Efficacy and Safety Assessment of NIlotinib in CML Patients With Suboptimal Response on Imatinib Therapy (NISRI)
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|ClinicalTrials.gov Identifier: NCT02086487|
Recruitment Status : Terminated (Because of many unseen obstacles resulted in poor accrual, study is terminated.)
First Posted : March 13, 2014
Last Update Posted : March 7, 2017
|Condition or disease||Intervention/treatment||Phase|
|Myeloid Leukemia, Chronic||Drug: Nilotinib 300 mg.||Phase 4|
This is a multicenter, open label trial which will be conducted within Kingdom of saudi Arabia for which CML (Chronic Myeloid Leukemia) patients who meet eligibility criteria and showing sub optimal response to Imatinib therapy as per European leukemia Net ELN 2013 guidelines will be recruited and switched to Nilotinib 300 mg twice a day therapy.
Efficacy assessments of hematologic and cytogenetic response and disease progression, will be performed every 6 months at a minimum, including hematologic analysis, bone marrow cytogenetics, and molecular studies to ensure that nilotinib is being provided to patients who were responding and that patients who progressed could discontinue therapy.
Safety assessments include evaluation of adverse events, hematologic assessment, biochemical testing, cardiac enzyme assessment, serial electrocardiogram evaluation, and physical examination. Adverse events are graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0. Survival will be dated from start of nilotinib therapy until death from any cause and censored at last follow-up for patients who were alive.
The data will be summarized with respect to demographic and baseline characteristics, efficacy evaluation, and safety observations and measurements.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||98 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy and Safety Assessment of NIlotinib in CML Patients With Suboptimal Response on Imatinib Therapy (NISRI)|
|Study Start Date :||March 2013|
|Actual Primary Completion Date :||August 2016|
|Actual Study Completion Date :||August 2016|
Experimental: Nilotinib 300 mg
Patients diagnosed with chronic myeloid leukemia receiving treatment of Imatinib 400 mg but show sub-optimal response on Imatinib therapy as per the ELN 2013 guidelines will be switched to Nilotinib 300 mg twice daily and will be assessed for timely.
In the absence of safety concerns, nilotinib could be escalated to 400 mg twice daily if patients had not obtained any of the following milestones:
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%)
Other Name: Tasigna 300 mg
- The primary efficacy variable of this study is the overall Major molecular response at 12 month after starting Nilotinib 300mg twice daily for patient who suboptimally responded to Imatinib as per the ELN guidelines [ Time Frame: 12 Months ]
- Rate of cytogenetic response (complete cytogenetic response CCyR and Major cytogenetic response MCyR) and Major molecular response MMR at 3, 6 and 12 months of starting Nilotinib in patients who had a suboptimal response on Imatinib. [ Time Frame: 12Months ]
- Rate of CCyR at 6 months and MMR at 6 and 12 months from Nilotinib dose escalating to 400 mg BID. [ Time Frame: 12 months ]
- Rate and duration of Complete Hematologic Response CHR. [ Time Frame: 12 months ]
- Rate of CMR at 12 months of Nilotinib. [ Time Frame: 12 months ]
- Comparison of FISH results with conventional cytogenetics at 3, 6 & 12 months. [ Time Frame: 12 ]
- Overall survival. [ Time Frame: 12 ]
- Mutational analysis for the patients with suboptimal response at the pre defined end points as per the ELN guidelines. [ Time Frame: 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02086487
|National Guard Hospital|
|Riyadh, Central, Saudi Arabia, 11426|
|King Fahad specialist Hospital|
|Dammam, Eastern, Saudi Arabia|
|Principal Investigator:||Dr. Ahmad S. Alaskar, MD,FACP,FRCP||King Abdulaziz Medical City|