Precision Diagnosis Directing HDACi Chidamide Target Therapy for Adult ETP-ALL
An Open-Label, One-Arm, Multi-Site Trial of Precision Diagnosis Directing Histone Deacetylase Inhibitor Chidamide Target Total Therapy for Adult Early T-cell Progenitor Acute Lymphoblastic Leukemia/Lymphoma
1 other identifier
interventional
70
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Feb 2016
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 14, 2016
CompletedFirst Submitted
Initial submission to the registry
April 21, 2018
CompletedFirst Posted
Study publicly available on registry
June 12, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2020
CompletedJune 12, 2018
June 1, 2018
4.3 years
April 21, 2018
June 11, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Event free survival
3 years
Secondary Outcomes (7)
Minimum residual disease after induction
3 months
CR after Induction Therapy
3 years
Death in induction
3 month
Adverse events
3 years
Relapse
3 years
- +2 more secondary outcomes
Study Arms (1)
ETP-ALL
EXPERIMENTALChidamide 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.
Interventions
Chidamide will be administrated at a dose of 10mg/day in PDT-ETP-ALL protocol.
Dexamethasone will be added in Pre-phase Regimen, Induction-Regimen, Consolidation-Module of PDT-ETP-ALL protocol.
Vincristine will be added to Induction-Regimen, Consolidation-Module and Maintenance-Module of PDT-ETP-ALL protocol.
CTX will be added to Induction-Regimen, Consolidation-Module and Maintenance-Module of PDT-ETP-ALL protocol.
IDA will be added to Induction-Regimen and Consolidation-Module of PDT-ETP-ALL protocol.
PEG-ASP will be added to Induction-Regimen and Consolidation-Module of PDT-ETP-ALL protocol.
Adriamycin will be added to Consolidation-Module of PDT-ETP-ALL protocol.
Methotrexate will be added to consolidation module of PDT-ETP-ALL protocol.
Mercaptopurine will be added to Consolidation-Module and Maintenance-Module of PDT-ETP-ALL protocol.
VP-16 will be added to Consolidation-Module of PDT-ETP-ALL protocol.
AraC will be added to Consolidation-Module of PDT-ETP-ALL protocol.
Bone marrow aspiration and additional tests will be performed in all module of PDT-ETP-ALL protocol.
Intrathecal injection chemotherapy will be performed in PDT-ETP-ALL protocol.
Radiation therapy will be performed for mediastinum and/or central nervous system leukemia in PDT-ETP-ALL protocol.
Allo-HSCT will be performed for patients with available donor in PDT-ETP-ALL protocol.
Flow-MRD will be added to PDT-ETP-ALL for bone marrow and cerebrospinal fluid samples.
Flow immunophenotyping will be performed in PDT-ETP-ALL protocol.
Eligibility Criteria
You may qualify if:
- years old;
- ETP-ALL newly diagnosed;
- signed written informed consent
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515, China
Related Publications (5)
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.
PMID: 21740230BACKGROUNDArber 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.
PMID: 27069254BACKGROUNDBond 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.
PMID: 28605290BACKGROUNDYu 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.
PMID: 23103132BACKGROUNDLin 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.
PMID: 39468701DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Hongsheng Zhou, MD, PhD
Nanfang Hospital, Southern Medical University, CHINA
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D., Professor
Study Record Dates
First Submitted
April 21, 2018
First Posted
June 12, 2018
Study Start
February 14, 2016
Primary Completion
May 30, 2020
Study Completion
August 30, 2020
Last Updated
June 12, 2018
Record last verified: 2018-06