Clinical trial · Interventional

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

NCT03564704CI-TRIAL-00033385unknownPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions (8)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Adult Acute Lymphoblastic Leukemia	Adult Acute Lymphoblastic Leukemia	ONTOLOGY_EXACT	0.98
Adult Lymphoblastic Lymphoma	Adult Lymphoblastic Lymphoma	ONTOLOGY_EXACT	0.98
Leukemia	Leukemia	ONTOLOGY_EXACT	0.90
Leukemia, Acute	Acute Leukemia	ONTOLOGY_EXACT	0.90
Leukemia, Lymphoblastic	Acute Lymphoblastic Leukemia	ALIAS	0.90
Leukemia, T Cell	Leukemia	ONTOLOGY_EXACT	0.85
Lymphoblastic Leukemia	Acute Lymphoblastic Leukemia	ALIAS	0.90
Lymphoblastic Lymphoma	Lymphoblastic Lymphoma	ONTOLOGY_EXACT	0.90

Interventions

Interventions (21)

Intervention	Type	Mapped drug	Match
6-mercaptopurine.	Drug	Mercaptopurine	ALIAS
Adriamycin	Drug	—	UNRESOLVED
allogeneic hematopoietic stem cell transplantation	Procedure	—	UNRESOLVED
Bone marrow aspiration	Procedure	—	UNRESOLVED
Chidamide	Drug	—	UNRESOLVED
Cyclophosphamide	Drug	Cyclophosphamide	ALIAS
Cytarabine	Drug	Cytarabine	ALIAS
Dexamethasone	Drug	Dexamethasone	ALIAS

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
PDT-ALL-LBL
description
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.
interventionNames
1. Drug: Dexamethasone
2. Drug: vincristine
3. Drug: Cyclophosphamide
4. Drug: Idarubicin
5. Drug: Pegaspargase
6. Drug: Adriamycin
7. Drug: Methotrexate
8. Drug: 6-mercaptopurine.
9. Drug: Etoposide
10. Drug: Cytarabine
11. Procedure: Bone marrow aspiration
12. Procedure: Intrathecal injection
13. Radiation: Radiation therapy
14. Genetic: NGS
15. Procedure: allogeneic hematopoietic stem cell transplantation

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 14 Years
Maximum age: 55 Years

Show eligibility criteria text

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.

References

Publications (0)

Data not yet available

No reference posted for this study.

Registry

Dates and enrollment

Start: Feb 14, 2016
Primary completion: May 30, 2021
Completion: May 30, 2021
First posted: Jun 21, 2018
Last update posted: Jun 21, 2018
Enrollment: 80 (estimated)
Lead sponsor: Nanfang Hospital, Southern Medical University OTHER

Data updated 22 days agoSource updated Jun 21, 2018source: clinicaltrials

Locations

Locations by country (1)

Country	Sites	Recruiting
China	1	1

Trial listing is informational. Eligibility is decided by the study team; contact information is on ClinicalTrials.gov.