CMR Rate of Newly Diagnosed CML-CP Patients Treated With Nilotinib (MACS1428)
This study is currently recruiting participants.
Verified February 2013 by Novartis
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01227577
First received: October 21, 2010
Last updated: February 22, 2013
Last verified: February 2013
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Purpose
"This is a single-arm, open-label, multi-center study of complete molecular response (CMR) in adult patients with newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia in chronic phase (CML-CP). The study is designed to evaluate early and deep molecular responses up to 4 years on nilotinib treatment. The primary end point is Rate of confirmed CMR in newly diagnosed Philadelphia chromosome positive CML-CP patients."
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Myelogenous Leukemia in Chronic Phase |
Drug: nilotinib |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Single-arm, Open-label, Multi-center Study of Complete Molecular Response (CMR) 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:
tetrasomy 18p
Drug Information available for:
Nilotinib
U.S. FDA Resources
Further study details as provided by Novartis:
Primary Outcome Measures:
- Rate of confirmed Complete Molecular Response (CMR) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Rate of CCyR, MMR, CMR and sustained CMR [ Time Frame: 4 years or at the end of the study ] [ Designated as safety issue: Yes ]
- Time and Duration of CCyR, MMR, CMR and sustained CMR [ Time Frame: 4 years or until the end of the study ] [ Designated as safety issue: Yes ]
- Rate and Time to progression to AP/BC [ Time Frame: 4 years or until the end of the study ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 300 |
| Study Start Date: | November 2010 |
| Estimated Study Completion Date: | December 2017 |
| Estimated Primary Completion Date: | December 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: nilotinib |
Drug: nilotinib
nilotinib 300mg b.i.d. in adult patients with newly diagnosed Ph+ CML-CP.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
Patients with Ph+ CML-CP within 3 months of diagnosis. Male or female patients' ≥ 18 years of age. Patients must have adequate end organ function.
Exclusion Criteria:
Previously documented T315I mutation. Other CML treatment is an exclusion criteria with the following exception: While awaiting study start, patients may be treated with anagrelide (no treatment duration limit), hydroxyurea (no treatment duration limit), and/or up to a 14 day supply of a tyrosine kinase inhibitor (TKI) approved by the FDA for frontline treatment. Patients taking a TKI prior to study entry must have at least a one day washout from their last dose of medication and have recovered from any side effects of such therapy.
Impaired cardiac function as defined by the protocol. Patients with contraindications to receiving nilotinib, including concomitant medications.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01227577
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Contacts
| Contact: Novartis Pharmaceuticals | +1(800)340-6843 |
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| United States, Arkansas | |
| Hematology Oncology Services of Arkansas Dept. of HOSA | Not yet recruiting |
| Little Rock, Arkansas, United States, 72205 | |
| Contact 501-320-3217 | |
| Principal Investigator: Brad Baltz | |
| United States, California | |
| Pacific Cancer Medical Center, Inc. | Recruiting |
| Anaheim, California, United States, 92801 | |
| Contact 714-999-1465 | |
| Principal Investigator: Ajit S Maniam | |
| Providence St. Joseph Medical Center Roy&Patricia Disney Fam Cancer | Recruiting |
| Burbank, California, United States, 91505-6866 | |
| Contact 818-847-3211 | |
| Principal Investigator: Peter Rosen | |
| Bay Area Cancer Research Dept.ofBayAreaCancerResearch | Recruiting |
| Concord, California, United States, 94520 | |
| Contact 925-932-9700 | |
| Principal Investigator: Robert Robles | |
| Compassionate Cancer Care Medical Group CCCMG | Not yet recruiting |
| Fountain Valley, California, United States, 92708 | |
| Contact 714-698-0300 | |
| Principal Investigator: An Nguyen | |
| Compassionate Cancer Care Medical Group Dept.ofCCCMG-Riverside | Not yet recruiting |
| Fountain Valley, California, United States, 92708 | |
| Contact 951-276-2760 | |
| Principal Investigator: Brian Choi | |
| Redwood Regional Medical Group - Santa Rosa | Not yet recruiting |
| Santa Rosa, California, United States, 94503 | |
| Contact 707-525-3930 | |
| Principal Investigator: Marek Bozdech | |
| The Oncology Institute of Hope and Innovation | Not yet recruiting |
| Whitter, California, United States, 90606 | |
| Contact 562-698-6888 | |
| Principal Investigator: Merrill Shum | |
| St. Jude Heritage Medical Group Virginia Crosson Cancer Center | Recruiting |
| Yorba Linda, California, United States, 92886 | |
| Contact 714-446-5900 | |
| Principal Investigator: William Lawler | |
| United States, Colorado | |
| University of Colorado Colorado Univ | Not yet recruiting |
| Aurora, Colorado, United States, 80045 | |
| Contact 720-848-0655 | |
| Principal Investigator: Jonathan Gutman | |
| Denver Health Medical Center CACZ885M2301 | Not yet recruiting |
| Denver, Colorado, United States, 80204-4507 | |
| Contact 303-436-7431 | |
| Principal Investigator: Michael McLaughlin | |
| United States, Florida | |
| Cancer Care of North Florida, P.A. Cancer Care - Lake City, FL (2 | Not yet recruiting |
| Lake City, Florida, United States, 32024 | |
| Principal Investigator: Waseem Khan | |
| Advanced Medical Specialties | Recruiting |
| Miami, Florida, United States, 33176 | |
| Contact 305-595-2141 | |
| Principal Investigator: Lisa Reale | |
| Pasco Hernando Oncology | Not yet recruiting |
| New Port Richey, Florida, United States, 34652 | |
| Contact 813-842-2795 | |
| Principal Investigator: K.S. Kumar | |
| United States, Georgia | |
| Georgia Health Sciences University MedCollege of GA Cancer Ctr 2 | Not yet recruiting |
| Augusta, Georgia, United States, 30912 | |
| Contact 706-721-2505 | |
| Principal Investigator: Anand Jillella | |
| United States, Illinois | |
| Stroger Cook County Hospital Division of Hematology & Onc | Recruiting |
| Chicago, Illinois, United States, 60612 | |
| Contact 312-864-7257 | |
| Principal Investigator: Rosalind Catchatourian | |
| Louis A. Weiss Memorial Hospital | Not yet recruiting |
| Chicago, Illinois, United States, 60640 | |
| Contact 773-554-5020 | |
| Principal Investigator: Stuart Krauss | |
| Rush-Presbyterian St. Luke's Medical Center | Not yet recruiting |
| Chicago, Illinois, United States, 60612 | |
| Contact 312-942-5689 | |
| Principal Investigator: Jamile Shammo | |
| Northwest Oncology & Hematology Cancer Institute | Not yet recruiting |
| Elk Grove Village, Illinois, United States, 60007 | |
| Contact 847-437-3312 | |
| Principal Investigator: Bruce Bank | |
| United States, Indiana | |
| Indiana Blood and Marrow Institute | Recruiting |
| Beach Grove, Indiana, United States, 46107 | |
| Contact 317-782-6254 | |
| Principal Investigator: Luke P. Akard | |
| United States, Kansas | |
| Cancer Center of Kansas | Recruiting |
| Witchita, Kansas, United States, 67214-3728 | |
| Contact 316-262-4467 | |
| Principal Investigator: Shaker R. Dakhil | |
| United States, Louisiana | |
| Cabrini Center for Cancer Care | Not yet recruiting |
| Alexandria, Louisiana, United States, 71301 | |
| Contact 318-448-6917 | |
| Principal Investigator: Steven Saccaro | |
| LSU HEALTH SCIENCES CENTER/ LSU SCHOOL OF MEDICINE Feist-Weiller Cancer Center(3) | Recruiting |
| New Orleans, Louisiana, United States, 70115 | |
| Contact 318-813-1410 | |
| Principal Investigator: Nebu Koshy | |
| United States, Maryland | |
| U of Maryland | Recruiting |
| Baltimore, Maryland, United States, 21201 | |
| Contact 410-328-6635 | |
| Principal Investigator: Maria Baer | |
| St. Agnes Hospital Dept.ofSt.AgnesHospital | Not yet recruiting |
| Baltimore, Maryland, United States, 21229 | |
| Contact 410-368-2966 | |
| Principal Investigator: Carole Miller | |
| United States, Massachusetts | |
| Dana Farber Cancer Institute | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact 617-632-3902 | |
| Principal Investigator: Martha Wadleigh | |
| United States, Michigan | |
| Henry Ford Hospital | Recruiting |
| Detroit, Michigan, United States, 48202 | |
| Contact 313-556-8186 | |
| Principal Investigator: Philip Kuriakose | |
| United States, Missouri | |
| St. Louis University Cancer Center | Recruiting |
| St. Louis, Missouri, United States, 63110 | |
| Contact 314-268-7059 | |
| Principal Investigator: Steven Pincus | |
| United States, Nebraska | |
| University of Nebraska Medical Center University of Nebraska Med Ctr | Recruiting |
| Omaha, Nebraska, United States, 68198 | |
| Contact 402-559-6210 | |
| Principal Investigator: Lori Maness | |
| United States, New Jersey | |
| Hackensack University Medical Center Dept.of HackensackUniv.MedCtr. | Recruiting |
| Hackensack, New Jersey, United States, 07601 | |
| Principal Investigator: Stuart L. Goldberg | |
| St. Joseph's Regional Medical Center St. Joseph's Regional MC (3) | Not yet recruiting |
| Paterson, New Jersey, United States, 07503 | |
| Contact 862-591-2002 | |
| Principal Investigator: Michael Maroules | |
| United States, New York | |
| Montefiore Medical Center | Recruiting |
| Bronx, New York, United States, 10467 | |
| Contact 718-920-8146 | |
| Principal Investigator: Olga Derman | |
| U of Rochester Medical Ct James P Wilmot Cancer Ctr | Recruiting |
| Rochester, New York, United States, 14642 | |
| Contact 585-275-5830 | |
| Principal Investigator: Jane L. Liesveld | |
| SUNY at Stony Brook SUNY at Stony Brook 2 | Not yet recruiting |
| Stony Brook, New York, United States, 11794-8161 | |
| Contact 212-746-2119 | |
| Principal Investigator: Michael A. Schuster | |
| United States, North Carolina | |
| Duke University Medical Center Duke University Med Ctr | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Principal Investigator: David Moore | |
| United States, Ohio | |
| University Hospital University Hospital (2) | Not yet recruiting |
| Cincinnati, Ohio, United States, 45219-2316 | |
| Principal Investigator: Tahir Latif | |
| United States, Oregon | |
| Oregon Health & Science University | Recruiting |
| Portland, Oregon, United States, 97201 | |
| Contact 503-494-5630 | |
| Principal Investigator: Michael Mauro | |
| United States, Pennsylvania | |
| Penn State University / Milton S. Hershey Medical Center Penn Milton Hershey Ctr (2) | Not yet recruiting |
| Hershey, Pennsylvania, United States, 17033-085 | |
| Principal Investigator: David Claxton | |
| United States, South Carolina | |
| Cancer Centers of the Carolinas Cancer Center | Recruiting |
| Greenville, South Carolina, United States, 29605 | |
| Contact 864-241-6251 | |
| Principal Investigator: Suzanne Fanning | |
| United States, Tennessee | |
| Chattanooga Oncology and Hematology Assoicates, PC Memorial Plaza | Recruiting |
| Chattanooga, Tennessee, United States, 37404 | |
| Contact 423-698-1844 | |
| Principal Investigator: Edward R. Arrowsmith | |
| The Jones Clinic | Recruiting |
| Germantown, Tennessee, United States, 38138 | |
| Contact 901-685-5969 | |
| Principal Investigator: Michael C. Jones | |
| Tennessee Oncology Dept. of Centennial Medical | Recruiting |
| Nashville, Tennessee, United States, 37203 | |
| Contact 615-329-7252 | |
| Principal Investigator: Michael Savona | |
| United States, Texas | |
| Baylor Research Institute Baylor Research Institute (17) | Recruiting |
| Dallas, Texas, United States, 75204 | |
| Contact +1 214 820 9626 | |
| Principal Investigator: Moshe Yair Levy | |
| Northwest Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact 281-440-5006 | |
| Principal Investigator: Gressot Laurent | |
| Oncology Consultants Oncology Consultants, P.A. | Not yet recruiting |
| Houston, Texas, United States, 77024 | |
| Contact 713-827-9525 | |
| Principal Investigator: Luis T Campos | |
| United States, Virginia | |
| University of Virginia | Recruiting |
| Charlottesville, Virginia, United States, 22908 | |
| Contact 434-982-6399 | |
| Principal Investigator: Michael G. Douvas | |
| United States, Washington | |
| Providence Regional Cancer Partnership | Recruiting |
| Everett, Washington, United States, 98201 | |
| Contact 425-297-5532 | |
| Principal Investigator: James Congdon | |
| United States, West Virginia | |
| St. Mary's Medical Center | Not yet recruiting |
| Huntington, West Virginia, United States, 25702 | |
| Contact 304-528-4658 | |
| Principal Investigator: Avinder Bir | |
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT01227577 History of Changes |
| Other Study ID Numbers: | CAMN107AUS28 |
| Study First Received: | October 21, 2010 |
| Last Updated: | February 22, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Novartis:
|
CML Chronic Myelogenous Leukemia Leukemia CML-CP Nilotinib |
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 May 16, 2013