NCT03454503

Brief Summary

The purpose of this observational study is to evaluate the effectiveness and safety of generic imatinib under usual clinical practice in patients of Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) patients in chronic phase (CP) in Egypt

Trial Health

87
On Track

Trial Health Score

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

Enrollment
173

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2018

Typical duration 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

First Submitted

Initial submission to the registry

February 26, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 6, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

May 13, 2018

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2020

Completed
Last Updated

February 23, 2021

Status Verified

March 1, 2020

Enrollment Period

2.6 years

First QC Date

February 26, 2018

Last Update Submit

February 22, 2021

Conditions

Philadelphia Chromosome-positive Chronic Myeloid Leukemia in Chronic Phase

Keywords

ImatinibGeneric ImatinibLeukemiaChronic myeloid leukemiaPhiladelphia chromosome-positiveChronic phaseObservational studySwitched patientsTyrosine kinase inhibitor

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients who achieve and maintain major molecular response (MMR)

    Major molecular response (MMR) is measured using real-time quantitative polymerase chain reaction (RQ-PCR) test and is defined as BCR-ABL1 ≤ 0.1%

    12 months

Secondary Outcomes (9)

  • Incidence of adverse events (AEs) and serious adverse events (SAEs) to generic Imatinib (Carcemia®)

    18 months

  • Progression free survival (PFS)

    18 months

  • Event free survival (EFS)

    18 months

  • Survival without blastic phase (BP)

    18 months

  • Overall survival (OS)

    18 months

  • +4 more secondary outcomes

Study Arms (2)

First cohort

Newly diagnosed patients

Drug: Imatinib

Second cohort

Patients switched from reference product (Glivec® )

Drug: Imatinib

Interventions

ImatinibDRUG

Film coated tablet contains 400 mg imatinib (as mesilate)

Also known as: Carcemia®
First cohortSecond cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients will be recruited from 2 sites in Egypt

You may qualify if:

  • First cohort (newly diagnosed patients):
  • Age ≥18 years
  • Newly diagnosed patients with Ph+ CML in CP, with or without the presence of other cytogenetic abnormalities at the time of diagnosis
  • Treatment naïve patients with confirmed diagnosis within 3 months of study enrolment
  • Levels of liver aminotransferases and serum bilirubin ≤ 2 times the upper limit of the normal range, and serum creatinine ≤1.5 times the upper limit of the normal range
  • Written informed consent
  • Second cohort (switched patients):
  • Age ≥18 years
  • Ph+ CML patients in CP currently treated with Glivec®, with or without the presence of other cytogenetic abnormalities at the time of switch
  • Levels of liver aminotransferases and serum bilirubin ≤ 2 times the upper limit of the normal range and serum creatinine ≤1.5 times the upper limit of the normal range
  • Written informed consent

You may not qualify if:

  • CML in accelerated phase (AP) at enrollment except patients in AP with the presence of other cytogenetic abnormalities at the time of diagnosis
  • CML in BP at enrollment
  • Patients who meet any of the contraindications to the administration of the study drug according to the approved Summary of Product Characteristics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Institute (NCI)

Cairo, 11796, Egypt

Location

MeSH Terms

Conditions

LeukemiaLeukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

Imatinib Mesylate

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, MyeloidMyeloproliferative DisordersBone Marrow DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic ChemicalsBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidines

Study Design

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

Study Record Dates

First Submitted

February 26, 2018

First Posted

March 6, 2018

Study Start

May 13, 2018

Primary Completion

December 28, 2020

Study Completion

December 28, 2020

Last Updated

February 23, 2021

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)