Nilotinib as First-line Treatment of Ph+ CML in Early Chronic Phase (CML0307)
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|ClinicalTrials.gov Identifier: NCT00481052|
Recruitment Status : Completed
First Posted : June 1, 2007
Last Update Posted : October 8, 2020
|Condition or disease||Intervention/treatment||Phase|
|Chronic Myeloid Leukemia||Drug: Nilotinib||Phase 2|
Phase II, Prospective, multicentric, non randomized, open label
The primary objective of the trial is to investigate the cytogenetic and molecular effects of the protein tyrosine kinase (PTK) inhibitor nilotinib in the treatment of early chronic phase Ph+ CML.
The secondary objectives are:
To investigate in early CP Ph+ CML patients treated with nilotinib the clinical and the hematologic effects, the effect on bcr/abl point mutations, the kinetic of the response, the toxicity, the compliance to treatment and the dose density.
This study is an open-label, multicenter, exploratory, Phase II study of nilotinib administered orally twice daily for one year. For the patients who will benefit an extension to 4 years is planned.
Visit Schedule and Assessments:
A visit with blood counts and differential and serum chemistry is due baseline, every 15 days for 3 months, hence every 30 days.
An ECG is due baseline, after 15 and 30 days, hence at 60, 90, 150, 240 and 360 days.
An echocardiogram is due baseline and at end-of-study (360 days) or early withdrawal.
A bone marrow aspirate is due baseline (cytology, cytogenetics and quantitative molecular biology), after 3 and 6 months (cytology and cytogenetics) and after 12 months (cytology, cytogenetics, quantitative molecular biology and mutational analysis).
A peripheral blood sample is due baseline, at 30, 60, 90, 180, 270 and 360 days for quantitative molecular biology.
After the end of the study (i.e. after one year) clinical, cytogenetic and molecular data are due every 6 months.
Bone marrow and peripheral blood cells will be collected before, during and at the end of the study, stored at the central lab in Bologna and used for molecular assays that are listed in details in the protocol, with the exclusion of any test allowing the identification of patients genotype. The samples are kept for a minimum of 10 years and can be destroyed upon patient request. A specific consent form to the sample storage will be submitted to the patients.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||74 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Protein Tyrosine Kinase Inhibitor Nilotinib as First-line Treatment of Ph+ Chronic Myeloid Leucemia (CML) in Early Chronic Phase: a Phase II Exploratory, Multicenter Study. GIMEMA Protocol CML 0307. EUDRACT 2007-000597-22.|
|Actual Study Start Date :||June 23, 2007|
|Actual Primary Completion Date :||April 30, 2018|
|Actual Study Completion Date :||April 30, 2018|
- Complete cytogenetic response (CCgR ) rate [ Time Frame: At 1 year ]
- The complete and the partial cytogenetic response rate [ Time Frame: At 6 months ]
- The major molecular response (MMR) rate [ Time Frame: At 1 year ]
- The kinetics of haematologic, cytogenetic and molecular response to AMN107 [ Time Frame: At 1 year ]
- The development of bcr-abl mutation during the treatment with AMN107 (number and type) [ Time Frame: At 1 year ]
- The safety and tolerability of nilotinib treatment at the dose of 300 mg b.i.d [ Time Frame: At 1 year ]
- To describe any SAE [ Time Frame: At 1 year ]
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): NCT00481052
|Principal Investigator:||Michele BACCARANI||Azienda Ospedaliera Universitaria -Policlincio S. Orsola-Malpighi|