NCT03553238

Precision Diagnosis Directing HDACi Chidamide Target Therapy for Adult ETP-ALL

Status unknown Phase 2, PHASE3 Last updated 12 June 2018

What this trial tests

Phase 2, PHASE3 trial testing Chidamide in Leukemia, Acute in 70 participants. Status unknown.

Timeline

14 February 2016

Primary endpoint
30 May 2020

30 August 2020

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	70
Start date	14 February 2016
Primary completion	30 May 2020
Estimated completion	30 August 2020
Sites	1 location across China

Drugs / interventions tested

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

Conditions studied

• Leukemia, Acute — all drugs for Leukemia, Acute →
• Leukemia, T Cell — all drugs for Leukemia, T Cell →
• Leukemia, Lymphoblastic — all drugs for Leukemia, Lymphoblastic →

Sponsor

Nanfang Hospital, Southern Medical University

Who can join

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

Sponsor's own description

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.

Publications & conference data

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

1. Novel targeted therapies of T cell lymphomas.
   Iżykowska K, Rassek K, Korsak D, Przybylski GK, et al · · 2020 · cited 49× · PMID 33384022 · DOI 10.1186/s13045-020-01006-w
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. Inside the biology of early T-cell precursor acute lymphoblastic leukemia: the perfect trick.
   Tarantini F, Cumbo C, Anelli L, Zagaria A, et al · · 2021 · cited 8× · PMID 34930475 · DOI 10.1186/s40364-021-00347-z
4. The Clinical Characteristics and Prognosis of AYA and Older Adult ETP-ALL/LBL: A Real-World Multicenter Study in China.
   Xiao J, Cai Z, Wang H, Li X, et al · · 2022 · cited 7× · PMID 35734596 · DOI 10.3389/fonc.2022.846573
5. Tucidinostat plus pediatric-inspired chemotherapy for newly diagnosed adult ETP-ALL/LBL: a single-arm, phase 2 trial.
   Lin J, Huang Z, Cai Z, Li J, et al · · 2024 · cited 4× · PMID 39468701 · DOI 10.1186/s13045-024-01624-8
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. How histone modifications influence cellular radiosensitivity: Pharmaceutically targeting epigenetic regulators as a promising avenue to overcome radioresistance.
   Song J, Ye L, Ding WQ, Qiao H, et al · · 2025 · PMID 41477347 · DOI 10.1016/j.apsb.2025.09.019
8. Current treatment strategies targeting histone deacetylase inhibitors in acute lymphocytic leukemia: a systematic review
   Zhang Y, Zhang G, Wang Y, Ye L, et al · · 2024