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Low-dose cytarabine (LDAC)
Low-dose cytarabine is a nucleoside analog that inhibits DNA synthesis by incorporating into DNA and blocking cell division, primarily affecting rapidly dividing hematopoietic cells.
Low-dose cytarabine is a nucleoside analog that inhibits DNA synthesis by incorporating into DNA and blocking cell division, primarily affecting rapidly dividing hematopoietic cells. Used for Acute myeloid leukemia (AML) in elderly or unfit patients, Myelodysplastic syndrome (MDS).
At a glance
| Generic name | Low-dose cytarabine (LDAC) |
|---|---|
| Sponsor | Celgene |
| Drug class | Nucleoside analog; antimetabolite |
| Target | DNA synthesis; cytidine metabolism |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Cytarabine is a cytidine analog that is phosphorylated intracellularly and incorporated into DNA, disrupting DNA synthesis and causing cell death. At low doses, it preferentially affects myelodysplastic and leukemic cells while sparing normal hematopoiesis to some degree. The mechanism involves both direct cytotoxicity and potential differentiation-promoting effects in certain myeloid malignancies.
Approved indications
- Acute myeloid leukemia (AML) in elderly or unfit patients
- Myelodysplastic syndrome (MDS)
Common side effects
- Myelosuppression (neutropenia, thrombocytopenia, anemia)
- Infection
- Nausea and vomiting
- Fatigue
- Diarrhea
- Mucositis
Key clinical trials
- Cladribine Plus Low Dose Cytarabine (LDAC) Alternating With Decitabine in Patients With Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndrome (MDS) (PHASE2)
- Safety and Tolerability of Ziftomenib Combinations in Patients With Relapsed/Refractory Acute Myeloid Leukemia (PHASE1)
- Uproleselan, Cladribine, and Low Dose Cytarabine for the Treatment of Patients With Treated Secondary Acute Myeloid Leukemia (PHASE1, PHASE2)
- Venetoclax, Cladribine, Low Dose Cytarabine, and Azacitidine in Treating Patients With Previously Untreated Acute Myeloid Leukemia (PHASE2)
- Prospective Non-interventional Study of Adult Patients With Acute Myeloid Leukemia (AML)
- A Study of Venetoclax in Combination With Low Dose Cytarabine Versus Low Dose Cytarabine Alone in Treatment Naive Patients With Acute Myeloid Leukemia Who Are Ineligible for Intensive Chemotherapy (PHASE3)
- FHD-286 as Monotherapy or Combination Therapy in Subjects With Advanced Hematologic Malignancies (PHASE1)
- An Efficacy and Safety Study of AG-221 (CC-90007) Versus Conventional Care Regimens in Older Subjects With Late Stage Acute Myeloid Leukemia Harboring an Isocitrate Dehydrogenase 2 Mutation (PHASE3)
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:
- Low-dose cytarabine (LDAC) CI brief — competitive landscape report
- Low-dose cytarabine (LDAC) updates RSS · CI watch RSS
- Celgene portfolio CI