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Efficacy and Safety Assessment of NIlotinib in CML Patients With Suboptimal Response on Imatinib Therapy

NCT02086487 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2017-03-07

No results posted yet for this study

Summary

whether Nilotinib at the two sequential dosage forms will induce quicker and deeper response in those patients, and if FISH on PB (Peripheral blood) would be an effective way to monitor response compared to conventional cytogenetics on bone marrow (BM) sample

Conditions

  • Myeloid Leukemia, Chronic

Interventions

DRUG

Nilotinib 300 mg.

Patients diagnosed with chronic myeloid leukemia receiving treatment of Imatinib 400 mg once a day but are determined to be sub-optimally responding to Imatinib therapy as per the ELN 2013 guidelines will be switched to Nilotinib 300 mg BID and then will be assessed for therapy response. ELN guidelines 2013 for imatinib therapy response states as: Minor cytogenetic response mCyR or minimal response at 3 months (Ph+ metaphases in BM 35 to 95 %); BCR-ABL1 transcript \> 10% at 3 months; Partial cytogenetic response at 6 months Ph+ metaphases in BM 0to 35); BCR-ABL1 transcript is 1 to 10% at 6 months. Less than a major molecular response at \> 12 months; i.e (BCR-ABL1 0.1 -1%)

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • King Abdullah International Medical Research Center

    lead OTHER

Principal Investigators

  • Dr. Ahmad S. Alaskar, MD,FACP,FRCP · King Abdulaziz Medical City

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2016-08-31
Completion
2016-08-31

Countries

  • Saudi Arabia

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02086487 on ClinicalTrials.gov