Trial reportBlood2026
TRANSFORM-1 phase 3 study: efficacy and safety of navitoclax plus ruxolitinib in patients with untreated myelofibrosis.
Trial report in Blood, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04472598 (A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Of Navitoclax In Combination With Ruxolitinib Versus Ruxolitinib In Subjects With Myelofibrosis), which is not on this map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Of Navitoclax In Combination With Ruxolitinib Versus Ruxolitinib In Subjects With Myelofibrosis (TRANSFORM-1)
Who cites it
1 citing paper in PubMed.
- Megakaryocytes in myelofibrosis: mechanisms of fibrotic niche remodeling and therapeutic implications.Biomarker research · 2026Review
Corrections and comments
- Commented on by
Authors and funding
29 authors.
Funding
Abstract
abstractThe phase 3 TRANSFORM-1 study evaluated ruxolitinib (RUX) in combination with navitoclax (NAV) or placebo (PBO) in Janus kinase inhibitor-naïve adults with intermediate-2 or high-risk myelofibrosis and Eastern Cooperative Oncology Group performance status of ≤2. Patients were randomized 1:1 to NAV (200 mg/d starting dose, or 100 mg escalated to 200 mg/d) or PBO, with RUX dosed per label. The primary end point was ≥35% spleen volume reduction (SVR) at week 24 (SVR35W24). Secondary end points included change from baseline in total symptom score (TSS) at week 24 and SVR35 at any time. A total of 252 patients (NAV+RUX, n = 125; PBO+RUX, n = 127; median follow-up 20.3 months) were randomized; >80% had intermediate-2 risk, and ∼50% had high-molecular risk disease. SVR35W24 was achieved by 63.2% with NAV+RUX vs 31.5% with PBO+RUX (P< .0001). Mean change in TSS at week 24 was not significantly different between NAV+RUX and PBO+RUX (-10.2 vs -11.6; P = .2852). SVR35 at any time was achieved in 76.8% with NAV+RUX vs 44.1% with PBO+RUX (nominal P< .0001). A ≥20% variant allele frequency reduction (exploratory end point) occurred in 58.5% (95% confidence interval [CI], 49.0-67.5) with NAV+RUX and 45.5% (95% CI, 36.4-54.8) with PBO+RUX. NAV+RUX showed higher hematologic toxicity vs PBO+RUX (grade 3/4 thrombocytopenia, 54.0% vs 19.2%; grade 3/4 neutropenia, 40.3% vs 8.8%); diarrhea (any grade, 41.9% vs 16.8%) was also more common. Cytopenias were generally manageable and reversible with dose adjustments. This trial was registered at www.clinicaltrials.gov as NCT04472598.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.