NCT03564704

Precision Diagnosis Directing HDACi Chidamide Target Therapy for Adult T-LBL/ALL

Status unknown Phase 2, PHASE3 Last updated 21 June 2018

What this trial tests

Phase 2, PHASE3 trial testing Dexamethasone in Leukemia in 80 participants. Status unknown.

Timeline

14 February 2016

Primary endpoint
30 May 2021

30 May 2021

Quick facts

Lead sponsor	Nanfang Hospital, Southern Medical University
Phase	Phase 2, PHASE3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	80
Start date	14 February 2016
Primary completion	30 May 2021
Estimated completion	30 May 2021
Sites	1 location across China

Drugs / interventions tested

• Dexamethasone (dexamethasone) — full drug profile →
• vincristine (vincristine) — full drug profile →
• Cyclophosphamide (cyclophosphamide) — full drug profile →
• Idarubicin (IDARUBICIN) — full drug profile →
• Pegaspargase
• Adriamycin
• Methotrexate
• 6-mercaptopurine.
• Etoposide
• Cytarabine — full drug profile →
• Bone marrow aspiration
• Intrathecal injection
• Radiation therapy
• NGS
• allogeneic hematopoietic stem cell transplantation
• Flow-MRD
• FISH
• Flow immunophenotyping
• Karyotyping
• Chidamide
• PET-CT scan

Conditions studied

• Leukemia — all drugs for Leukemia →
• Leukemia, Acute — all drugs for Leukemia, Acute →
• Adult Lymphoblastic Lymphoma — all drugs for Adult Lymphoblastic Lymphoma →
• Leukemia, Lymphoblastic — all drugs for Leukemia, Lymphoblastic →

Sponsor

Nanfang Hospital, Southern Medical University

Who can join

Adults 14 to 55, any sex, with Leukemia or Leukemia, Acute. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Based on the pediatric-inspired, PEG-L-asparaginase-intensified and MRD-directed PDT-ALL-2016 protocol, this open-label, one-arm, multi-site trial PDT-ALL-LBL is aimed to evaluate the safety and effect of oral histone deacetylase inhibitor chidamide for adult T-ALL/LBL. Compared to PDT-ALL-2016 for B-ALL, HDACi chidamide will be administrated from induction therapy to maintenance therapy, along with higher dose of consolidation regimen of cytarabine, methotrexate, cyclophosphamide.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. The Physiopathology of T- Cell Acute Lymphoblastic Leukemia: Focus on Molecular Aspects.
   Fattizzo B, Rosa J, Giannotta JA, Baldini L, et al · · 2020 · cited 45× · PMID 32185137 · DOI 10.3389/fonc.2020.00273
2. How metabolism bridles cytotoxic CD8⁺ T cells through epigenetic modifications.
   Van Acker HH, Ma S, Scolaro T, Kaech SM, et al · · 2021 · cited 24× · PMID 33867272 · DOI 10.1016/j.it.2021.03.006
3. The Burgeoning Significance of Liquid-Liquid Phase Separation in the Pathogenesis and Therapeutics of Cancers.
   Xu WX, Qu Q, Zhuang HH, Teng XQ, et al · · 2024 · cited 17× · PMID 38481812 · DOI 10.7150/ijbs.92988
4. Early T-Cell Precursor Leukemia Has a Higher Risk of Induction-Related Infection among T-Cell Acute Lymphoblastic Leukemia in Adult.
   Huang K, Dai M, Li Q, Liu N, et al · · 2020 · cited 9× · PMID 33424437 · DOI 10.1155/2020/8867760
5. Immunosenescence: Molecular Mechanisms, Diseases, and Therapeutic Innovations.
   Gong N, Pan X, Deng Y, Che J, et al · · 2025 · cited 4× · PMID 41427020 · DOI 10.1002/mco2.70515
6. Promising Drugs Targeting Specific Mechanisms of Deregulation in T Cell Lineage Acute Lymphoblastic Leukemia.
   Thomas X. · · 2025 · cited 1× · PMID 40249557 · DOI 10.1007/s40487-025-00339-1
7. Unraveling the Genetic Heterogeneity of Acute Lymphoblastic Leukemia Based on NGS Applications.
   Ramírez Maldonado V, Navas Acosta J, Maldonado Marcos I, Villaverde Ramiro Á, et al · · 2024 · cited 1× · PMID 39682152 · DOI 10.3390/cancers16233965
8. Intensified pegylated-asparaginase in consolidation therapy improved outcome of allogeneic hematopoietic stem cell transplantation for adult T-cell acute lymphoblastic leukemia.
   Chen J, Li J, Wang Z, Huang Z, et al · · 2025 · PMID 41430506 · DOI 10.1007/s00277-025-06576-8