NCT01464047

Brief Summary

The purpose of this post-marketing surveillance is to investigate and confirm the type and incidence of newly identified adverse events and any other factors affecting safety and efficacy of Sprycel® so that the regulatory authority can manage the marketing approval properly.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
670

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

October 1, 2011

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

October 10, 2011

Completed
24 days until next milestone

First Posted

Study publicly available on registry

November 3, 2011

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

April 27, 2016

Status Verified

March 1, 2016

Enrollment Period

3.8 years

First QC Date

October 10, 2011

Last Update Submit

April 25, 2016

Conditions

Leukemia, Myelomonocytic, ChronicLeukemia-Lymphoma

Outcome Measures

Primary Outcomes (1)

  • Adverse events occurrence

    30 days after last dose of study drug

Secondary Outcomes (3)

  • Improvement in hematologic response

    4 weeks after registration

  • Improvement in cytogenetic response

    12 weeks after registration

  • Overall efficacy assessment by investigator's discretion

    4 weeks after registration

Study Arms (1)

Patients with CML or Ph+ ALL

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with chronic myeloid leukemia (CML) or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) who were never treated with Sprycel®

You may qualify if:

  • Newly diagnosed with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase
  • Adults with chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including Imatinib
  • Adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL) with resistance or intolerance to prior therapy

You may not qualify if:

  • According to Warning/Caution in local label

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Local Institution

Seoul, 110-756, South Korea

Location

Related Links

MeSH Terms

Conditions

Leukemia, Myelomonocytic, Chronic

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsMyelodysplastic-Myeloproliferative DiseasesBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2011

First Posted

November 3, 2011

Study Start

October 1, 2011

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

April 27, 2016

Record last verified: 2016-03

Locations

KR(1)