ArticleBlood advances2022
INCB84344-201: Ponatinib and steroids in frontline therapy for unfit patients with Ph+ acute lymphoblastic leukemia.
Article in Blood advances, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01641107 (Front-line Treatment of Philadelphia Positive/BCR-ABL Positive Acute Lymphoblastic Leukemia With Ponatinib, a New Potent Tyrosine Kinase Inhibitor.), which is not on this map. Cited by 39 papers, 1 of them a synthesis that pooled it.
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.
Front-line Treatment of Philadelphia Positive/BCR-ABL Positive Acute Lymphoblastic Leukemia With Ponatinib, a New Potent Tyrosine Kinase Inhibitor.
Who cites it
39 citing papers in PubMed, 1 synthesis or guideline pooled it, 70 citations in OpenAlex.
- Efficacy of Chemotherapy-Free Regimens in the Treatment of Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia: A Systematic Review and Meta-Analysis.Clinical lymphoma, myeloma & leukemia · 2024Pooled it
- Trial
- Impact of clinical response and treatment tolerability on HRQoL in newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia patients treated with ponatinib or imatinib.Annals of hematology · 2025Trial
- Trial
- Olverembatinib: A New Treatment for Adult Patients with Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia.Cancers · 2026Review
- Optimal management of elderly/old PhHaematologica · 2026Article
- Article
- Toward a chemotherapy and allo-HSCT free future: the evolution of treatment for Philadelphia chromosome-positive acute lymphoblastic leukemia.Frontiers in immunology · 2026Review
- A critical review of management of allogeneic transplant-eligible adults with Ph+ acute lymphoblastic leukaemia.British journal of haematology · 2026Review
- Sanctuary sites and extramedullary relapses in the chemo-free world: insights from immunotherapies in B-ALL.Hematology. American Society of Hematology. Education Program · 2025Review
- [Chemotherapy-free induction therapy for a critically ill pregnant woman with Philadelphia chromosome-positive acute lymphoblastic leukemia: a case report and literature review].Zhonghua xue ye xue za zhi = Zhonghua xueyexue zazhi · 2025Review
- How I treat Ph+ acute lymphoblastic leukemia.Future oncology (London, England) · 2025Review
- Adult Acute Lymphoblastic Leukemia: 2025 Update on Diagnosis, Therapy, and Monitoring.American journal of hematology · 2025Review
- Review
- Asciminib plus dasatinib and prednisone for Philadelphia chromosome-positive acute leukemia.Blood · 2025Article
- Acute Lymphoid Leukemia: Is Transplant Indicated for Philadelphia Chromosome Positive ALL?Advances in experimental medicine and biology · 2025Review
- Ponatinib and prednisolone induce sustained remission in a relapsed case of mixed-phenotype acute leukemia withInternational cancer conference journal · 2025Article
- Ph+ ALL: new approaches for upfront therapy.Hematology. American Society of Hematology. Education Program · 2024Review
- Ponatinib-review of historical development, current status, and future research.American journal of hematology · 2024Review
- Ponalfil trial for adults with Philadelphia chromosome-positive acute lymphoblastic leukemia: Long-term results.HemaSphere · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
38 authors at 20 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Tyrosine kinase inhibitors have improved survival for patients with Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL). However, prognosis for old or unfit patients remains poor. In the INCB84344-201 (formerly GIMEMA LAL 1811) prospective, multicenter, phase 2 trial, we tested the efficacy and safety of ponatinib plus prednisone in newly diagnosed patients with Ph+ ALL ≥60 years, or unfit for intensive chemotherapy and stem cell transplantation. Forty-four patients received oral ponatinib 45 mg/d for 48 weeks (core phase), with prednisone tapered to 60 mg/m2/d from days-14-29. Prophylactic intrathecal chemotherapy was administered monthly. Median age was 66.5 years (range, 26-85). The primary endpoint (complete hematologic response [CHR] at 24 weeks) was reached in 38/44 patients (86.4%); complete molecular response (CMR) in 18/44 patients (40.9%) at 24 weeks. 61.4% of patients completed the core phase. As of 24 April 2020, median event-free survival was 14.31 months (95% CI 9.30-22.31). Median overall survival and duration of CHR were not reached; median duration of CMR was 11.6 months. Most common treatment-emergent adverse events (TEAEs) were rash (36.4%), asthenia (22.7%), alanine transaminase increase (15.9%), erythema (15.9%), and γ-glutamyltransferase increase (15.9%). Cardiac and vascular TEAEs occurred in 29.5% (grade ≥3, 18.2%) and 27.3% (grade ≥3, 15.9%), respectively. Dose reductions, interruptions, and discontinuations due to TEAEs occurred in 43.2%, 43.2%, and 27.3% of patients, respectively; 5 patients had fatal TEAEs. Ponatinib and prednisone showed efficacy in unfit patients with Ph+ ALL; however, a lower ponatinib dose may be more appropriate in this population. This trial was registered at www.clinicaltrials.gov as #NCT01641107.
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