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Clinical trial · no report yet · Phase 3
AALL0434
Combination Chemotherapy in Treating Young Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma
- NCT00408005 ↗
- Completed
- National Cancer Institute (NCI)
- Focused
We haven't built an HCP commentary report on AALL0434 (newly diagnosed T-cell acute lymphoblastic leukemia or lymphoma) yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.
Indexed commentary on AALL0434 so far
Podcasts, YouTube videos and X posts we have indexed that name the trial. It is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this.
| Channel | Indexed | |
|---|---|---|
| X threads | 3 |
The trial
ClinicalTrials.gov- Official title
- 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
- Phase
- Phase 3
- Status
- Completed
- Conditions
- T Acute Lymphoblastic Leukemia; T Lymphoblastic Lymphoma
- Interventions
- Asparaginase; Cyclophosphamide; Cytarabine; Daunorubicin Hydrochloride; Dexamethasone; Doxorubicin Hydrochloride; Laboratory Biomarker Analysis; Leucovorin Calcium; Mercaptopurine; Methotrexate; Nelarabine; Pegaspargase; Prednisone; Radiation Therapy; Thioguanine; Vincristine Sulfate
- Arms
- Group 0 Induction Therapy · Experimental
- Group 1 Arm IV (Consolidation chemotherapy) · Active comparator
- Group I Arm I (Consolidation chemotherapy) · Active comparator
- Group I Arm I (Delayed intensification chemotherapy · Active comparator
- Group I Arm I (Maintenance chemotherapy) · Active comparator
- Group I Arm I (Interim maintenance chemotherapy) · Active comparator
- Group I Arm II (Consolidation chemotherapy) · Active comparator
- Group I Arm II (Delayed intensification chemotherapy) · Active comparator
- Group I Arm II (Interim maintenance chemotherapy) · Active comparator
- Group I Arm II (Maintenance chemotherapy) · Active comparator
- Group I Arm III (Consolidation chemotherapy) · Active comparator
- Group I Arm III (Delayed intensification chemotherapy) · Active comparator
- Group I Arm III (Interim maintenance chemotherapy) · Active comparator
- Group I Arm III (Maintenance chemotherapy) · Active comparator
- Group I Arm IV (Delayed intensification chemotherapy) · Active comparator
- Group I Arm IV (Interim maintenance chemotherapy) · Active comparator
- Group I Arm IV (Maintenance chemotherapy) · Active comparator
- Enrollment
- 1,895
- Primary outcomes
- Disease-free Survival (DFS) for Randomized Nelarabine T-ALL Cohort (Arm I vs. Arm II vs. Arm III vs. Arm IV)
- Disease-free Survival (DFS) for Randomized Nelarabine T-ALL Cohort (Arm I + Arm III vs. Arm II + Arm IV)
- Disease-free Survival (DFS) for Randomized Methotrexate T-ALL Cohort (Arm I vs. Arm II vs. Arm III vs. Arm IV)
- Disease-free Survival (DFS) for Randomized Methotrexate T-ALL Cohort (Arm I + Arm II vs. Arm III + Arm IV)
- Disease-free Survival (DFS) for T-cell Lymphoblastic Lymphoma (T-LLy) Cohort
- Sponsor
- National Cancer Institute (NCI)
- Start
- Jan 30, 2007
- Primary completion
- Sep 30, 2017
- Results posted
- Yes
- Registry record
- NCT00408005 · updated Jun 23, 2026
Publications
linked from the registry- Orgel E, Maese LD, Devidas M, Militano O, Rau RE, Angiolillo AL, McNeer JL, Schore RJ, Borowitz MJ, Wood B, Raetz EA, Silverman LB, Winick NJ, Larsen EC, Carroll WL, Winter SS, Dunsmore KP, Hunger SP, Loh ML. Toxicity from asparaginase during acute lymphoblastic leukemia induction: a report from the Children's Oncology Group. Blood Adv. 2026 Jul 28;10(14):4923-4930. doi: 10.1182/bloodadvances.2026019870. PubMed 42085640
- Pinton A, Courtois L, Delafoy M, Bonnet M, Cieslak A, Lhermitte L, Simonin M, Dourthe ME, Touzart A, Andrieu GP, Dombret H, Baruchel A, Spicuglia S, Payet-Bornet D, Boissel N, Macintyre E, Asnafi V. Homeodomain-driven oncogenic diversion to a gammadeltaTCR phenotype in T-cell acute lymphoblastic leukemia. Blood. 2026 Jun 4;147(23):2793-2808. doi: 10.1182/blood.2025030626. PubMed 41592282
- Xu J, Teachey DT. Genomic Classification of T-Cell Acute Lymphoblastic Leukemia: Current Paradigms and Future Biomarkers. J Natl Compr Canc Netw. 2025 Jun 18;23(7):e257028. doi: 10.6004/jnccn.2025.7028. PubMed 40533067
- Wood BL, Devidas M, Summers RJ, Chen Z, Asselin B, Rabin KR, Zweidler-McKay PA, Winick NJ, Borowitz MJ, Carroll WL, Raetz EA, Loh ML, Hunger SP, Dunsmore KP, Teachey DT, Winter SS. Prognostic significance of ETP phenotype and minimal residual disease in T-ALL: a Children's Oncology Group study. Blood. 2023 Dec 14;142(24):2069-2078. doi: 10.1182/blood.2023020678. PubMed 37556734
- Gossai NP, Devidas M, Chen Z, Wood BL, Zweidler-McKay PA, Rabin KR, Loh ML, Raetz EA, Winick NJ, Burke MJ, Carroll AJ, Esiashvili N, Heerema NA, Carroll WL, Hunger SP, Dunsmore KP, Winter SS, Teachey DT. Central nervous system status is prognostic in T-cell acute lymphoblastic leukemia: a Children's Oncology Group report. Blood. 2023 Apr 13;141(15):1802-1811. doi: 10.1182/blood.2022018653. PubMed 36603187
- Gaynon PS, Parekh C. A new standard of care for childhood T-cell acute lymphoblastic leukemia? Pediatr Blood Cancer. 2021 Oct;68(10):e29238. doi: 10.1002/pbc.29238. Epub 2021 Jul 24. No abstract available. PubMed 34302711
- Dunsmore KP, Winter SS, Devidas M, Wood BL, Esiashvili N, Chen Z, Eisenberg N, Briegel N, Hayashi RJ, Gastier-Foster JM, Carroll AJ, Heerema NA, Asselin BL, Rabin KR, Zweidler-Mckay PA, Raetz EA, Loh ML, Schultz KR, Winick NJ, Carroll WL, Hunger SP. Children's Oncology Group AALL0434: A Phase III Randomized Clinical Trial Testing Nelarabine in Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia. J Clin Oncol. 2020 Oct 1;38(28):3282-3293. doi: 10.1200/JCO.20.00256. Epub 2020 Aug 19. PubMed 32813610
- Hayashi RJ, Winter SS, Dunsmore KP, Devidas M, Chen Z, Wood BL, Hermiston ML, Teachey DT, Perkins SL, Miles RR, Raetz EA, Loh ML, Winick NJ, Carroll WL, Hunger SP, Lim MS, Gross TG, Bollard CM. Successful Outcomes of Newly Diagnosed T Lymphoblastic Lymphoma: Results From Children's Oncology Group AALL0434. J Clin Oncol. 2020 Sep 10;38(26):3062-3070. doi: 10.1200/JCO.20.00531. Epub 2020 Jun 17. PubMed 32552472
- Winter SS, Dunsmore KP, Devidas M, Wood BL, Esiashvili N, Chen Z, Eisenberg N, Briegel N, Hayashi RJ, Gastier-Foster JM, Carroll AJ, Heerema NA, Asselin BL, Gaynon PS, Borowitz MJ, Loh ML, Rabin KR, Raetz EA, Zweidler-Mckay PA, Winick NJ, Carroll WL, Hunger SP. Improved Survival for Children and Young Adults With T-Lineage Acute Lymphoblastic Leukemia: Results From the Children's Oncology Group AALL0434 Methotrexate Randomization. J Clin Oncol. 2018 Oct 10;36(29):2926-2934. doi: 10.1200/JCO.2018.77.7250. Epub 2018 Aug 23. PubMed 30138085