{"id":"azacitidine-combined-to-lenalidomide","safety":{"commonSideEffects":[{"rate":null,"effect":"Myelosuppression (neutropenia, thrombocytopenia, anemia)"},{"rate":null,"effect":"Infection"},{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Nausea and vomiting"},{"rate":null,"effect":"Diarrhea"},{"rate":null,"effect":"Thromboembolism (lenalidomide-related)"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"anthropic-haiku","explanation":"Azacitidine is a hypomethylating agent that inhibits DNA methyltransferase, reversing aberrant DNA methylation and reactivating silenced tumor suppressor genes. Lenalidomide is an immunomodulatory drug that enhances T-cell proliferation and NK cell activity while promoting degradation of specific proteins. The combination targets both the epigenetic abnormalities and immune dysfunction characteristic of myelodysplastic syndromes.","oneSentence":"Azacitidine and lenalidomide work together to restore normal gene expression in myelodysplastic syndrome cells through DNA methylation inhibition and immunomodulation.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T02:30:19.586Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Myelodysplastic syndrome (MDS), including higher-risk MDS"}]},"trialDetails":[{"nctId":"NCT01522976","phase":"PHASE2","title":"Azacitidine With or Without Lenalidomide or Vorinostat in Treating Patients With Higher-Risk Myelodysplastic Syndromes or Chronic Myelomonocytic Leukemia","status":"ACTIVE_NOT_RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2012-03-01","conditions":"Chronic Myelomonocytic Leukemia, Chronic Myelomonocytic Leukemia-1, Chronic Myelomonocytic Leukemia-2","enrollment":282},{"nctId":"NCT04068597","phase":"PHASE1, PHASE2","title":"Study to Evaluate CCS1477 (Inobrodib) in Haematological Malignancies","status":"RECRUITING","sponsor":"CellCentric Ltd.","startDate":"2019-08-09","conditions":"Haematological Malignancy, Acute Myeloid Leukemia, Non Hodgkin Lymphoma","enrollment":250},{"nctId":"NCT06803693","phase":"PHASE2","title":"Efficacy and Safety of Pola-RCHP-X vs Pola-RCHP in Untreated DLBCL","status":"RECRUITING","sponsor":"Ruijin Hospital","startDate":"2025-04-01","conditions":"Diffuse Large B-Cell Lymphoma","enrollment":152},{"nctId":"NCT04257448","phase":"PHASE1, PHASE2","title":"Safety and Tolerance of Epigenetic and Immunomodulating Drugs Combined With Chemotherapeutics in Patients Suffering From Advanced Pancreatic Cancer","status":"COMPLETED","sponsor":"GWT-TUD GmbH","startDate":"2020-05-25","conditions":"Pancreas Cancer, Pancreatic Adenocarcinoma, Pancreatic Ductal Adenocarcinoma","enrollment":75},{"nctId":"NCT04578600","phase":"PHASE1","title":"CC-486, Lenalidomide, and Obinutuzumab for the Treatment of Recurrent or Refractory CD20 Positive B-cell Lymphoma","status":"COMPLETED","sponsor":"Joseph Tuscano","startDate":"2020-10-23","conditions":"Indolent B-Cell Non-Hodgkin Lymphoma, Recurrent B-Cell Non-Hodgkin Lymphoma, Recurrent Chronic Lymphocytic Leukemia","enrollment":8},{"nctId":"NCT06441097","phase":"PHASE2","title":"Efficacy of Pola-RCHP-X vs Pola-RCHP in Untreated DLBCL","status":"NOT_YET_RECRUITING","sponsor":"Ruijin Hospital","startDate":"2024-12-31","conditions":"Diffuse Large B-Cell Lymphoma","enrollment":152},{"nctId":"NCT06004765","phase":"PHASE4","title":"Efficacy and Safety of Lenalidomide Combined With Azacitidine vs Azacitidine in the Treatment of MDS-RS","status":"UNKNOWN","sponsor":"Peking Union Medical College Hospital","startDate":"2023-08","conditions":"Myelodysplastic Syndromes","enrollment":138},{"nctId":"NCT01241786","phase":"PHASE2","title":"Study Examining the Combination of Revlimid (Lenalidomide)and Vidaza (Azacitidine) for Relapsed/Refractory CLL and SLL","status":"TERMINATED","sponsor":"Hackensack Meridian Health","startDate":"2010-07","conditions":"Chronic Lymphocytic Leukemia(CLL), Small Lymphocytic Lymphoma","enrollment":5},{"nctId":"NCT04490707","phase":"PHASE3","title":"Study of Azacytidine Combined With Lenalidomide As Maintenance Therapy Based on MRD Monitoring in AML","status":"UNKNOWN","sponsor":"Ge Zheng","startDate":"2020-09-01","conditions":"Acute Myeloid Leukemia in Remission","enrollment":60},{"nctId":"NCT01379274","phase":"PHASE2","title":"A Trial of Lenalidomide & Azacitidine in Low Risk Myelodysplastic Syndromes","status":"TERMINATED","sponsor":"Rush University Medical Center","startDate":"2011-01","conditions":"MDS","enrollment":2},{"nctId":"NCT01155583","phase":"PHASE1, PHASE2","title":"Low-Dose Azacitidine, Lenalidomide, and Low-Dose Dexamethasone in Relapsed or Refractory Multiple Myeloma","status":"COMPLETED","sponsor":"Case Comprehensive Cancer Center","startDate":"2010-06","conditions":"Refractory Multiple Myeloma","enrollment":45},{"nctId":"NCT02265510","phase":"PHASE1, PHASE2","title":"An Open-Label Study of a Novel JAK-inhibitor, INCB052793, Given to Patients With Advanced Malignancies","status":"TERMINATED","sponsor":"Incyte Corporation","startDate":"2014-09-10","conditions":"Solid Tumors, Advanced Malignancies, Metastatic Cancer","enrollment":83},{"nctId":"NCT01358734","phase":"PHASE2","title":"A Study Being Conducted at Multiple Locations to Compare Safety and Efficacy of Three Different Regimens; (1) High-Dose Lenalidomide; (2) Lenalidomide + Azacitidine; or (3) Azacitidine in Subjects ≥ 65 Years With Newly-Diagnosed Acute Myeloid Leukemia","status":"COMPLETED","sponsor":"Celgene","startDate":"2012-04-27","conditions":"Acute Myeloid Leukemia, Acute Myelogenous Leukemia","enrollment":88},{"nctId":"NCT00352001","phase":"PHASE1, PHASE2","title":"Lenalidomide and Azacitidine in Treating Patients With Advanced Myelodysplastic Syndromes","status":"COMPLETED","sponsor":"Mikkael Sekeres MD","startDate":"2006-05","conditions":"Leukemia, Myelodysplastic Syndromes","enrollment":37},{"nctId":"NCT00890929","phase":"PHASE1, PHASE2","title":"Phase 1-2 of Azacitidine + Lenalidomide for Previously Untreated Elderly Patients With Acute Myeloid Leukemia (AML)","status":"COMPLETED","sponsor":"Stanford University","startDate":"2009-04","conditions":"Acute Myeloid Leukemia (AML), Adult Acute Myeloblastic Leukemia","enrollment":45},{"nctId":"NCT01442714","phase":"PHASE2","title":"Azacitidine + Lenalidomide Combo in the Elderly With Previously Treated AML & High-Risk MDS","status":"TERMINATED","sponsor":"Stanford University","startDate":"2011-08","conditions":"Leukemia, Acute Myeloid Leukemia (AML), Myelodysplastic Syndromes (MDS)","enrollment":33},{"nctId":"NCT01088373","phase":"PHASE2","title":"Lenalidomide Combined to Azacitidine in Intermediate-2 or High Risk MDS With Del 5q","status":"COMPLETED","sponsor":"Groupe Francophone des Myelodysplasies","startDate":"2010-03-25","conditions":"Myelodysplastic Syndromes","enrollment":50},{"nctId":"NCT01038635","phase":"PHASE1, PHASE2","title":"5-Azacytidine With Lenalidomide in Patients With High Risk Myelodysplastic Syndrome (MDS) and Acute Myelogenous Leukemia (AML)","status":"COMPLETED","sponsor":"M.D. Anderson Cancer Center","startDate":"2009-12","conditions":"Leukemia","enrollment":94},{"nctId":"NCT01556477","phase":"PHASE2","title":"The Efficacy of Azacitidine +/- Lenalidomide in High-risk Myelodysplastic Syndrome (MDS)and Acute Myeloid Leukemia (AML) With Del(5q).","status":"UNKNOWN","sponsor":"Nordic MDS Group","startDate":"2012-03","conditions":"Myelodysplastic Syndrome, Acute Myelogenous Leukemia","enrollment":72}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":94,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Vidaza.","Revlimid."],"phase":"phase_2","status":"active","brandName":"Azacitidine combined to Lenalidomide","genericName":"Azacitidine combined to Lenalidomide","companyName":"Groupe Francophone des Myelodysplasies","companyId":"groupe-francophone-des-myelodysplasies","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Azacitidine and lenalidomide work together to restore normal gene expression in myelodysplastic syndrome cells through DNA methylation inhibition and immunomodulation. Used for Myelodysplastic syndrome (MDS), including higher-risk MDS.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}