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Sponsored by: |
Gruppo Italiano Malattie EMatologiche dell'Adulto |
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Information provided by: | Gruppo Italiano Malattie EMatologiche dell'Adulto |
ClinicalTrials.gov Identifier: | NCT00481052 |
Treating Ph pos CML with Imatinib is very effective since the majority of the patients achieve a complete cytogenetic response and a major molecular response and are alive and progression-free after 5 years. However, the great majority of responding patients are not leukemia-free and may be at risk of progression, molecular, cytogenetic and clinical, at any time. In case of disease progression due to Imatinib failure, nilotinib has been found to be very effective, as expected from the preclinical profile of the drug, that is much more potent against BCR-ABL and inhibits nearly all the imatinib-resistant BCR-ABL mutants. For these reasons, nilotinib is going to be registered for the treatment of imatinib-resistant CMl patients. For the same reasons, nilotinib is expected to be more efficient than imatinib also front-line, based on the principle that we should aim at preventing the emergence of resistance better that at treating resistance once it has emerged. This expectation can be tested safely, beacuse the "toxicity profile" of Nilotinib may be even more convenient than that of Imatinib, due to the lower frequency of edema and fluid retention.
Condition | Intervention | Phase |
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Chronic Myeloid Leukemia |
Drug: Nilotinib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
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. |
Estimated Enrollment: | 70 |
Study Start Date: | June 2007 |
Study Phase:
Phase II, Prospective, multicentric, non randomized, open label
Objectives:
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.
Study design:
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.
Biologic Monitoring:
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 duration:
Enrollment time is 6 months. Treatment time is 12 months. Total trial time is 18 months. After 12 months all patients are followed and may continue the study drug.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion criteria:
Contact: Gianantonio ROSTI | +39 051-6364076 | gianantonio.rosti@unibo.it |
Italy | |
Dipartimento Area Medica P.O. | Not yet recruiting |
Ascoli Piceno, Italy, 63100 | |
Contact: Pietro GALIENI | |
Unità Operativa Ematologica - Università degli Studi di Bari | Not yet recruiting |
Bari, Italy, 70124 | |
Contact: Vincezo LISO | |
Ospedali Riuniti | Not yet recruiting |
Bergamo, Italy, 24100 | |
Contact: Angelo RAMBALDI | |
Azienda Ospedaliera Pugliese Ciaccio | Recruiting |
Catanzaro, Italy, 88100 | |
Contact: Antonio PETA | |
Azienda Spedali Civili | Not yet recruiting |
Brescia, Italy, 25100 | |
Contact: Domenico RUSSO | |
Clinica Ematologica - Università degli Studi | Not yet recruiting |
Genova, Italy | |
Contact: Marco GOBBI | |
Div. di Ematologia IRCCS Policlinico S. Matteo | Not yet recruiting |
Pavia, Italy, 27100 | |
Contact: Mario LAZZARINO | |
U.O. Ematologia Clinica - Azienda USL di Pescara | Not yet recruiting |
Pescara, Italy, 65100 | |
Contact: Giuseppe FIORITONI | |
Ospedale Ferrarotto | Not yet recruiting |
Catania, Italy, 95124 | |
Contact: Rosario GIUSTOLISI, Pr. | |
Ospedale S. Luigi Gonzaga | Not yet recruiting |
Orbassano, Italy, 10043 | |
Contact: Giuseppe SAGLIO | |
Ospedale S.Eugenio | Not yet recruiting |
Rome, Italy, 00144 | |
Contact: Paolo DE FABRITIIS | |
Azienda USL 9 Treviso - U.O. di Ematologia | Not yet recruiting |
Treviso, Italy, 31100 | |
Contact: Filippo GHERLINZONI | |
Policlinico di Tor Vergata | Not yet recruiting |
Rome, Italy, 00133 | |
Contact: Sergio AMADORI, Pr | |
Policlinico G.B. Rossi | Not yet recruiting |
Verona, Italy, 37134 | |
Contact: Giovanni PIZZOLO | |
Policlinico Universitario - Clinica Ematologia | Not yet recruiting |
Udine, Italy, 33100 | |
Contact: Renato FANIN, Pr | |
Complesso Ospedaliero S. Giovanni Addolorata | Not yet recruiting |
Roma, Italy, 00184 | |
Contact: Luciana ANNINO | |
Università La Cattolica del Sacro Cuore | Not yet recruiting |
Roma, Italy, 00168 | |
Contact: Giuseppe LEONE | |
Sez.Ematologia e Dip. scienze Biomediche Arcispedale S. Anna | Not yet recruiting |
Ferrara, Italy, 44100 | |
Contact: Antonio CUNEO | |
U.O. Ematologia, Azienda Ospedaliera Universitaria Senese | Not yet recruiting |
Siena, Italy, 53100 | |
Contact: Francesco LAURIA | |
Sezione di Ematologia e Trapianti Spedali Civili | Recruiting |
Brescia, Italy, 21125 | |
Contact: Giuseppe ROSSI | |
Ematologia 1 - Centro Trapianto di Midollo | Not yet recruiting |
Milano, Italy, 20122 | |
Contact: Giorgio LAMBERTENGHI | |
Ospedale S.Maria delle Croci | Not yet recruiting |
Ravenna, Italy, 48100 | |
Contact: Alfonso ZACCARIA |
Principal Investigator: | Michele BACCARANI | Azienda Ospedaliera Universitaria -Policlincio S. Orsola-Malpighi |
Study ID Numbers: | CML0307 |
Study First Received: | May 31, 2007 |
Last Updated: | August 28, 2007 |
ClinicalTrials.gov Identifier: | NCT00481052 |
Health Authority: | Italy: The Italian Medicines Agency |
Adult CML Philadelphia positive Nilotinib |
early chronic phase untreated or treated only with Hydroxyurea or Anagrelide Chronic Myeloid Leukemia |
Leukemia Chronic myelogenous leukemia Hydroxyurea Hematologic Diseases Myeloproliferative Disorders |
Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Bone Marrow Diseases Anagrelide |
Neoplasms Neoplasms by Histologic Type |