NCT03564470

Brief Summary

Ph-like 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, two-arm, multi-site trial PDT-Ph-like-ALL is aimed to evaluate the safety and effect of oral histone deacetylase inhibitor chidamide and dasatinib for adult Ph-like ALL.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P75+ for phase_2 leukemia

Timeline
Completed

Started Feb 2016

Typical duration for phase_2 leukemia

Geographic Reach
1 country

1 active site

Status
unknown

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

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

June 9, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 20, 2018

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2023

Completed
Last Updated

July 1, 2022

Status Verified

June 1, 2022

Enrollment Period

7.5 years

First QC Date

June 9, 2018

Last Update Submit

June 28, 2022

Conditions

LeukemiaLeukemia, AcuteLeukemia, LymphoblasticLeukemia, B-cell

Keywords

Acute Lymphoblastic LeukemiaPh-likeTyrosine Kinase InhibitorHistone Deacetylase Inhibitor

Outcome Measures

Primary Outcomes (1)

  • Event free survival

    EFS of Ph-like ALL group

    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 (2)

Chidamide

EXPERIMENTAL

Chidamide will be added to chidamide arm Ph-like ALL(CRLF2 high-expression, CRLF2/EPO/JAK2 rearrangement, JAK/IL-7R/SH2B3 mutation, etc).

Drug: Chidamide

Dasatinib

EXPERIMENTAL

Dasatinib at a dose of 100mg/day will be added to Dasatinib arm of Ph-like ALL (CRKL high-expression, ABL1 or ABL2 or CSFR1 or PRGFRB rearrangement, etc).

Drug: Dasatinib

Interventions

ChidamideDRUG

Chidamide will be administrated at dose of 10mg/day in chidamide arm in PDT-Ph-Like protocol. PDT-Ph-Like protocol for chidamide arm consists of diagnostic test (bone marrow aspiration, flow immunophenotyping, karyotyping，FISH, NGS, Flow-MRD), induction regimen (chidamide, prednisone, vincristine, cyclophosphamide, idarubicin, pegaspargase), consolidation regimen (chidamide, cytarabine, methotrexate, dexamethasone, cyclophosphamide, etoposide, 6-mercaptopurine, pegaspargase), MRD assessment and maintenance regimen, intrathecal injection chemotherapy, radiation therapy for CNS-involved leukemia and allogeneic hematopoietic stem cell transplantation.

Also known as: HDACi chidamide
Chidamide
DasatinibDRUG

Dasatinib will be administrated at a dose of 100mg/day in dasatinib arm in PDT-Ph-Like protocol. PDT-Ph-Like protocol for dasatinib arm consists of diagnostic test (bone marrow aspiration, flow immunophenotyping, karyotyping，FISH, NGS, Flow-MRD), induction regimen (dasatinib, prednisone, vincristine, cyclophosphamide, idarubicin, pegaspargase), consolidation regimen (dasatinib, cytarabine, methotrexate, dexamethasone, cyclophosphamide, etoposide, 6-mercaptopurine, pegaspargase), MRD assessment and maintenance regimen, intrathecal injection chemotherapy, radiation therapy for CNS-involved leukemia and allogeneic hematopoietic stem cell transplantation.

Also known as: TKI dasatinib
Dasatinib

Eligibility Criteria

Age14 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • years old;
  • Ph-like 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-Ph-like-ALL.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Hematology, Nanfang Hospital

Guangzhou, Guangdong, 510515, China

RECRUITING

MeSH Terms

Conditions

LeukemiaPrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, B-Cell

Interventions

N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamideDasatinib

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

ThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidines

Central Study Contacts

Hongshengq Zhou, MD, Ph.D

CONTACT

86-20-62787349zhs1@i.smu.edu.cn

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., Professor

Study Record Dates

First Submitted

June 9, 2018

First Posted

June 20, 2018

Study Start

February 14, 2016

Primary Completion

August 30, 2023

Study Completion

August 30, 2023

Last Updated

July 1, 2022

Record last verified: 2022-06

Locations

CN(1)