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Status unknownNCT03553238Updated Jun 12, 2018

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

A Phase 2/3 interventional study of Chidamide and Dexamethasone in Leukemia, Acute, Leukemia, T Cell and Leukemia, Lymphoblastic, sponsored by Nanfang Hospital, Southern Medical University. Status unknown at 1 site in China. Open to participants aged 14 Years to 55 Years. Per ClinicalTrials.gov, last updated 2018-06-12.

Sponsored by Nanfang Hospital, Southern Medical University · Phase 2/3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2018), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 2 years 2 months after the study started (first participant enrolled Feb 2016, registered Apr 2018).
Phase
Phase 2/3
Study type
Interventional
Enrollment
70
Allocation
Not applicable
Ages
14 Years to 55 Years
Sex
All
01

Study summary

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.

Read the detailed description

Early T-cell precursor (ETP) lymphoblastic leukemia (ETP-ALL) is a neoplasm composed of cells committed to the T-cell lineage but with an unique immunophenotype indicating only limited early T differentiation. In the highly orchestrated development of T cell fate specification under physiological condition, the most immature early thymic progenitors (ETPs) retain multilineage potentials. ETP-ALL blasts have a characteristic immunophenotype, with reduced/absent expression of T-lymphoid markers CD1a, CD5, CD8; and positivity for at least one HSC and/or myeloid antigen CD34, CD117, HLA-DR, CD13, CD33, CD11b, CD65. Recent study shed light on the genetic landscape of adult ETP-ALL, which revealed that more than 40% adult ETP-ALL harbored histone modification mutations. Chidamide is a novel oral HDACi with promising activity in non-Hodgkin lymphoma (NHL). 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. HDACi chidamide at a dose of 10mg/day will be added to ETP-ALL group from induction therapy to consolidation therapy (total courses of chidamide treatment: 5 courses for allo-HSCT after Consolidation Module-3; 12 courses for patients non-allo-HSCT after Consolidation Module 1-9). Primary study endpoint of PDT-ETP-ALL is event-free survival of ETP-ALL group and secondary study endpoints are complete remission and MRD after induction, adverse event and overall survival of ETP-ALL group.

Pretreatment: Dexamethasone, -3 to 0d;

Induction:VCR: 1, 8, 15, 22; IDA: 1, 8; CTX: 1g/m2, 1, 8; PEG-asp: 2000-2500IU/m2, 1, 15; Dex: 1-24, chidamide: 10mg/d, po, qd.

MRD: d14, 24, 45, and pre-allo-HSCT.

VLCAM (MRD1/d14>1%): CTX, d25; AraC 2g/m2, q12h, d25, 26; 6-MP: 25-31, PEG-asp: 26; chidamide: 10mg/d, po, qd.

Consolidation Module:

CM-1: AraC 3g/m2, q12h, 1-2, Dex: 10mg/m2, 1-2, PEG-asp: 2, 6-MP: 1-7. IT: d1, chidamide: 10mg/d, po, qd.

CM-2: MTX 5g/m2, 1, Dex: 10mg/m2, 1-2, PEG-asp: 2; 6-MP: 1-7; IT: d1; chidamide: 10mg/d, po, qd.

CM-3: CTX 0.5g/m2, 1-3, PEG-asp: 2, Doxorubicin: 40mg/m2, 4, 6-MP: 1-7, IT: d1;chidamide: 10mg/d, po, qd.

Allo-HSCT: after CM-3 when donors available. Non-HSCT: finish CM 4-9 and POMP maintenance.

CM 4-6: repeat CM 1-3. Re-Induction: after CM-6. CM 7-9: repeat CM1-3.

Maintenance: CPOMP-chidamide 10mg/d, po, qd; Pred for 12 months; VCR for 12 months; MTX for 24 months; 6-MP for 24 months.

02

Conditions studied

  • Leukemia, Acute
  • Leukemia, T Cell
  • Leukemia, Lymphoblastic

Keywords

  • Early T-cell Precursor
  • Acute Lymphoblastic Leukemia
  • Histone Deacetylase Inhibitor
  • Chidamide
03

In context

Leukemia

5,475 studies on the registry are indexed under Leukemia; 629 are open to participants now.

This study's planned enrollment of 70 is above the median of 38 across 4,268 interventional studies indexed under Leukemia.

Browse Leukemia studies →

Lead sponsor

Nanfang Hospital, Southern Medical University is the lead sponsor of 488 studies on the registry; 213 are open to participants now.

Browse Nanfang Hospital, Southern Medical University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
14 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 14-55 years old;
  • ETP-ALL newly diagnosed;
  • signed written informed consent

Exclusion criteria

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.
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
70 participants (estimated)

Study arms

  • Experimental
    ETP-ALL

    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.

    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 · Diagnostic Test: Flow-MRD · Diagnostic Test: FISH · Diagnostic Test: Flow immunophenotyping · Diagnostic Test: Karyotyping

Interventions

  • DrugChidamide

    Chidamide will be administrated at a dose of 10mg/day in PDT-ETP-ALL protocol.

    Also known as: HDACi chidamide

  • DrugDexamethasone

    Dexamethasone will be added in Pre-phase Regimen, Induction-Regimen, Consolidation-Module of PDT-ETP-ALL protocol.

    Also known as: DXM

  • Drugvincristine

    Vincristine will be added to Induction-Regimen, Consolidation-Module and Maintenance-Module of PDT-ETP-ALL protocol.

    Also known as: VCR

  • DrugCyclophosphamide

    CTX will be added to Induction-Regimen, Consolidation-Module and Maintenance-Module of PDT-ETP-ALL protocol.

    Also known as: CTX

  • DrugIdarubicin

    IDA will be added to Induction-Regimen and Consolidation-Module of PDT-ETP-ALL protocol.

    Also known as: IDA

  • DrugPegaspargase

    PEG-ASP will be added to Induction-Regimen and Consolidation-Module of PDT-ETP-ALL protocol.

    Also known as: PEG-ASP

  • DrugAdriamycin

    Adriamycin will be added to Consolidation-Module of PDT-ETP-ALL protocol.

    Also known as: ADR

  • DrugMethotrexate

    Methotrexate will be added to consolidation module of PDT-ETP-ALL protocol.

    Also known as: MTX

  • Drug6-Mercaptopurine

    Mercaptopurine will be added to Consolidation-Module and Maintenance-Module of PDT-ETP-ALL protocol.

    Also known as: 6-MP

  • DrugEtoposide

    VP-16 will be added to Consolidation-Module of PDT-ETP-ALL protocol.

    Also known as: VP-16

  • DrugCytarabine

    AraC will be added to Consolidation-Module of PDT-ETP-ALL protocol.

    Also known as: AraC

  • ProcedureBone marrow aspiration

    Bone marrow aspiration and additional tests will be performed in all module of PDT-ETP-ALL protocol.

    Also known as: BM test

  • ProcedureIntrathecal injection

    Intrathecal injection chemotherapy will be performed in PDT-ETP-ALL protocol.

    Also known as: IT

  • RadiationRadiation therapy

    Radiation therapy will be performed for mediastinum and/or central nervous system leukemia in PDT-ETP-ALL protocol.

    Also known as: RT

  • GeneticNGS

    Next-Generation-Sequencing (NGS) will be performed in PDT-ETP-ALL protocol.

  • Procedureallogeneic hematopoietic stem cell transplantation

    Allo-HSCT will be performed for patients with available donor in PDT-ETP-ALL protocol.

    Also known as: allo-HSCT

  • Diagnostic testFlow-MRD

    Flow-MRD will be added to PDT-ETP-ALL for bone marrow and cerebrospinal fluid samples.

  • Diagnostic testFISH

    FISH will be performed in PDT-ETP-ALL for bone marrow samples.

  • Diagnostic testFlow immunophenotyping

    Flow immunophenotyping will be performed in PDT-ETP-ALL protocol.

  • Diagnostic testKaryotyping

    Karyotyping will be performed in PDT-ETP-ALL protocol.

06

What researchers measure

Primary outcomes

  1. Event free survival

    Time frame: 3 years

Secondary outcomes

  1. Minimum residual disease after induction

    Time frame: 3 months

  2. CR after Induction Therapy

    Time frame: 3 years

  3. Death in induction

    Time frame: 3 month

  4. Adverse events

    Time frame: 3 years

  5. Relapse

    Time frame: 3 years

  6. Relapse free survival

    Time frame: 3 years

  7. Overall survival

    Time frame: 3 years

07

Study locations

1 of 1 sites recruiting
  • Nanfang Hospital, Southern Medical University
    Guangzhou, Guangdong 510515, China
    Recruiting
08

References and documents

Publications

  • Koch 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. PubMed 21740230 ↗
  • Arber 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. PubMed 27069254 ↗
  • Bond 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. PubMed 28605290 ↗
  • Yu 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. PubMed 23103132 ↗
  • Lin 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. PubMed 39468701 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 12, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03553238
Lead sponsor
Nanfang Hospital, Southern Medical University
Responsible party
Qifa Liu (M.D., Professor, Nanfang Hospital, Southern Medical University) — Principal investigator
First posted
Jun 12, 2018
Start date
Feb 14, 2016
Primary completion
May 30, 2020 (estimated)
Completion
Aug 30, 2020 (estimated)
Last update
Jun 12, 2018

Study contacts

Hongsheng Zhou, MD, Ph.D
Contact
zhs1@i.smu.edu.cn
+862062787349
Hongsheng Zhou, MD, PhD
study director · Nanfang Hospital, Southern Medical University, CHINA

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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