · 704 cites

Ibrutinib-Rituximab or Chemoimmunotherapy for Chronic Lymphocytic Leukemia.

The New England journal of medicine · 2019 · 563 cites

A phase 2 study of concurrent fludarabine and rituximab for the treatment of marginal zone lymphomas.

British journal of haematology · 2009 · 58 cites
Recent papers

CD19 CAR T-Cell Therapy in Autoimmune Disease - A Case Series with Follow-up.

The New England journal of medicine · 2024 · 704 cites

KTE-X19 CAR T-Cell Therapy in Relapsed or Refractory Mantle-Cell Lymphoma.

The New England journal of medicine · 2020 · 1,377 cites

Long-term safety and activity of axicabtagene ciloleucel in refractory large B-cell lymphoma (ZUMA-1): a single-arm, multicentre, phase 1-2 trial.

The Lancet. Oncology · 2019 · 1,761 cites

Ibrutinib-Rituximab or Chemoimmunotherapy for Chronic Lymphocytic Leukemia.

The New England journal of medicine · 2019 · 563 cites

Fludarabine-based conditioning for marrow transplantation from unrelated donors in severe aplastic anemia: early results of a cyclophosphamide dose deescalation study show life-threatening adverse events at predefined cyclophosphamide dose levels.

Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation · 2012 · 38 cites

A phase 2 study of concurrent fludarabine and rituximab for the treatment of marginal zone lymphomas.

British journal of haematology · 2009 · 58 cites
Major research themes8
Immunotherapy, Adoptive2Adoptive Transfer1Antigens, CD191Bone Marrow Transplantation1Immunotherapy1Lupus Erythematosus, Systemic1Lymphocyte Depletion1Myeloablative Agonists1
Journals, researchers & institutions
Top journals
  • The New England journal of medicine3
  • Annals of oncology : official journal of the European Society for Medical Oncology1
  • Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation1
  • British journal of haematology1
  • Journal of clinical oncology : official journal of the American Society of Clinical Oncology1
  • The Lancet. Oncology1
Leading researchers
  • Flinn IW2
  • Goy A2
  • Hill BT2
  • Jacobson CA2
  • Locke FL2
  • McSweeney PA2
  • Miklos DB2
  • Munoz J2
Leading institutions
free-text, unnormalised
  • Dana-Farber Cancer Institute2
  • and the Institute of Clinical Microbiology1
  • Banner MD Anderson Cancer Center1
  • City of Hope National Medical Center1
  • Cleveland Clinic Foundation1
  • Colorado Blood Cancer Institute1

Related drugs

5 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Vidarabine

Studied across 11 of the same disease areas as Fludarabine in the shared literature.

11 shared diseases5 shared papers
Cyclophosphamide

Studied across 11 of the same disease areas as Fludarabine in the shared literature.

11 shared diseases4 shared papers
Axicabtagene ciloleucel

Studied across 3 of the same disease areas as Fludarabine in the shared literature.

3 shared diseases1 shared paper
Adenine

Studied across the same disease area as Fludarabine in the shared literature.

1 shared disease1 shared paper
Ibrutinib

Studied across the same disease area as Fludarabine in the shared literature.

1 shared disease1 shared paper
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials