NCT03228303

Brief Summary

Nilotinib vs imatinib in patients with newly diagnosed CML-CP

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Dec 2017

Typical duration for early_phase_1

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

July 16, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 24, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2017

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2020

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

October 10, 2017

Status Verified

October 1, 2017

Enrollment Period

2.7 years

First QC Date

July 16, 2017

Last Update Submit

October 7, 2017

Conditions

Chronic Myeloid Leukemia

Outcome Measures

Primary Outcomes (4)

  • Nilotinib vs imatinib in patients with newly diagnosed CML-CP: Overall survival rate in years

    Overall survival rate in years

    3 years cutoff

  • Nilotinib vs imatinib in patients with newly diagnosed CML-CP: Cholesterol level in mg

    cholesterol level in mg

    3 years cutoff

  • Nilotinib vs imatinib in patients with newly diagnosed CML-CP: Heart state by assessment by ECG

    heart state by assessment by ECG

    3 years cutoff

  • Nilotinib vs imatinib in patients with newly diagnosed CML-CP: Free survival rate in years

    free survival rate in years

    3 years cutoff

Study Arms (2)

Chronic phase CML treated by nilotinib

ACTIVE COMPARATOR

Newly diagnosed

Drug: Nilotinib 150 MG [Tasigna]

Chronic phase CML treated by imatinib

ACTIVE COMPARATOR

Newly diagnosed

Drug: Imatinib 400mg

Interventions

Nilotinib 150 MG [Tasigna]DRUG

Nilotinib vs imatinib in patients with newly diagnosed CML-CP

Chronic phase CML treated by nilotinib
Imatinib 400mgDRUG

Nilotinib vs imatinib in patients with newly diagnosed CML-CP

Chronic phase CML treated by imatinib

Eligibility Criteria

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

You may qualify if:

  • chronic phase CML not received treatment
  • Pts with no heart disease
  • Pts with no abnormal cholesterol level

You may not qualify if:

  • Any pts treated before with diff. Treatment
  • Pts. With past history of heart problems
  • Pts. With abnormal cholesterol level

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

nilotinibImatinib 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)

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

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ClinIcal professor

Study Record Dates

First Submitted

July 16, 2017

First Posted

July 24, 2017

Study Start

December 1, 2017

Primary Completion

July 30, 2020

Study Completion

August 1, 2020

Last Updated

October 10, 2017

Record last verified: 2017-10