Precision Diagnosis Directing HDACi Chidamide Target Therapy for Adult T-LBL/ALL
An Open-Label, One-Arm, Multi-Site Trial of Precision Diagnosis Directing Histone Deacetylase Inhibitor Chidamide Total Therapy for Adult T-lymphoblastic Lymphoma/Leukemia
1 other identifier
interventional
80
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 leukemia
Started Feb 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 14, 2016
CompletedFirst Submitted
Initial submission to the registry
June 11, 2018
CompletedFirst Posted
Study publicly available on registry
June 21, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2021
CompletedJune 21, 2018
June 1, 2018
5.3 years
June 11, 2018
June 11, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Event-Free-Survival
3 years EFS of LBL/ALL patients enrolled in PDT-ALL-LBL
3 years
Secondary Outcomes (7)
Minimum residual disease after induction
3 months
CR after Induction Therapy
3 months
Death in induction
3 months
Adverse events
3 years
Relapse
3 years
- +2 more secondary outcomes
Study Arms (1)
PDT-ALL-LBL
EXPERIMENTALThe 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.
Interventions
Dexamethasone will be added in Pre-phase Regimen, Induction-Regimen, Consolidation-Module of PDT-ALL-LBL protocol.
Vincristine will be added to Induction-Regimen, Consolidation-Module and Maintenance-Module of PDT-ALL-LBL protocol.
CTX will be added to Induction-Regimen, Consolidation-Module and Maintenance-Module of PDT-ALL-LBL protocol.
IDA will be added to Induction-Regimen and Consolidation-Module of PDT-ALL-LBL protocol.
PEG-ASP will be added to Induction-Regimen and Consolidation-Module of PDT-ALL-LBL protocol.
Adriamycin will be added to Consolidation-Module of PDT-ALL-LBL protocol.
Methotrexate will be added to Consolidation-Module of PDT-ALL-LBL protocol.
Mercaptopurine will be added to Consolidation-Module and Maintenance-Module of PDT-ALL-LBL protocol.
VP-16 will be added to Consolidation-Module of PDT-ALL-LBL protocol.
AraC will be added to Consolidation-Module of PDT-ALL-LBL protocol.
Bone marrow aspiration and additional tests will be performed in all module of PDT-ALL-LBL protocol.
Intrathecal injection of chemotherapy will be performed in PDT-ALL-LBL protocol.
Radiation therapy will be performed for mediastinum and/or central nervous system leukemia/lymphoma in PDT-ALL-LBL protocol.
Allo-HSCT will be added to LBL patients with available donor in PDT-ALL-LBL protocol.
Flow-MRD will be added to PDT-ALL-LBL for bone marrow and cerebrospinal fluid samples.
Flow immunophenotyping will be performed in PDT-ALL-LBL protocol.
HDACi chidamide will be added to induction regimen, consolidation and maintenance module of PDT-ALL-LBL.
PET-scan will be performed for T-LBL patients for MRD assessment in PDT-ALL-LBL.
Eligibility Criteria
You may qualify if:
- years old;
- LBL/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-ALL-LBL protocol.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Hematology, Nanfang Hospital
Guangzhou, Guangdong, 510515, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Qifa Liu, MD
Department of Hematology Nanfang Hospital
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
June 11, 2018
First Posted
June 21, 2018
Study Start
February 14, 2016
Primary Completion
May 30, 2021
Study Completion
May 30, 2021
Last Updated
June 21, 2018
Record last verified: 2018-06