Last reviewed · How we verify
Fludarabin
At a glance
| Generic name | Fludarabin |
|---|---|
| Also known as | FLUDARA® |
| Sponsor | Azienda Ospedaliera San Giovanni Battista |
| Target | Carbonic anhydrase 5A, mitochondrial, DNA polymerase alpha catalytic subunit, Ribonucleoside-diphosphate reductase large subunit |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
Approved indications
- Acute myeloid leukemia, disease
- Chronic lymphoid leukemia, disease
- Low-grade B cell non-Hodgkin lymphoma
- Mantle cell lymphoma
Common side effects
- Neutropenia
- Anemia
- Thrombocytopenia
- Pneumonia
- Infection
- Fever and chills
- Nausea and vomiting
- Malaise
- Fatigue
- Anorexia
- Weakness
- Edema
Serious adverse events
- Autoimmune hemolytic anemia
- Tumor lysis syndrome
- Bone marrow fibrosis
- Trilineage bone marrow hypoplasia/aplasia
- Pancytopenia
- Pulmonary toxicity/ARDS
- Pulmonary hemorrhage
- Pulmonary fibrosis
- Hemorrhagic cystitis
- Pericardial effusion
Key clinical trials
- Study Investigating the Safety of CD19 CAR-T Cells in Relapsed/Refractory AML Expressing CD19 (PHASE1)
- Anti-NY-ESO-1 TCR-Gene Engineered Lymphocytes Given by Infusion to Patients With NY-ESO-1 -Expressing Metastatic Cancers (PHASE1, PHASE2)
- CAR-T Cell Therapy Targeting to CD19 for R/R ALL (PHASE1, PHASE2)
- Studyof Allogeneic Hematopoietic Stem Cell Transplantation From One Haplotype Mismatch Related Donor or From an Unrelated Donor in Elderly Patients (PHASE3)
- Personalized Targeted Preparative Regimen Before T-depleted Allogeneic HSCT in Children With Chemoresistent Acute Leukemias (PHASE3)
- Allo-hNHL (FluBuCy) (PHASE2)
- Thiotepa, Busulfan and Fludarabin for pt With Refractory/Early Relapsed Aggressive B-cell Non Hodgkin Lymphomas (PHASE2)
- PRO#0118: Decitabine Plus Mini Flu-Bu (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Fludarabin CI brief — competitive landscape report
- Fludarabin updates RSS · CI watch RSS
- Azienda Ospedaliera San Giovanni Battista portfolio CI