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

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.

Conditions

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

Interventions

DRUG

Chidamide

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

DRUG

Dexamethasone

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

DRUG

vincristine

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

DRUG

Cyclophosphamide

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

DRUG

Idarubicin

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

DRUG

Pegaspargase

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

DRUG

Adriamycin

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

DRUG

Methotrexate

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

DRUG

6-Mercaptopurine

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

DRUG

Etoposide

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

DRUG

Cytarabine

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

PROCEDURE

Bone marrow aspiration

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

PROCEDURE

Intrathecal injection

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

RADIATION

Radiation therapy

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

GENETIC

NGS

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

PROCEDURE

allogeneic hematopoietic stem cell transplantation

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

DIAGNOSTIC_TEST

Flow-MRD

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

DIAGNOSTIC_TEST

FISH

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

DIAGNOSTIC_TEST

Flow immunophenotyping

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

DIAGNOSTIC_TEST

Karyotyping

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

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University

  lead OTHER

Principal Investigators

• Hongsheng Zhou, MD, PhD · Nanfang Hospital, Southern Medical University, CHINA

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

14 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-02-14

Primary Completion

2020-05-30

Completion

2020-08-30

Countries

• China

Study Locations