Nilotinib and Imatinib Mesylate in Treating Patients With Early Chronic Phase Chronic Myelogenous Leukemia
- Conditions
- Leukemia
- Registration Number
- NCT00769327
- Brief Summary
RATIONALE: Nilotinib and imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well giving nilotinib together with imatinib mesylate works in treating patients with early chronic phase chronic myelogenous leukemia.
- Detailed Description
OBJECTIVES:
Primary
* To assess the complete cytogenetic response rate at 12 months in patients with Philadelphia chromosome- and BCR-ABL-positive early chronic phase chronic myelogenous leukemia treated with nilotinib and imatinib mesylate.
Secondary
* To assess the complete cytogenetic response rate at 6 and 24 months in these patients.
* To assess the major and complete molecular response rate at 6, 12, and 24 months in these patients.
* To assess the frequency and the types of BCR-ABL kinase domain mutations at 24 months during and for 3 years after study treatment.
* To assess the rate of failures and the time to failure at 12, 24, and 60 months in these patients.
* To assess compliance, toxicity, and adverse events in these patients.
* To understand the relationship between response, gene expression profile, biomarkers, and drug plasma concentrations in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral nilotinib twice daily in months 1-3, 7-9, 13-15, and 19-21 and oral imatinib mesylate once daily in months 4-6, 10-12, 16-18, and 22-24. Treatment continues for 24 months in the absence of disease progression or unacceptable toxicity. Patients may be eligible to continue oral nilotinib and oral imatinib mesylate for up to another 36 months if it is in the interest of the patient.
Blood samples and bone marrow biopsies are collected periodically for cytogenetic response by chromosome banding analysis and FISH analysis; real-time quantitative PCR mutational analysis and single nucleotide polymorphism analysis of BCR-ABL transcripts; and gene expression profiling and correlative biomarker studies.
After completion of study therapy, patients are followed every 6 months for 3 years and then every 12 months for 5 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 129
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Complete cytogenetic response rate At 12 months from study entry
- Secondary Outcome Measures
Name Time Method Major and complete molecular response rate At at 6, 12 and 24 months from study entry Relationship between response, the gene expression profile, the biomarkers of leukemic cells, and plasma concentrations of nilotinib and imatinib mesylate At 24 months from study entry Complete cytogenetic response At at 6 and 24 months from study entry Development of BCR-ABL kinase domain mutations (number, timing, and type) At at 24 months during and for 3 years after study treatment Rate of failures and the time to failure At 12, 24, and 60 months from study entry Safety and tolerability At 24 months from study entry Frequency and type of adverse events (AE) and severe AE At 24 months from study entry
Trial Locations
- Locations (37)
Centro Oncologico Basilicata
🇮🇹Rionero in Vulture, Potenza, Italy
Unità di Oncoematologia Azienda Ospedaliera Garibaldi
🇮🇹Catania, Italy
Dip. di Scienze Cliniche e Biologiche - Ospedale S. Luigi Gonzaga
🇮🇹Orbassano, Italy
Ospedali Riuniti "Villa Sofia-Cervello"
🇮🇹Palermo, Italy
Unità Operativa Ematologia e Centro Trapianti - Dipartimento di Oncologia ed Ematologia - AUSL Ospedale di Piacenza
🇮🇹Piacenza, Italy
Dipartimento Emato-Oncologia A.O."Bianchi-Melacrino-Morelli"
🇮🇹Reggio Calabria, Italy
SCDO Ematologia 2 AOU S.Giovanni Battista
🇮🇹Torino, Italy
Policlinico Universitario Udine
🇮🇹Udine, Italy
Ospedale San Bortolo
🇮🇹Vicenza, Italy
Dipartimento Area Medica P.O.
🇮🇹Ascoli Piceno, Italy
Ospedale Civile Alessandria
🇮🇹Alessandria, Italy
S.G. Moscati Hospital
🇮🇹Avellino, Italy
Unità Operativa Ematologia 1 - Università degli Studi di Bari
🇮🇹Bari, Italy
Ospedali Riuniti di Bergamo
🇮🇹Bergamo, Italy
Ist.Ematologia e Oncologia Medica L.e A. Seragnoli
🇮🇹Bologna, Italy
ASL N.8 - Ospedale "A. Businco" - Struttura Complessa di Ematologia e CTMO
🇮🇹Cagliari, Italy
Ctc U.O Di Ematologia Con Trapianto Di Midollo Osseo - Catania
🇮🇹Catania, Italy
Azienda Ospedaliera Pugliese Ciaccio - Presidio Ospedaliero A.Pugliese - Unità Operativa di Ematologia
🇮🇹Catanzaro, Italy
Sez.Ematologia e Dip. scienze Biomediche Arcispedale S. Anna
🇮🇹Ferrara, Italy
Azienda Ospedaliera di Firenze
🇮🇹Firenze, Italy
Struttura Complessa di Ematologia Ospedali Riuniti Foggia - Azienda Ospedaliero-Universitaria
🇮🇹Foggia, Italy
Clinica Ematologica - DiMI - Università degli Studi di Genova
🇮🇹Genova, Italy
Clinica Ematologica - Università degli Studi
🇮🇹Genova, Italy
A.O. Universitaria Policlinico Martina di Messina
🇮🇹Messina, Italy
Azienda ospedaliera Ospedali Riuniti "Papardo Piemonte"
🇮🇹Messina, Italy
Sez. di medicina Interna Oncologia ed Ematologia
🇮🇹Modena, Italy
Universtià degli Studi di Napoli "Federico II" - Facoltà di medicina e chirurgia
🇮🇹Napoli, Italy
S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro
🇮🇹Novara, Italy
U.O. Ematologia Clinica - Azienda USL di Pescara
🇮🇹Pescara, Italy
A.O Umberto I
🇮🇹Roma, Italy
Complesso Ospedaliero S. Giovanni Addolorata
🇮🇹Roma, Italy
Unità operativa complessa di Ematologia
🇮🇹Reggio Emilia, Italy
Ospedale S.Eugenio
🇮🇹Roma, Italy
Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza
🇮🇹San Giovanni Rotondo, Italy
U.O. Ematologia, Azienda Ospedaliera Universitaria Senese
🇮🇹Siena, Italy
Azienda ospedaliera S. Maria di Terni
🇮🇹Terni, Italy
Policlinico G. B. Rossi - Borgo Roma
🇮🇹Verona, Italy