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LeukemiaPhase 2/3NCT03564704

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

A Phase 2/3 study testing Dexamethasone, vincristine and Cyclophosphamide in people with Leukemia and Leukemia, Acute, 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 The sponsor has not verified this record for over two years, so it may be out of date.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

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. Read more about this study

Who is it for?
Ages 14 to 55 years
What is being tested?
Dexamethasone, vincristine and Cyclophosphamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteChina
Study dates
14 Feb 2016to 30 May 2021
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;
  • LBL/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-ALL-LBL protocol.

Trial locations and contacts

1 site in 1 country.

Hongsheng Zhou contact

+862062787349

zhs1@i.smu.edu.cn

China1 site, 1 recruiting

  • Department of Hematology, Nanfang Hospital

    Guangzhou, Guangdong, 510515

    Hongsheng Zhou, +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 Total Therapy for Adult T-lymphoblastic Lymphoma/Leukemia

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.

Read the detailed description

T-lymphoblastic lymphoma/leukemia is a neoplasm of lymphoblasts committed to the T-cell lineage, typically composed of small to medium-sized blast with scant cytoplasm, moderately condensed to dispersed chromatin, and inconspicuous nucleoli, involving bone marrow and blood or presenting with primary involvement of the thymus or of nodal or extranodal sites. T-ALL/LBL is generally considered a higher-risk disease than B-ALL. Compared to B-ALL, T-LBL/ALL is associated with a higher risk of induction failure, early relapse, and isolated CNS relapse.

Chidamide is a novel oral HDACi with promising activity in non-Hodgkin lymphoma (NHL). Chidamide, a new oral isotype-selective HDACi, approved in China for the treatment of R/R PTCL in December 2014. Based on the pediatric-inspired, PEG-L-asparaginase-intensified and MRD-directed PDT-ALL-2016 protocol, this open-label, two-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.

The intervention of PDT-ALL-LBL consists of diagnostic test (bone marrow aspiration, flow immunophenotyping, karyotyping，FISH, NGS, Flow-MRD), induction regimen (chidamide, dexamethasone, vincristine, cyclophosphamide, Idarubicin, pegaspargase), consolidation regimen (chidamide, prednisone, cytarabine, methotrexate, cyclophosphamide, etoposide, adriamycin, 6-mercaptopurine, pegaspargase), MRD assessment (MRD1/d14, MRD2/d24, MRD3/d45, MRD4/pre-allo-HSCT) and maintenance regimen (chidamide, vincristine, methotrexate, 6-mercaptopurine), intrathecal injection, radiation therapy (for mediastinum- and/or central nervous system-involved lymphoma/leukemia) and allogeneic hematopoietic stem cell transplantation for patients with donor.

Induction Regimen-Pretreatment: dexamethasone, -3d to 0d; Induction regimen VICLD: VCR: d1, d8, d15, d22; IDA: d1, d8; CTX: 1g/m2, 1; PEG-asp: 2000-2500IU/m2, 1, 15; dexamethasone: 1-24; chidamide: 10mg/d, po, qd. Flow-based MRD assessment: d14, d24 during induction regimen, d45, and pre-HSCT. Salvage regimen VLCAM (MRD1/d24>1%): CTX, d25; AraC 50mg/m2, d25-31; 6-MP: 25-31, PEG-asp: 2500IU/m2, d26. Consolidation Module (CM)-CM1: AraC 3g/m2, q12h, d1-2, Dex: 10mg/m2, d1-2, PEG-asp: 2, 6-MP: d1-7, chidamide, po qd; CM2: MTX 5g/m2, 1, Dex: 10mg/m2, 1-2, PEG-asp: d2, 6-MP: 1-7, chidamide, po qd; CM3: CTX 1g/m2, 1-3, PEG-asp: 2, 6-MP: 1-7, chidamide, po qd. CM4-6: repeat CM 1-3. Re-Induction: VICLD after CM6. CM7-9: repeat CM1-3. Allo-HSCT: after CM3 when matched-related-donor (MRD), haploidentical related donor (HRD) or matched-unrelated-donor (MUD) available. Non-allo-HSCT: finish CM4-9 and CPOMP maintenance. Maintenance Module-CPOMP: chidamide, po qd for 24 months; Pred: for 12 months; VCR for 12 months; MTX: for 24m months; 6-MP for 24 months.

Medical subject headings
Leukemia, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, T-Cell

What participants receive

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

  • DexamethasoneDrug

    Also called DXM

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

  • vincristineDrug

    Also called VCR

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

  • CyclophosphamideDrug

    Also called CTX

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

  • IdarubicinDrug

    Also called IDA

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

  • PegaspargaseDrug

    Also called PEG-ASP

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

  • AdriamycinDrug

    Also called ADR

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

  • MethotrexateDrug

    Also called MTX

    Methotrexate will be added to Consolidation-Module of PDT-ALL-LBL protocol.

  • 6-mercaptopurine.Drug

    Also called 6-MP

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

  • EtoposideDrug

    Also called VP-16

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

  • CytarabineDrug

    Also called AraC

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

  • Bone marrow aspirationProcedure or surgery

    Also called BM smear

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

  • Intrathecal injectionProcedure or surgery

    Also called IT

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

  • Radiation therapyRadiation

    Also called RT

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

  • NGSGenetic

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

  • allogeneic hematopoietic stem cell transplantationProcedure or surgery

    Also called Allo-HSCT

    Allo-HSCT will be added to LBL patients with available donor in PDT-ALL-LBL protocol.

  • Flow-MRDDiagnostic test

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

  • FISHDiagnostic test

    FISH will be added to PDT-ALL-LBL for bone marrow samples.

  • Flow immunophenotypingDiagnostic test

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

  • KaryotypingDiagnostic test

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

  • ChidamideDrug

    Also called HDACi Chidamide

    HDACi chidamide will be added to induction regimen, consolidation and maintenance module of PDT-ALL-LBL.

  • PET-CT scanDiagnostic test

    Also called PET-CT

    PET-scan will be performed for T-LBL patients for MRD assessment in PDT-ALL-LBL.

Study groups in NCT03564704
Study groupRoleWhat they receive
PDT-ALL-LBLExperimentalThe intervention of PDT-ALL-LBL 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 (methotrexate, cytarabine, dexamethasone), radiation therapy (for mediastinum- and/or central nervous system-involved lymphoma/leukemia) and allogeneic hematopoietic stem cell transplantation for patients with donor.
Receives: 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; Drug: Chidamide; Diagnostic Test: PET-CT scan

What is being measured

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

  1. Event-Free-Survival

    3 years EFS of LBL/ALL patients enrolled in PDT-ALL-LBL

    Measured: 3 years

Secondary outcomes (7)

  1. Minimum residual disease after induction

    MRD after induction regimen of PDT-ALL-LBL protocol

    Measured: 3 months

  2. CR after Induction Therapy

    CR after induction regimen of PDT-ALL-LBL protocol

    Measured: 3 months

  3. Death in induction

    Dearth during induction regimen of PDT-ALL-LBL

    Measured: 3 months

  4. Adverse events

    AE of 3 years of LBL patients enrolled in PDT-ALL-LBL

    Measured: 3 years

  5. Relapse

    Cumulative incidence relapse rate of 3 years of LBL patients enrolled in PDT-ALL-LBL protocol

    Measured: 3 years

  6. Relapse free survival

    3 years RFS of LBL patients enrolled in PDT-ALL-LBL protocol

    Measured: 3 years

  7. Overall survival

    3 years OS of LBL patients enrolled in PDT-ALL-LBL protocol

    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 posted21 Jun 2018
  2. Study start14 Feb 2016
  3. Primary completion30 May 2021 (estimated)
  4. Study completion30 May 2021 (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
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03564704
Sponsor's protocol ID
PDT-ALL-LBL
Status last verified
Jun 2018
First submitted
11 Jun 2018
Last updated
21 Jun 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Dexamethasone, vincristine and Cyclophosphamide in people with Leukemia and Leukemia, Acute, 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 21 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 (+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 NCT03564704.

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 21 Jun 2018.

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