{"preliminary_commentary":{"by_channel":{"x_thread":3},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. This is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this."},"free_build":{"available":false},"commentary_summary":null,"drugs_tested":null,"indication":null,"name":"NCT03471260","nct_id":"NCT03471260","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct03471260. The price is an estimate of verified statements from the commentary indexed so far, fixed at order. Final coverage is set when the report is built. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"Patients receive venetoclax PO daily on days 1-14. Patients also receive ivosidenib PO daily on days 15-28 of cycle 1 and days 1-28 of subsequent cycles. Patients may also receive azacitidine IV over 30-60 minutes or SC on days 1-7. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.","label":"Treatment (venetoclax, ivosidenib, azacitidine)","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2027-09-30","type":"ESTIMATED"},"conditions":["Acute Myeloid Leukemia","Hematopoietic and Lymphoid System Neoplasm","Myelodysplastic Syndrome","Myeloproliferative Neoplasm","Recurrent Acute Myeloid Leukemia","Refractory Acute Myeloid Leukemia"],"enrollment":{"count":96,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"Azacitidine","otherNames":["5 AZC","5-AC","5-Azacytidine","5-AZC","Azacytidine","Azacytidine, 5-","Ladakamycin","Mylosar","Onureg","U-18496","Vidaza"],"type":"DRUG"},{"name":"Ivosidenib","otherNames":["AG-120","Tibsovo"],"type":"DRUG"},{"name":"Venetoclax","otherNames":["ABT-0199","ABT-199","ABT199","GDC-0199","RG7601","Venclexta","Venclyxto"],"type":"DRUG"}],"last_update":"2026-09-14","lead_sponsor":"M.D. Anderson Cancer Center","official_title":"Phase Ib/II Investigator Initiated Study of the IDH1-Mutant Inhibitor Ivosidenib (AG120) With the BCL2 Inhibitor Venetoclax +/- Azacitidine in IDH1-Mutated Hematologic Malignancies","overall_status":"RECRUITING","phases":["PHASE1","PHASE2"],"primary_completion_date":{"date":"2027-09-30","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Overall response rate (ORR)","timeFrame":"Up to 3 years"},{"measure":"Incidence of adverse events","timeFrame":"Up to 3 years"},{"measure":"Dose-limiting toxicity","timeFrame":"Up to 56 days"}],"references":[{"citation":"DiNardo CD, Marvin-Peek J, Loghavi S, Takahashi K, Issa GC, Jen WY, Daver NG, Reville PK, Short NJ, Sasaki K, Mullin JK, Bradley CA, Borthakur G, Maiti A, Alvarado Y, Pemmaraju N, Abbas HA, Hammond DE, Haddad F, Bravo GM, Chien KS, Yilmaz M, Kornblau SM, Jabbour E, Ravandi F, Kadia T, Garcia-Manero G, Konopleva MY, Kantarjian HM. Outcomes of Frontline Triplet Regimens With a Hypomethylating Agent, Venetoclax, and Isocitrate Dehydrogenase Inhibitor for Intensive Chemotherapy-Ineligible Patients With Isocitrate Dehydrogenase-Mutated AML. J Clin Oncol. 2025 Aug 20;43(24):2692-2699. doi: 10.1200/JCO-25-00640. Epub 2025 Jun 13.","pmid":"40513054","type":"DERIVED"},{"citation":"Greenberg PL, Stone RM, Abaza Y, Al-Kali A, Anand S, Ball B, Bennett JM, Borate U, Brunner AM, Chai-Ho W, Curtin P, DeZern AE, Gaensler K, Gahvari Z, Garcia-Manero G, Griffiths EA, Haque T, Jacoby M, Jonas BA, Keel S, Khanal R, Kishtagari A, Madanat Y, Maness LJ, McCurdy SR, McMahon C, Odenike O, Osman A, Reddy VV, Sallman DA, Sayar H, Shallis R, Singh A, Tanaka T, Thota S, Kovach E, Nguyen J, Hochstetler C. NCCN Guidelines(R) Insights: Myelodysplastic Syndromes, Version 2.2025. J Natl Compr Canc Netw. 2025 Mar;23(3):66-75. doi: 10.6004/jnccn.2025.0013.","pmid":"40073835","type":"DERIVED"},{"citation":"Wilde L, Kasner M. Whom should we treat with novel agents? Specific indications for specific and challenging populations. Hematology Am Soc Hematol Educ Program. 2021 Dec 10;2021(1):24-29. doi: 10.1182/hematology.2021000228.","pmid":"34889407","type":"DERIVED"}],"start_date":{"date":"2018-03-19","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Ivosidenib and Venetoclax With or Without Azacitidine in Treating Patients With IDH1 Mutated Hematologic Malignancies","url":"https://clinicaltrials.gov/study/NCT03471260"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.1","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/nct03471260"}