Study of Nilotinib as First Line Treatment in Philadelphia Chromosome Positive(Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) (MACS0816)
This study is currently recruiting participants.
Verified May 2012 by Novartis
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01274351
First received: January 4, 2011
Last updated: May 14, 2012
Last verified: May 2012
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Purpose
This study is designed to investigate the molecular and cytogenetic effects and safety profile of nilotinib in the treatment of early chronic phase of Ph+ CML among different risk groups of patients and to compare patients with high Socal risk score with patients having intermediate and low Socal risk score.
Condition | Intervention | Phase |
---|---|---|
Chronic Myelogenous Leukemia |
Drug: Tasigna |
Phase 4 |
Study Type: | Interventional |
Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
Official Title: | A Phase II Multi-center, Open-label, Non-randomized Study of Nilotinib as First Line Treatment in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) |
Resource links provided by NLM:
Genetics Home Reference related topics:
17q21.31 microdeletion syndrome
isodicentric chromosome 15 syndrome
tetrasomy 18p
Drug Information available for:
Nilotinib
U.S. FDA Resources
Further study details as provided by Novartis:
Primary Outcome Measures:
- Rate of major molecular response (MMR) by 12 months and comparison of major molecular response (MMR) rates by 12 months between high sokal risk patients and low&intermediate sokal risk patients [ Time Frame: 3 monthly intervals until 12 month ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Rate of complete cytogenetic response (CCyR) by 6 and 12 months [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
- Rate of molecular response at 3 monthly basis [ Time Frame: 3 monthly intervals ] [ Designated as safety issue: No ]
- Rate of hematologic response [ Time Frame: 3 monthly intervals ] [ Designated as safety issue: No ]
- Number of patients with adverse events [ Time Frame: Every visit ] [ Designated as safety issue: Yes ]
- Time and duration of major molecular response (MMR) [ Time Frame: 3 monthly intervals ] [ Designated as safety issue: No ]
Estimated Enrollment: | 110 |
Study Start Date: | January 2011 |
Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Experimental: Nilotinib | Drug: Tasigna |
Eligibility
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
- First cytogenetic diagnosis of CML-CP with cytogenetic confirmation of Philadelphia chromosome of (9;22) translocations within 6 months. Standard conventional cytogenetic analysis must be performed.
- Previously untreated for CML, except for hydroxyurea and/or anagrelide (except imatinib treatment for max. 31 days long)
- Adequate end organ function with following laboratory criteria: total bilirubin < 1.5 x upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 x upper limit of normal (ULN); creatinine < 1.5 x upper limit of normal (ULN); serum amylase and lipase ≤ 1.5 x upper limit of normal (ULN); alkaline phosphatase ≤ 2.5 x upper limit of normal (ULN) unless considered tumor related
- Serum potassium, magnesium, and phosphorus levels are equal or above the lower limit of normal prior to the first dose of study medication
Exclusion Criteria:
- Treatment with tyrosine kinase inhibitor(s) prior to study (in emergent cases where the patient requires disease management while awaiting study start, commercial supplies of imatinib at any dose may be prescribed to the patient but for no longer than 31 days in duration)
- Known cytopathologically confirmed Central Nervous System CNS infiltration
- Impaired cardiac function
- Severe or uncontrolled medical conditions (i.e. uncontrolled diabetes, active or uncontrolled infection)
- Acute or chronic liver, pancreatic or severe renal disease considered unrelated to disease
- Patients with another primary malignancy except if the other primary malignancy is neither currently clinically significant or requiring active intervention
- History of significant congenital or acquired bleeding disorder unrelated to cancer
- Previous radiotherapy to ≥25% of the bone marrow
- Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection, or gastric bypass surgery)
- Use of therapeutic coumarin derivatives (i.e. warfarin, acenocoumarol, phenprocoumon)
- Patients actively receiving therapy with strong Cytochrome P450 3A4 isoenzyme (CYP3A4) inhibitors (e.g, erythromycin, ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin, ritonavir, mibefradil)
- Patients actively receiving therapy with medications that have the potential to prolong the QT interval and the treatment cannot be either discontinued or switched to a different medication prior to starting study drug
Other protocol-defined inclusion/exclusion criteria may apply
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01274351
Contacts
Contact: Novartis Pharmaceuticals | +1(800)340-6843 |
Locations
Turkey | |
Novartis Investigative Site | Recruiting |
Adana, Turkey, 01330 | |
Novartis Investigative Site | Recruiting |
Ankara, Turkey, 06100 | |
Novartis Investigative Site | Withdrawn |
Antalya, Turkey, 07070 | |
Novartis Investigative Site | Recruiting |
Bursa, Turkey, 16059 | |
Novartis Investigative Site | Recruiting |
Diyarbakir, Turkey, 21000 | |
Novartis Investigative Site | Not yet recruiting |
Gaziantep, Turkey, 27070 | |
Novartis Investigative Site | Recruiting |
Istanbul, Turkey, 34303 | |
Novartis Investigative Site | Recruiting |
Istanbul, Turkey, 34093 | |
Novartis Investigative Site | Recruiting |
Izmir, Turkey, 35040 | |
Novartis Investigative Site | Recruiting |
Izmir, Turkey, 35340 | |
Novartis Investigative Site | Recruiting |
Meselik / Eskisehir, Turkey, 26480 | |
Novartis Investigative Site | Recruiting |
Okmeydani / Istanbul, Turkey, 34370 | |
Novartis Investigative Site | Recruiting |
Talas / Kayseri, Turkey, 38039 | |
Novartis Investigative Site | Recruiting |
Trabzon, Turkey, 61080 |
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
No publications provided
Keywords provided by Novartis:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 18, 2012
No publications provided
Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
ClinicalTrials.gov Identifier: | NCT01274351 History of Changes |
Other Study ID Numbers: | CAMN107ETR02 |
Study First Received: | January 4, 2011 |
Last Updated: | May 14, 2012 |
Health Authority: | United States: Food and Drug Administration Turkey: Ministry of Health |
Keywords provided by Novartis:
First line treatment newly diagnosed Philadelphia chromosome positive Chronic Myelogenous Leukemia |
Ph+ CML-CP major molecular response Social risk |
Additional relevant MeSH terms:
Leukemia Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Philadelphia Chromosome Neoplasms by Histologic Type Neoplasms |
Myeloproliferative Disorders Bone Marrow Diseases Hematologic Diseases Translocation, Genetic Chromosome Aberrations Pathologic Processes |
ClinicalTrials.gov processed this record on October 18, 2012