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NCT02272777

A Study of Imatinib and Nilotinib in Patients With Chronic Myelogenous Leukemia in Chronic Phase

Completed Phase 3 Results posted Last updated 19 August 2019
What this trial tests

Phase 3 trial testing Imatinib in Leukemia in 225 participants. Completed in 30 January 2017.

Timeline
17 July 2014
Primary endpoint
30 January 2017
30 January 2017

Quick facts

Lead sponsorNovartis Pharmaceuticals
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment225
Start date17 July 2014
Primary completion30 January 2017
Estimated completion30 January 2017
Sites12 locations across China

Drugs / interventions tested

Conditions studied

Sponsor

Novartis Pharmaceuticals — full company profile →

Who can join

18 and older, any sex, with Leukemia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Primary · From first dose of study treatment to 30 days after last dose of study treatment, up to 31 months

Clinically significant changes in laboratory values and vital signs were reported as AEs or SAEs, as appropriate. Only descriptive analysis.

Adverse Events (AEs)
GroupValue95% CI
Imatinib82
Nilotinib84
Serious Adverse Events (SAEs)
GroupValue95% CI
Imatinib1
Nilotinib3
Fatal SAEs
GroupValue95% CI
Imatinib0
Nilotinib0
AEs leading to drug discontinuation
GroupValue95% CI
Imatinib0
Nilotinib1
AEs leading to dose adjustment/interruption
GroupValue95% CI
Imatinib17
Nilotinib17

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse Events were collected for the maximum duration of participants' treatment exposure up to 29.3 months, plus 30 days follow up period.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Imatinib
Serious: 1/112 (1%)
Deaths: 0/112
Nilotinib
Serious: 3/113 (3%)
Deaths: 0/113

Serious adverse events (4 terms)

ReactionSystemImatinibNilotinib
EnteritisGastrointestinal disorders——
CholelithiasisHepatobiliary disorders——
FractureMusculoskeletal and connective tissue disorders——
Cerebral infarctionNervous system disorders——
Other adverse events (31 terms — click to expand)

ReactionSystemImatinibNilotinib
Blood bilirubin increasedInvestigations——
Blood triglycerides increasedInvestigations——
AstheniaGeneral disorders——
Blood cholesterol increasedInvestigations——
LeukopeniaBlood and lymphatic system disorders——
Blood phosphorus decreasedInvestigations——
White blood cell count decreasedInvestigations——
Memory impairmentNervous system disorders——
AnaemiaBlood and lymphatic system disorders——
Upper respiratory tract infectionInfections and infestations——
Alanine aminotransferase increasedInvestigations——
Blood creatinine increasedInvestigations——
Blood glucose increasedInvestigations——
Muscle spasmsMusculoskeletal and connective tissue disorders——
Skin discolourationSkin and subcutaneous tissue disorders——
ThrombocytopeniaBlood and lymphatic system disorders——
NauseaGastrointestinal disorders——
Blood creatine phosphokinase increasedInvestigations——
High density lipoprotein decreasedInvestigations——
Lipase increasedInvestigations——
Low density lipoprotein increasedInvestigations——
Weight increasedInvestigations——
HyperuricaemiaMetabolism and nutrition disorders——
HypophosphataemiaMetabolism and nutrition disorders——
InsomniaPsychiatric disorders——
NeutropeniaBlood and lymphatic system disorders——
Chest discomfortGeneral disorders——
InfluenzaInfections and infestations——
MyalgiaMusculoskeletal and connective tissue disorders——
AnxietyPsychiatric disorders——
AlopeciaSkin and subcutaneous tissue disorders——

Most-reported serious reactions: Enteritis, Cholelithiasis, Fracture, Cerebral infarction.

Data from ClinicalTrials.gov NCT02272777 adverse events section.

Sponsor's own description

The extension study followed the core study CAMN107ECN02 (NCT01275196). which is an open-label, two armed study. All patients enrolled in this extension study were able to benefit from the treatment given in CAMN107ECN02 per investigator's evaluation. Therefore, in this extension study patient continued treatment of the drug (imatinib or nilotinib) which they were taking at the end of CAMN107ECN02. Treatment arms in CAMN107ECN02 were retained. As long as EC approval and agreement from investigators were obtained, the selected sites for CAMN107ECN02 were applied in this extension study.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Chronic myeloid leukemia stem cells: targeting therapeutic implications.
    Mojtahedi H, Yazdanpanah N, Rezaei N. · · 2021 · cited 53× · PMID 34922630 · DOI 10.1186/s13287-021-02659-1

Verify or expand the search:

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Trials testing the same drug.

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Trials by the same sponsor.

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing