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Report for Clinical Trial NCT02086487

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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

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

NCT02086487 Myeloid Leukemia, Chronic
MeSH:Leukemia, Myelogenous, Chronic, BCR-ABL Positive
HPO:Chronic myelogenous leukemia

1 Interventions

Name: Nilotinib 300 mg.

Description: 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%)
Type: Drug
Group Labels: 1

Nilotinib 300 mg


Primary Outcomes

Measure: 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: 12 Months

Secondary Outcomes

Measure: 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: 12Months

Measure: Rate of CCyR at 6 months and MMR at 6 and 12 months from Nilotinib dose escalating to 400 mg BID.

Time: 12 months

Measure: Rate and duration of Complete Hematologic Response CHR.

Time: 12 months

Measure: Rate of CMR at 12 months of Nilotinib.

Time: 12 months

Measure: Comparison of FISH results with conventional cytogenetics at 3, 6 & 12 months.

Time: 12

Measure: Overall survival.

Time: 12

Other Outcomes

Measure: Mutational analysis for the patients with suboptimal response at the pre defined end points as per the ELN guidelines.

Time: 12 months

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 T315I

5. Pregnant or lactating females 6. Patients with prolonged QT intervals 7. Patient with history of pancreatitis 8. Previously documented T315I mutations; 9. Uncontrolled congestive heart failure or hypertension; 10. --- T315I ---



HPO Nodes


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