{"preliminary_commentary":{"by_channel":{"youtube":32,"podcast":21,"x_thread":20,"x_video":1},"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":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT04472598\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's free public preview; the full report is still bought."},"commentary_summary":null,"name":"TRANSFORM-1","nct_id":"NCT04472598","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=transform-1-nct04472598. 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":1950,"size":"deep","size_rule":"Deep: 301+ verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":"TRANSFORM-1","arms":[{"description":"Placebo for navitoclax tablets were administered orally once daily (QD) per Baseline platelet count (\\>150 × 10\\^9/L starting dose of 200 mg; ≤150 × 10\\^9/L starting dose of 100 mg, which could be increased to 200 mg QD after 7 days provided platelet count is ≥75 × 10\\^9/L). Placebo for navitoclax didn't exceed 200 mg QD for first 24 weeks of treatment. After Week 25, Day 1 visit, placebo for navitoclax dose may be increased to 300 mg QD at Investigator's discretion for those with suboptimal spleen response defined as failure to achieve spleen volume reduction of at least 10% per imaging. Ruxolitinib tablets were administered orally twice daily (BID) per Baseline platelet count (\\>200 × 10\\^9/L starting dose of 20 mg; 100-200 × 10\\^9/L starting dose of 15 mg). Participants will continue their treatment until end of clinical benefit, unacceptable toxicity, or they meet other protocol criteria for discontinuation (whichever occurs first).","label":"Placebo for Navitoclax + Ruxolitinib","type":"ACTIVE_COMPARATOR"},{"description":"Navitoclax tablets were administered orally once daily (QD) per Baseline platelet count (\\>150 × 10\\^9/L starting dose of 200 mg; ≤150 × 10\\^9/L starting dose of 100 mg, which could be increased to 200 mg QD after 7 days provided platelet count is ≥75 × 10\\^9/L). Navitoclax didn't exceed 200 mg QD for first 24 weeks of treatment. After Week 25, Day 1 visit, navitoclax dose may be increased to 300 mg QD at Investigator's discretion for those with suboptimal spleen response defined as failure to achieve spleen volume reduction of at least 10% per imaging. Ruxolitinib tablets were administered orally twice daily (BID) per Baseline platelet count (\\>200 × 10\\^9/L starting dose of 20 mg; 100-200 × 10\\^9/L starting dose of 15 mg). Participants will continue their treatment until end of clinical benefit, unacceptable toxicity, or they meet other protocol criteria for discontinuation (whichever occurs first).","label":"Navitoclax + Ruxolitinib","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2025-01-29","type":"ACTUAL"},"conditions":["Myelofibrosis (MF)"],"enrollment":{"count":252,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Placebo for Navitoclax","otherNames":[],"type":"DRUG"},{"name":"Ruxolitinib","otherNames":["Jakafi"],"type":"DRUG"},{"name":"Navitoclax","otherNames":["ABT-263"],"type":"DRUG"}],"last_update":"2026-03-23","lead_sponsor":"AbbVie","official_title":"A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Of Navitoclax In Combination With Ruxolitinib Versus Ruxolitinib In Subjects With Myelofibrosis (TRANSFORM-1)","overall_status":"COMPLETED","phases":["PHASE3"],"primary_completion_date":{"date":"2023-04-13","type":"ACTUAL"},"primary_outcomes":[{"measure":"Percentage of Participants With ≥ 35% Reduction From Baseline in Spleen Volume at Week 24 (SVR35W24)","timeFrame":"Baseline, Week 24"}],"references":[{"citation":"Pemmaraju N, Mead AJ, Somervaille TCP, Palandri F, Koschmieder S, Delage R, Kiladjian JJ, Benton C, Tantravahi SK, Lavi N, Yeh SP, Gomez Casares MT, Ammatuna E, McDonald A, Yoon SS, Kirito K, Devos T, Perkins A, Radinoff A, Sevindik OG, Bogdanovic A, Moskal R, Harb JG, Murray B, Jiang Q, Chopra AS, Papadopoulos EJ, Potluri J, Passamonti F. TRANSFORM-1 phase 3 study: efficacy and safety of navitoclax plus ruxolitinib in patients with untreated myelofibrosis. Blood. 2026 Oct 15;148(16):2029-2042. doi: 10.1182/blood.2025032360.","pmid":"42378247","type":"DERIVED"}],"start_date":{"date":"2020-09-29","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Study of Oral Navitoclax Tablet In Combination With Oral Ruxolitinib Tablet When Compared With Oral Ruxolitinib Tablet To Assess Change In Spleen Volume In Adult Participants With Myelofibrosis","url":"https://clinicaltrials.gov/study/NCT04472598"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/transform-1-nct04472598"}