Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2020
Children's Oncology Group AALL0434: A Phase III Randomized Clinical Trial Testing Nelarabine in Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia.
Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 148 papers, 5 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
Intensified Methotrexate, Nelarabine (Compound 506U78) and Augmented BFM Therapy for Children and Young Adults With Newly Diagnosed T-cell Acute Lymphoblastic Leukemia (ALL) or T-cell Lymphoblastic Lymphoma
Venetoclax Combined With HAG Regimen in Treating Adult Relapse/Refractory Acute T Cell Lymphoblastic Leukemia/Lymphoma: A Phase II, Single Arm and Multicenter Study
Who cites it
148 citing papers in PubMed, 5 syntheses or guidelines pooled it, 248 citations in OpenAlex.
- American Society of Hematology 2026 guidelines for management of relapsed/refractory acute lymphoblastic leukemia in adolescents and young adults.Blood advances · 2026Guideline
- American Society of Hematology 2026 guidelines for frontline management of acute lymphoblastic leukemia in adolescents and young adults.Blood advances · 2026Guideline
- Nelarabine in T-cell acute lymphoblastic leukemia: intracellular metabolism and molecular mode-of-action.Leukemia · 2025Pooled it
- The efficacy and safety of nelarabine in relapsed or refractory T-cell acute lymphoblastic leukemia: a systematic review and meta-analysis.Annals of hematology · 2025Pooled it
- Efficacy and safety of nelarabine in patients with relapsed or refractory T-cell acute lymphoblastic leukemia: a systematic review and meta-analysis.Annals of hematology · 2022Pooled it
- Clinical and molecular prognostic factors in newly diagnosed pediatric T-cell lymphoblastic lymphoma: a prospective, multicenter, single-arm phase 2 clinical trial.World journal of pediatrics : WJP · 2026Trial
- Nelarabine-combined chemotherapy improves outcome of T-cell acute lymphoblastic leukemia but shows more severe neurotoxicity: JALSG T-ALL213-O.Cancer science · 2025Trial
- Trial
- Trial
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- Children's Oncology Group Trial AALL1231: A Phase III Clinical Trial Testing Bortezomib in Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia and Lymphoma.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2022Trial
- Trial
- Successful Outcomes of Newly Diagnosed T Lymphoblastic Lymphoma: Results From Children's Oncology Group AALL0434.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2020Trial
- Improved CNS Control of Childhood Acute Lymphoblastic Leukemia Without Cranial Irradiation: St Jude Total Therapy Study 16.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2019Trial
- Measurable Residual Disease.Methods in molecular biology (Clifton, N.J.) · 2027Article
- Understanding and clinical approach to early T-cell precursor acute lymphoblastic leukemia.Blood research · 2026Review
- Article
- T-lymphoblastic leukemia/lymphoma: a comprehensive review of pathology, molecular features, and differential diagnosis.Journal of pathology and translational medicine · 2026Article
- Targeting Menin in T-lineage Acute Lymphoblastic Leukemia.Molecular cancer therapeutics · 2026Article
- Health-related Quality of Life in children and adolescents treated for acute lymphoblastic leukaemia (ALL), compared with healthy peers: a longitudinal study of early survivorship.Journal of cancer survivorship : research and practice · 2026Article
88 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
21 authors at 19 institutions in 3 countries.
Funding
Abstract
purposeNelarabine is effective in inducing remission in patients with relapsed and refractory T-cell acute lymphoblastic leukemia (T-ALL) but has not been fully evaluated in those with newly diagnosed disease. PATIENTS AND
methodsFrom 2007 to 2014, Children's Oncology Group trial AALL0434 (ClinicalTrials.gov identifier: NCT00408005) enrolled 1,562 evaluable patients with T-ALL age 1-31 years who received the augmented Berlin-Frankfurt-Muenster (ABFM) regimen with a 2 × 2 pseudo-factorial randomization to receive escalating-dose methotrexate (MTX) without leucovorin rescue plus pegaspargase (C-MTX) or high-dose MTX (HDMTX) with leucovorin rescue. Intermediate- and high-risk patients were also randomly assigned after induction to receive or not receive six 5-day courses of nelarabine that was incorporated into ABFM. Patients who experienced induction failure were nonrandomly assigned to HDMTX plus nelarabine. Patients with overt CNS disease (CNS3; ≥ 5 WBCs/μL with blasts) received HDMTX and were randomly assigned to receive or not receive nelarabine. All patients, except those with low-risk disease, received cranial irradiation.
resultsThe 5-year event-free and overall survival rates were 83.7% ± 1.1% and 89.5% ± 0.9%, respectively. The 5-year disease-free survival (DFS) rates for patients with T-ALL randomly assigned to nelarabine (n = 323) and no nelarabine (n = 336) were 88.2% ± 2.4% and 82.1% ± 2.7%, respectively (
conclusionThe addition of nelarabine to ABFM therapy improved DFS for children and young adults with newly diagnosed T-ALL without increased toxicity.
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Identifiers
What OpenQuestion holds
Registered trials
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.