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Cladribine High Dose
Cladribine is a purine nucleoside analog that depletes lymphocytes by being incorporated into DNA and causing strand breaks, leading to selective destruction of immune cells.
Cladribine is a purine nucleoside analog that depletes lymphocytes by being incorporated into DNA and causing strand breaks, leading to selective destruction of immune cells. Used for Hairy cell leukemia, Chronic lymphocytic leukemia, Multiple sclerosis (relapsing-remitting).
At a glance
| Generic name | Cladribine High Dose |
|---|---|
| Sponsor | Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany |
| Drug class | Purine nucleoside analog |
| Target | DNA (via deoxyadenosine analog incorporation) |
| Modality | Small molecule |
| Therapeutic area | Oncology, Immunology |
| Phase | Phase 3 |
Mechanism of action
Cladribine is a deoxyadenosine analog that is phosphorylated intracellularly and incorporated into DNA, causing double-strand breaks and apoptosis primarily in lymphocytes. It has preferential activity against T cells and B cells due to their high deoxycytidine kinase activity and low 5'-nucleotidase activity. The high-dose formulation is designed to achieve rapid lymphocyte depletion for immunosuppressive or anti-cancer effects.
Approved indications
- Hairy cell leukemia
- Chronic lymphocytic leukemia
- Multiple sclerosis (relapsing-remitting)
Common side effects
- Myelosuppression/neutropenia
- Lymphopenia
- Anemia
- Thrombocytopenia
- Infection
- Nausea
- Fever
Key clinical trials
- Efficacy and Safety of a New Formulation of Oral Cladribine Compared With Placebo in Participants With Generalized Myasthenia Gravis (MyClad) (PHASE3)
- IMPACT-AML: A Randomized Pragmatic Clinical Trial for Relapsed or Refractory Acute Myeloid Leukemia. (PHASE3)
- Cladribine Plus Low Dose Cytarabine (LDAC) Alternating With Decitabine in Patients With Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndrome (MDS) (PHASE2)
- Trial of DFP-10917 vs Non-Intensive or Intensive Reinduction for AML Patients in 2nd/3rd/4th Salvage (PHASE3)
- Best Available Therapy Versus Autologous Hematopoietic Stem Cell Transplant for Multiple Sclerosis (BEAT-MS) (PHASE3)
- A Phase II Study of Cladribine and Low Dose Cytarabine in Combination With Venetoclax, Alternating With Azacitidine and Venetoclax, in Patients With Higher-risk Myeloproliferative Chronic Myelomonocytic Leukemia or Higher-risk Myelodysplastic Syndromes With Excess Blasts (PHASE2)
- Cladribine Venetoclax in Monocytic AML (PHASE2)
- A Phase I Study Investigating the Combination of Cladribine, Low Dose Cytarabine and Sorafenib Alternating With Decitabine in Pediatric Relapsed and Refractory Acute Leukemias (PHASE1)
Primary sources
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| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |