NCT02511340

Brief Summary

Multi-center, single stage, phase II study to evaluate the efficacy and safety of Flumatinib in accelerated or blastic Phase chronic myelogenous leukemia 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
167

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2013

Typical duration for phase_2

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

January 1, 2013

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

July 26, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 30, 2015

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

July 30, 2015

Status Verified

July 1, 2015

Enrollment Period

2.6 years

First QC Date

July 26, 2015

Last Update Submit

July 29, 2015

Conditions

Chronic Myelogenous Leukemia

Outcome Measures

Primary Outcomes (1)

  • Confirmed overall hematologic response（OHR）at 6 months

    6 months

Study Arms (1)

Flumatinib mesylate tablet 600 mg qd

EXPERIMENTAL

Flumatinib, 600mg, qd

Drug: Flumatinib mesylate tablet 600 mg qd

Interventions

Flumatinib mesylate tablet 600 mg qdDRUG

Flumatinib mesylate tablet 600 mg qd in CML-AP or CML-BP patients

Flumatinib mesylate tablet 600 mg qd

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female patients age 18-75 year-old;
  • ECOG 0 - 2;
  • Newly diagnosed or previously treated Ph+ CML patients in accelerated or blastic Phase;
  • Adequate organ function;
  • Written informed consent prior to any study procedures being performed.

You may not qualify if:

  • Patients in Chronic and Blastic Phases;
  • Previously treated with Flumatinib;
  • Previously documented T315I mutations;
  • Previous therapy within protocol defined timeframe, including:
  • hydroxyurea within 24 hr,
  • Imatinib or Nilotinib or Dasatinib within 28 days)
  • Cardiac dysfunction ;
  • History of congenital or acquired bleeding disorders unrelated to CML;
  • Central nervous system leukemia;
  • Previous malignancy except CML;
  • Acute or chronic liver or severe kidney disease unrelated to CML;
  • Pregnant, breastfeeding, child bearing potential but failed to take effective contraception.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Union Hospital Tongji Medical College Huazhong University of Science and technology

Wuhan, Hubei, 430022, China

Location

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Condition Hierarchy (Ancestors)

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

Study Officials

  • Kaiyan Liu

    Peking University People's Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2015

First Posted

July 30, 2015

Study Start

January 1, 2013

Primary Completion

August 1, 2015

Study Completion

December 1, 2015

Last Updated

July 30, 2015

Record last verified: 2015-07

Locations

CN(1)