{"id":"cladribine-low-dose","safety":{"commonSideEffects":[{"rate":null,"effect":"Lymphopenia"},{"rate":null,"effect":"Infections"},{"rate":null,"effect":"Anemia"},{"rate":null,"effect":"Thrombocytopenia"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Headache"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Cladribine is a deoxyadenosine analog that is phosphorylated intracellularly and incorporated into DNA, leading to strand breaks and cell death. It preferentially affects lymphocytes due to their high deoxycytidine kinase activity and low 5'-nucleotidase activity. The low-dose formulation is designed to achieve sustained lymphocyte depletion while minimizing toxicity to other cell populations.","oneSentence":"Cladribine is a purine nucleoside analog that depletes lymphocytes by inhibiting ribonucleotide reductase and inducing apoptosis in dividing cells.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:06:14.100Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Multiple sclerosis (relapsing-remitting and progressive forms)"},{"name":"Lymphoproliferative disorders"}]},"trialDetails":[{"nctId":"NCT06463587","phase":"PHASE3","title":"Efficacy and Safety of a New Formulation of Oral Cladribine Compared With Placebo in Participants With Generalized Myasthenia Gravis (MyClad)","status":"RECRUITING","sponsor":"Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany","startDate":"2024-06-25","conditions":"Generalized Myasthenia Gravis","enrollment":264},{"nctId":"NCT06713837","phase":"PHASE3","title":"IMPACT-AML: A Randomized Pragmatic Clinical Trial for Relapsed or Refractory Acute Myeloid Leukemia.","status":"RECRUITING","sponsor":"Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. 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Treatment of Newly Diagnosed Monocytic AML and Active Signaling Mutated AML","status":"RECRUITING","sponsor":"OHSU Knight Cancer Institute","startDate":"2025-01-03","conditions":"Acute Monocytic Leukemia, Acute Myeloid Leukemia","enrollment":40},{"nctId":"NCT06474663","phase":"PHASE1","title":"A Phase I Study Investigating the Combination of Cladribine, Low Dose Cytarabine and Sorafenib Alternating With Decitabine in Pediatric Relapsed and Refractory Acute Leukemias","status":"WITHDRAWN","sponsor":"M.D. Anderson Cancer Center","startDate":"2025-07-31","conditions":"Refractory Acute Leukemia, Relapsed Acute Leukemia","enrollment":""},{"nctId":"NCT05766514","phase":"PHASE2","title":"Trial of Cladribine and Low-Dose Cytarabine (LoDAC) Alternating With Decitabine vs. Hypomethylating Agents (HMA) Plus Venetoclax as Frontline Therapy for AML or High-Grade MDS in Patients Unfit for Intensive Induction","status":"WITHDRAWN","sponsor":"University of 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Wisconsin","startDate":"2024-08-31","conditions":"Relapsed Adult AML, Refractory AML","enrollment":""},{"nctId":"NCT04776213","phase":"PHASE4","title":"Cognition and HRQoL in Adults With Highly-active RMS in Year 3 and 4 After Initial Mavenclad® Dose (CLARIFY MS Extension)","status":"COMPLETED","sponsor":"Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany","startDate":"2021-02-23","conditions":"Multiple Sclerosis","enrollment":280},{"nctId":"NCT03882203","phase":"PHASE2","title":"CLAGE Sequential With Flu-Bu Conditioning for Refractory Acute Leukemia","status":"COMPLETED","sponsor":"Shanghai Jiao Tong University School of Medicine","startDate":"2018-08-01","conditions":"Refractory Hematologic Cancer, Allogeneic Stem Cell Transplantation","enrollment":18},{"nctId":"NCT02665065","phase":"PHASE3","title":"Study of Iomab-B vs. Conventional Care in Older Subjects With Active, Relapsed or Refractory Acute Myeloid 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KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany","companyId":"merck-healthcare-kgaa-darmstadt-germany-an-affiliate-of-merck-kgaa-darmstadt-ger","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Cladribine is a small molecule DNA inhibitor used in the treatment of various conditions, including Acute Myeloid Leukemia (AML) and Refractory Hematologic Cancer. It is typically administered as part of a combination therapy, such as in the study NCT07423104, which investigated its use in conjunction with low dose cytarabine and venetoclax for relapsed or refractory AML.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}