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

NCT ID: NCT03564704

Last Updated: 2018-06-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-14

Study Completion Date

2021-05-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PDT-ALL-LBL

The 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.

Group Type EXPERIMENTAL

Dexamethasone

Intervention Type DRUG

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

vincristine

Intervention Type DRUG

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

Cyclophosphamide

Intervention Type DRUG

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

Idarubicin

Intervention Type DRUG

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

Pegaspargase

Intervention Type DRUG

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

Adriamycin

Intervention Type DRUG

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

Methotrexate

Intervention Type DRUG

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

6-mercaptopurine.

Intervention Type DRUG

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

Etoposide

Intervention Type DRUG

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

Cytarabine

Intervention Type DRUG

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

Bone marrow aspiration

Intervention Type PROCEDURE

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

Intrathecal injection

Intervention Type PROCEDURE

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

Radiation therapy

Intervention Type RADIATION

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

NGS

Intervention Type GENETIC

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

allogeneic hematopoietic stem cell transplantation

Intervention Type PROCEDURE

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

Flow-MRD

Intervention Type DIAGNOSTIC_TEST

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

FISH

Intervention Type DIAGNOSTIC_TEST

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

Flow immunophenotyping

Intervention Type DIAGNOSTIC_TEST

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

Karyotyping

Intervention Type DIAGNOSTIC_TEST

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

Chidamide

Intervention Type DRUG

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

PET-CT scan

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Dexamethasone

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

Intervention Type DRUG

vincristine

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

Intervention Type DRUG

Cyclophosphamide

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

Intervention Type DRUG

Idarubicin

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

Intervention Type DRUG

Pegaspargase

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

Intervention Type DRUG

Adriamycin

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

Intervention Type DRUG

Methotrexate

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

Intervention Type DRUG

6-mercaptopurine.

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

Intervention Type DRUG

Etoposide

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

Intervention Type DRUG

Cytarabine

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

Intervention Type DRUG

Bone marrow aspiration

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

Intervention Type PROCEDURE

Intrathecal injection

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

Intervention Type PROCEDURE

Radiation therapy

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

Intervention Type RADIATION

NGS

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

Intervention Type GENETIC

allogeneic hematopoietic stem cell transplantation

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

Intervention Type PROCEDURE

Flow-MRD

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

Intervention Type DIAGNOSTIC_TEST

FISH

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

Intervention Type DIAGNOSTIC_TEST

Flow immunophenotyping

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

Intervention Type DIAGNOSTIC_TEST

Karyotyping

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

Intervention Type DIAGNOSTIC_TEST

Chidamide

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

Intervention Type DRUG

PET-CT scan

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

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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DXM VCR CTX IDA PEG-ASP ADR MTX 6-MP VP-16 AraC BM smear IT RT Allo-HSCT HDACi Chidamide PET-CT

Eligibility Criteria

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Inclusion Criteria

* 14-55 years old;
* LBL/ALL newly diagnosed;
* signed written informed consent.

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-ALL-LBL protocol.
Minimum Eligible Age

14 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role lead

Responsible Party

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Qifa Liu

M.D., Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Qifa Liu, MD

Role: STUDY_CHAIR

Department of Hematology Nanfang Hospital

Locations

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Department of Hematology, Nanfang Hospital

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Hongsheng Zhou

Role: CONTACT

[email protected]
+862062787349

Facility Contacts

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Hongsheng Zhou

Role: primary

[email protected]
+862062787349

Other Identifiers

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PDT-ALL-LBL

Identifier Type: -

Identifier Source: org_study_id

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