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Trial to Evaluate the Improvement of Chronic Low-grade AEs in Patients With Ph+ CML With Optimal Response to Imatinib When Switched to Nilotinib | Clinical Trials | Clareo Health

TERMINATEDPHASE3

Trial to Evaluate the Improvement of Chronic Low-grade AEs in Patients With Ph+ CML With Optimal Response to Imatinib When Switched to Nilotinib

Open-label Multicenter Trial to Evaluate the Improvement of Chronic Low-grade Adverse Events Experienced by Patients With Ph+ Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) With Optimal Response to Imatinib When Switched From Imatinib to Nilotinib Treatment

NCT02115386•Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

Primary Objective for this study is to evaluate changes in chronic low grade non-hematological adverse events experienced by patients who have been treated with at least 6 months of imatinib and who have not responded to supportive measures, when they are switched to nilotinib (CTCAE grading system).

Detailed Description

Study was terminated by Novartis

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female patients ≥ 18 years of age 2. ECOG ≤ 2 3. Diagnosis of CML-CP \< 15% blasts in peripheral blood and bone marrow
•\< 30% blasts plus promyelocytes in peripheral blood and bone marrow
•\< 20% basophiles in the peripheral blood
•≥ 100 x 109 /L platelets
•No evidence of extramedullary leukemic involvement, with the exception of hepatosplenomegaly. 4. Minimal treatment duration before inclusion is 6 months. 5. Optimal response to imatinib at the time of inclusion according to LeukemiaNet 2009 criteria defined as:
•Patients treated with imatinib for ≥6 and \<12 months must be in MCR Patients treated with imatinib for ≥12 and \<18 months must be in CCR
•Patients treated with imatinib for ≥18 months must be in MMR (MMR response defined either as 3 log reduction of bcr-abl/abl ratio or as 0,1% by IS). 6. Initial treatment with 400mg imatinib with current treatment with imatinib 400 or 300 mg QD 7. Imatinib dose interruptions are allowed prior to inclusion but should not exceed 28 consecutive days 8. Persistent Grade 1- 2 non-hematological adverse events for at least 2 months despite best supportive care. Toxicity was to be evaluated by treating physician using CTCAE criteria. 9. In case of several types of non-hematological AEs no one can exceed grade 2 and at least one should last at least 2 months. 10. Adequate end organ function defined by:
•Total bilirubin \< 1.5 x ULN
•AST and ALT \< 2.5 x ULN
•Creatinine \< 1.5 x ULN
+2 more criteria

Exclusion Criteria

•1. Patients who have experienced any Grade 3 or higher non-hematologic toxicity 30 days prior to screening
•2. Loss of response (hematologic, cytogenetic, molecular) any time prior to inclusion
•3. Prior accelerated phase or blast phase CML
•4. Previously documented T315I mutation
•5. Chromosomal abnormalities (trisomy 8) and/or clonal evolution other than Ph+.
•6. Previous treatment with imatinib \>400 mg any time prior to inclusion.
•7. Previous treatment with any other tyrosine kinase inhibitors except for only imatinib
•Impaired cardiac function including any of the following:
•LVEF \< 45% as determined by echocardiogram reading or MUGA
•Complete left bundle branch block
+9 more criteria

Locations (1)

Novartis Investigative Site

Moscow, Russia

Key Dates

Start Date

December 17, 2015

Primary Completion Date

October 31, 2016

Completion Date

October 31, 2016

Last Updated

December 10, 2019

Enrollment

ACTUAL participants

Conditions

Philadelphia Positive (Ph+) Chronic Myeloid Leukemia

Interventions

Nilotinib

DRUG