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

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. 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.

Conditions

• Leukemia
• Leukemia, Acute
• Adult Lymphoblastic Lymphoma
• Leukemia, Lymphoblastic
• Leukemia, T Cell
• Adult Acute Lymphoblastic Leukemia
• Lymphoblastic Lymphoma
• Lymphoblastic Leukemia

Interventions

DRUG

Dexamethasone

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

DRUG

vincristine

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

DRUG

Cyclophosphamide

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

DRUG

Idarubicin

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

DRUG

Pegaspargase

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

DRUG

Adriamycin

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

DRUG

Methotrexate

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

DRUG

6-mercaptopurine.

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

DRUG

Etoposide

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

DRUG

Cytarabine

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

PROCEDURE

Bone marrow aspiration

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

PROCEDURE

Intrathecal injection

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

RADIATION

Radiation therapy

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

GENETIC

NGS

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

PROCEDURE

allogeneic hematopoietic stem cell transplantation

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

DIAGNOSTIC_TEST

Flow-MRD

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

DIAGNOSTIC_TEST

FISH

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

DIAGNOSTIC_TEST

Flow immunophenotyping

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

DIAGNOSTIC_TEST

Karyotyping

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

DRUG

Chidamide

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

DIAGNOSTIC_TEST

PET-CT scan

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

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University

  lead OTHER

Principal Investigators

• Qifa Liu, MD · Department of Hematology Nanfang Hospital

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

2021-05-30

Completion

2021-05-30

Countries

• China

Study Locations