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Leukemia, AcutePhase 2/3NCT03553238

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

A Phase 2/3 study testing Chidamide, Dexamethasone and vincristine in people with Leukemia, Acute and Leukemia, T Cell, run by Nanfang Hospital, Southern Medical University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 14 to 55 years
What is being tested?
Chidamide, Dexamethasone and vincristine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteChina
Study dates
14 Feb 2016to 30 Aug 2020
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 to 55 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Hongsheng Zhou, MD, Ph.D contact

+862062787349

zhs1@i.smu.edu.cn

China1 site, 1 recruiting

  • Nanfang Hospital, Southern Medical University

    Guangzhou, Guangdong, 510515

    Hongsheng Zhou, MD, PhD, +862062787349, zhs1@i.smu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: 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

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.

Keywords
Early T-cell Precursor, Acute Lymphoblastic Leukemia, Histone Deacetylase Inhibitor, Chidamide
Medical subject headings
Leukemia, Leukemia, T-Cell, Precursor Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ChidamideDrug

    Also called HDACi chidamide

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

  • DexamethasoneDrug

    Also called DXM

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

  • vincristineDrug

    Also called VCR

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

  • CyclophosphamideDrug

    Also called CTX

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

  • IdarubicinDrug

    Also called IDA

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

  • PegaspargaseDrug

    Also called PEG-ASP

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

  • AdriamycinDrug

    Also called ADR

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

  • MethotrexateDrug

    Also called MTX

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

  • 6-MercaptopurineDrug

    Also called 6-MP

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

  • EtoposideDrug

    Also called VP-16

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

  • CytarabineDrug

    Also called AraC

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

  • Bone marrow aspirationProcedure or surgery

    Also called BM test

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

  • Intrathecal injectionProcedure or surgery

    Also called IT

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

  • Radiation therapyRadiation

    Also called RT

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

  • NGSGenetic

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

  • allogeneic hematopoietic stem cell transplantationProcedure or surgery

    Also called allo-HSCT

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

  • Flow-MRDDiagnostic test

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

  • FISHDiagnostic test

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

  • Flow immunophenotypingDiagnostic test

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

  • KaryotypingDiagnostic test

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

Study groups in NCT03553238
Study groupRoleWhat they receive
ETP-ALLExperimentalChidamide 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.
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Event free survival

    Measured: 3 years

Secondary outcomes (7)

  1. Minimum residual disease after induction

    Measured: 3 months

  2. CR after Induction Therapy

    Measured: 3 years

  3. Death in induction

    Measured: 3 month

  4. Adverse events

    Measured: 3 years

  5. Relapse

    Measured: 3 years

  6. Relapse free survival

    Measured: 3 years

  7. Overall survival

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2018
  2. Study start14 Feb 2016
  3. Primary completion30 May 2020 (estimated)
  4. Study completion30 Aug 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03553238
Sponsor's protocol ID
PDT-ETP-ALL
Status last verified
Jun 2018
First submitted
21 Apr 2018
Last updated
12 Jun 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Chidamide, Dexamethasone and vincristine in people with Leukemia, Acute and Leukemia, T Cell, run by Nanfang Hospital, Southern Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Hongsheng Zhou, MD, Ph.D (+862062787349, zhs1@i.smu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Event free survival (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03553238, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2018; AzTrials last refreshed its copy on 8 Nov 2026.

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