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

NCT ID: NCT03553238

Last Updated: 2018-06-12

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

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-14

Study Completion Date

2020-08-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Leukemia, Acute Leukemia, T Cell Leukemia, Lymphoblastic

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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ETP-ALL

Chidamide 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.

Group Type EXPERIMENTAL

Chidamide

Intervention Type DRUG

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

Dexamethasone

Intervention Type DRUG

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

vincristine

Intervention Type DRUG

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

Cyclophosphamide

Intervention Type DRUG

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

Idarubicin

Intervention Type DRUG

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

Pegaspargase

Intervention Type DRUG

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

Adriamycin

Intervention Type DRUG

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

Methotrexate

Intervention Type DRUG

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

6-Mercaptopurine

Intervention Type DRUG

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

Etoposide

Intervention Type DRUG

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

Cytarabine

Intervention Type DRUG

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

Bone marrow aspiration

Intervention Type PROCEDURE

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

Intrathecal injection

Intervention Type PROCEDURE

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

Radiation therapy

Intervention Type RADIATION

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

NGS

Intervention Type GENETIC

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

allogeneic hematopoietic stem cell transplantation

Intervention Type PROCEDURE

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

Flow-MRD

Intervention Type DIAGNOSTIC_TEST

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

FISH

Intervention Type DIAGNOSTIC_TEST

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

Flow immunophenotyping

Intervention Type DIAGNOSTIC_TEST

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

Karyotyping

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Chidamide

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

Intervention Type DRUG

Dexamethasone

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

Intervention Type DRUG

vincristine

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

Intervention Type DRUG

Cyclophosphamide

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

Intervention Type DRUG

Idarubicin

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

Intervention Type DRUG

Pegaspargase

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

Intervention Type DRUG

Adriamycin

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

Intervention Type DRUG

Methotrexate

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

Intervention Type DRUG

6-Mercaptopurine

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

Intervention Type DRUG

Etoposide

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

Intervention Type DRUG

Cytarabine

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

Intervention Type DRUG

Bone marrow aspiration

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

Intervention Type PROCEDURE

Intrathecal injection

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

Intervention Type PROCEDURE

Radiation therapy

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

Intervention Type RADIATION

NGS

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

Intervention Type GENETIC

allogeneic hematopoietic stem cell transplantation

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

Intervention Type PROCEDURE

Flow-MRD

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

Intervention Type DIAGNOSTIC_TEST

FISH

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

Intervention Type DIAGNOSTIC_TEST

Flow immunophenotyping

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

Intervention Type DIAGNOSTIC_TEST

Karyotyping

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

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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HDACi chidamide DXM VCR CTX IDA PEG-ASP ADR MTX 6-MP VP-16 AraC BM test IT RT allo-HSCT

Eligibility Criteria

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Inclusion Criteria

* 14-55 years old;
* ETP-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-ETP-ALL.
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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Hongsheng Zhou, MD, PhD

Role: STUDY_DIRECTOR

Nanfang Hospital, Southern Medical University, CHINA

Locations

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Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Hongsheng Zhou, MD, Ph.D

Role: CONTACT

[email protected]
+862062787349

Facility Contacts

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Hongsheng Zhou, MD, PhD

Role: primary

[email protected]
+862062787349

References

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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.

Reference Type BACKGROUND
PMID: 21740230 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27069254 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28605290 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23103132 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39468701 (View on PubMed)

Other Identifiers

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PDT-ETP-ALL

Identifier Type: -

Identifier Source: org_study_id

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