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Sponsored by: |
Gruppo Italiano Malattie EMatologiche dell'Adulto |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00769327 |
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.
Condition | Intervention | Phase |
---|---|---|
Leukemia |
Drug: imatinib mesylate Drug: nilotinib Procedure: cytogenetic analysis Procedure: fluorescence in situ hybridization Procedure: gene expression profiling Procedure: laboratory biomarker analysis Procedure: mutation analysis Procedure: polymerase chain reaction Procedure: polymorphism analysis |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label |
Official Title: | Front-Line Treatment of Philadelphia Positive (Ph Pos), BCRABL Positive, Chronic Myeloid Leukemia (CML) With Two Tyrosine Kinase Inhibitors (TKI) (Nilotinib and Imotinib) A Phase II Exploratory Multicentric Centre. |
Estimated Enrollment: | 114 |
Study Start Date: | November 2008 |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Cytologically and cytogenetically confirmed chronic myelogenous leukemia meeting the following criteria:
PATIENT CHARACTERISTICS:
Normal serum levels of the following or correctable with supplements:
No impaired cardiac function, including any of the following:
No significant electric heart abnormalities, including any of the following:
PRIOR CONCURRENT THERAPY:
Study ID Numbers: | CDR0000615008, GIMEMA-CML0408, EUDRACT-2008-004384-19, EU-20881 |
Study First Received: | October 8, 2008 |
Last Updated: | October 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00769327 |
Health Authority: | Unspecified |
Philadelphia chromosome positive chronic myelogenous leukemia chronic phase chronic myelogenous leukemia |
Imatinib Philadelphia Chromosome Leukemia Chronic myelogenous leukemia Hematologic Diseases |
Myeloproliferative Disorders Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid, Chronic-Phase Leukemia, Myeloid Bone Marrow Diseases |
Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |