Clinical trial · Interventional
Precision Diagnosis Directing HDACi Chidamide Target Therapy for Adult ETP-ALL
An Open-Label, One-Arm, Multi-Site Trial of Precision Diagnosis Directing Histone Deacetylase Inhibitor Chidamide Target Total Therapy for Adult Early T-cell Progenitor Acute Lymphoblastic Leukemia/Lymphoma
NCT03553238CI-TRIAL-00033296unknownPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
ETP-ALL is a recently recognized high-risk subgroup and the optimal therapeutic approaches are poorly characterized. Based on the pediatric-inspired, PEG-L-asparaginase-intensified and MRD-directed PDT-ALL-2016 protocol, this open-label, one-arm, multi-site trial is aimed to evaluate the safety and effect of a novel oral histone deacetylase inhibitor chidamide for adult ETP-ALL/LBL in CHINA.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia, Acute | Acute Leukemia | ONTOLOGY_EXACT | 0.90 |
| Leukemia, Lymphoblastic | Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| Leukemia, T Cell | Leukemia | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (20)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 6-Mercaptopurine | Drug | Mercaptopurine | ALIAS |
| Adriamycin | Drug | — | UNRESOLVED |
| allogeneic hematopoietic stem cell transplantation | Procedure | — | UNRESOLVED |
| Bone marrow aspiration | Procedure | — | UNRESOLVED |
| Chidamide | Drug | — | UNRESOLVED |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Cytarabine | Drug | Cytarabine | ALIAS |
| Dexamethasone | Drug | Dexamethasone | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ETP-ALL
- description
- Chidamide at a dose of 10mg/day will be added to PDT-ETP-ALL protocol. The intervention of PDT-ETP-ALL consists of diagnostic test (bone marrow aspiration, flow immunophenotyping, Karyotyping ，FISH, NGS, Flow-MRD, PET-CT scan), induction regimen (chidamide, dexamethasone, vincristine, cyclophosphamide, idarubicin, pegaspargase), consolidation regimen (chidamide, prednisone, cytarabine, methotrexate, cyclophosphamide, etoposide, adriamycin, 6-mercaptopurine, pegaspargase), MRD assessment and maintenance regimen (chidamide, prednisone, vincristine, methotrexate, 6-mercaptopurine), intrathecal injection chemotherapy, radiation therapy (for mediastinum- and/or central nervous system-involved lymphoma/leukemia) and allogeneic hematopoietic stem cell transplantation for patients with donor.
- interventionNames
- Drug: Chidamide
- Drug: Dexamethasone
- Drug: vincristine
- Drug: Cyclophosphamide
- Drug: Idarubicin
- Drug: Pegaspargase
- Drug: Adriamycin
- Drug: Methotrexate
- Drug: 6-Mercaptopurine
- Drug: Etoposide
- Drug: Cytarabine
- Procedure: Bone marrow aspiration
- Procedure: Intrathecal injection
- Radiation: Radiation therapy
- Genetic: NGS
- Procedure: allogeneic hematopoietic stem cell transplantation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 14 Years
- Maximum age
- 55 Years
Show eligibility criteria text
Inclusion Criteria: * 14-55 years old; * ETP-ALL newly diagnosed; * signed written informed consent Exclusion Criteria: * Pregnant women; * History of pancreatitis; * History of diabetes; * History of active peptic ulcer disease in the past 6 months; * History of arteriovenous thrombosis in the past 6 months; * Severe active infection; * Allergic to any drugs in PDT-ETP-ALL.
References
Publications (5)
- BACKGROUNDKoch U, Radtke F. Mechanisms of T cell development and transformation. Annu Rev Cell Dev Biol. 2011;27:539-62. doi: 10.1146/annurev-cellbio-092910-154008. Epub 2011 Jul 5. PMID 21740230
- BACKGROUNDArber DA, Orazi A, Hasserjian R, Thiele J, Borowitz MJ, Le Beau MM, Bloomfield CD, Cazzola M, Vardiman JW. The 2016 revision to the World Health Organization classification of myeloid neoplasms and acute leukemia. Blood. 2016 May 19;127(20):2391-405. doi: 10.1182/blood-2016-03-643544. Epub 2016 Apr 11. PMID 27069254
- BACKGROUNDBond J, Graux C, Lhermitte L, Lara D, Cluzeau T, Leguay T, Cieslak A, Trinquand A, Pastoret C, Belhocine M, Spicuglia S, Lheritier V, Lepretre S, Thomas X, Huguet F, Ifrah N, Dombret H, Macintyre E, Boissel N, Asnafi V. Early Response-Based Therapy Stratification Improves Survival in Adult Early Thymic Precursor Acute Lymphoblastic Leukemia: A Group for Research on Adult Acute Lymphoblastic Leukemia Study. J Clin Oncol. 2017 Aug 10;35(23):2683-2691. doi: 10.1200/JCO.2016.71.8585. Epub 2017 Jun 12. PMID 28605290
- BACKGROUNDYu S, Zhou X, Steinke FC, Liu C, Chen SC, Zagorodna O, Jing X, Yokota Y, Meyerholz DK, Mullighan CG, Knudson CM, Zhao DM, Xue HH. The TCF-1 and LEF-1 transcription factors have cooperative and opposing roles in T cell development and malignancy. Immunity. 2012 Nov 16;37(5):813-26. doi: 10.1016/j.immuni.2012.08.009. Epub 2012 Oct 25. PMID 23103132
- DERIVEDLin J, Huang Z, Cai Z, Li J, Li Z, Ding C, Wang Z, Li X, Zhou X, He B, Zhong W, Xuan L, Liu Q, Xu Y, Zhou H. Tucidinostat plus pediatric-inspired chemotherapy for newly diagnosed adult ETP-ALL/LBL: a single-arm, phase 2 trial. J Hematol Oncol. 2024 Oct 28;17(1):101. doi: 10.1186/s13045-024-01624-8. PMID 39468701