NCT03515018

Brief Summary

RATIONALE: Drugs used in chronic-phase chronic myelogenous leukemia (CML) aimed to avoid CML conversion (AP, BC). Hydroxyurea pulse therapy for chronic-phase CML patients is effective based on the investigator's previous studies, and the scheme cost lower than imatinib. It is not yet known the efficacy compared Hydroxyurea pulse therapy with imatinib for chronic-phase CML, especially to achieve hematological remission in short time. PURPOSE: Non-randomized trial to compare the effectiveness of hydroxyurea pulse therapy with that of imatinib in treating chronic-phase CML patients.

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
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2018

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

April 16, 2018

Completed
15 days until next milestone

Study Start

First participant enrolled

May 1, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 3, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

May 22, 2018

Status Verified

December 1, 2017

Enrollment Period

2 years

First QC Date

April 16, 2018

Last Update Submit

May 21, 2018

Conditions

Leukemia, Chronic Myeloid

Keywords

Leukemia, Myeloid, Chronic-PhasehydroxyureaImatinib MesylatePulse Therapy, Drug

Outcome Measures

Primary Outcomes (1)

  • white blood cell count

    white blood cell count decreased by 10%, 20%, 30%, 50%

    2 years

Secondary Outcomes (3)

  • spleen size

    2 years

  • complete remission

    2 years

  • long-term efficacy: OS, EFS, PFS

    5 years

Study Arms (2)

Hydroxyurea

EXPERIMENTAL

Drug: hydroxyurea, pulse therapy

Drug: hydroxyurea

imatinib

ACTIVE COMPARATOR

Drug: imatinib, 400mg PO per day

Drug: Imatinib

Interventions

hydroxyureaDRUG

pulse therapy

Also known as: HU
Hydroxyurea
ImatinibDRUG

400mg qd PO per day

Also known as: Imatinib Mesylate
imatinib

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of Chronic Myelogenous Leukemia (CML) in chronic phase. Patients in either accelerated or blastic phases are not eligible.
  • No previous therapy with any drugs.
  • Age ≥ 16 years
  • Patients with uncontrolled tachyarrhythmias (such as, atrial fibrillation, paroxysmal supraventricular tachycardia, and ventricular tachycardias not adequately controlled) are not eligible.
  • Non-pregnant and non-nursing. Treatment under this protocol would expose an unborn child to significant risks. Women and men of reproductive potential should agree to use an effective means of birth control.

You may not qualify if:

  • Patients treated with any chemotherapy drugs.
  • Patients younger than 16 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the First Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150001, China

RECRUITING

Related Publications (2)

  • Valent P, Herndlhofer S, Schneeweiss M, Boidol B, Ringler A, Kubicek S, Gleixner KV, Hoermann G, Hadzijusufovic E, Mullauer L, Sperr WR, Superti-Furga G, Mannhalter C. TKI rotation-induced persistent deep molecular response in multi-resistant blast crisis of Ph+ CML. Oncotarget. 2017 Apr 4;8(14):23061-23072. doi: 10.18632/oncotarget.15481.

    PMID: 28416739BACKGROUND

  • Huang J, Wang L, Chen L, Qun H, Yajing X, Fangping C, Xielan Z. Changing Treatment May Affect the Predictive Ability of European Treatment Outcome Study Scoring for the Prognosis of Patients with Chronic Myeloid Leukemia. Turk J Haematol. 2017 Mar 1;34(1):10-15. doi: 10.4274/tjh.2016.0156. Epub 2016 Oct 18.

    PMID: 27751981BACKGROUND

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemia, Myeloid, Chronic-Phase

Interventions

HydroxyureaImatinib Mesylate

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsMyeloproliferative DisordersBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

UreaAmidesOrganic ChemicalsBenzamidesBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidines

Study Officials

  • Jin Zhou, MD, PhD

    First Affiliated Hospital of Harbin Medical University

    STUDY CHAIR

Central Study Contacts

Jin Zhou, MD, PhD

CONTACT

008645185555951zhoujin1111@126.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2018

First Posted

May 3, 2018

Study Start

May 1, 2018

Primary Completion

May 1, 2020

Study Completion

May 1, 2020

Last Updated

May 22, 2018

Record last verified: 2017-12

Locations

CN(1)