NCT02690922

Brief Summary

The aim of our study is to improve the major molecular remission(MMR) rate and reduce the cost to treat ph(+) Acute Lymphoblastic Leukemia (ALL) by adjusting chemotherapy regimens and the dosage of Tyrosine Kinase Inhibitor (TKI). lower the classification of chemotherapy drugs, lower the side effect brought by which this would be a grateful news for the patients once this regimens gain a successful result, which is also the final aim of our efforts.

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
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2016

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

First Submitted

Initial submission to the registry

January 27, 2016

Completed
28 days until next milestone

First Posted

Study publicly available on registry

February 24, 2016

Completed
6 days until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

February 24, 2016

Status Verified

February 1, 2016

Enrollment Period

10 months

First QC Date

January 27, 2016

Last Update Submit

February 23, 2016

Conditions

ph+ Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (1)

  • The rate of major molecular remission after two cycle chemotherapy with MTX and dasatinib

    115 days

Secondary Outcomes (1)

  • Time needed to achieve MMR

    30 days

Study Arms (1)

ph+ ALL with dasatinib

EXPERIMENTAL

patients in the arm are newly diagnosed ph+ ALL,the patient first receive dexamethasone as pretreatment,then dasatinib and prednisone are used as inductive treatment,and methotrexate to consolidate the therapy.

Drug: DasatinibDrug: prednisoneDrug: dexamethasoneDrug: methotrexate

Interventions

DasatinibDRUG

100mg (d1-d84)

Also known as: Sprycel
ph+ ALL with dasatinib
prednisoneDRUG

60mg/m2 d1-24

Also known as: Pred
ph+ ALL with dasatinib
dexamethasoneDRUG

10mg/d 3-7days

Also known as: Decadron
ph+ ALL with dasatinib
methotrexateDRUG

3g/m2 1day

Also known as: MTX
ph+ ALL with dasatinib

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Get signed the informed consent of patients and family members
  • Age ≥ 18 one full year of life
  • Confirm the ph + ALL at molecular biology level
  • Normal heart and lungs function
  • Normal liver and kidney function

You may not qualify if:

  • Leukemia in the nervous system
  • Recurrent patients
  • Allergies associated with any drug in our research
  • At the same time with other organs' malignant tumours
  • participating in other clinical researches at the same time

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tongji hospital

Wuhan, Hubei, 430000, China

Location

Related Publications (2)

  • Fujisawa S, Nakamae H, Ogura M, Ishizawa K, Taniwaki M, Utsunomiya A, Matsue K, Takamatsu Y, Usuki K, Tanimoto M, Ishida Y, Akiyama H, Onishi S. Efficacy and safety of dasatinib versus imatinib in Japanese patients with newly diagnosed chronic-phase chronic myeloid leukemia (CML-CP): Subset analysis of the DASISION trial with 2-year follow-up. Int J Hematol. 2014 Feb;99(2):141-53. doi: 10.1007/s12185-013-1470-1. Epub 2013 Dec 20.

    PMID: 24357015RESULT

  • Peng Y, Huang J, Yin J, Meng F, Cao Y, Huang L, Li D, Zhang Y, Zhang D, Meng L, Han Z, Hong Z. Frontline combination of dasatinib and low-intensity chemotherapy in adults with de novo Philadelphia chromosome-positive acute lymphoblastic leukemia. Expert Rev Hematol. 2024 Apr-May;17(4-5):173-180. doi: 10.1080/17474086.2024.2343885. Epub 2024 Apr 24.

    PMID: 38616308DERIVED

MeSH Terms

Interventions

DasatinibPrednisoneprednylideneDexamethasoneCalcium DobesilateMethotrexate

Intervention Hierarchy (Ancestors)

ThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidinesPregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsPregnadienetriolsSteroids, FluorinatedBenzenesulfonatesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsArylsulfonatesArylsulfonic AcidsSulfonic AcidsSulfur AcidsAminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Li Meng, professor

    Tongji Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

January 27, 2016

First Posted

February 24, 2016

Study Start

March 1, 2016

Primary Completion

January 1, 2017

Study Completion

May 1, 2017

Last Updated

February 24, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)