An Exploratory Trial to Assess the Improvement of Adverse Events in Chronic Myelogenous Leukemia Patients Treated With Imatinib When Switched to Nilotinib Treatment

Condition(s) targeted: Chronic Myelogenous Leukemia

Intervention: Nilotinib (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Novartis Pharmaceuticals

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals

The purpose of this exploratory study will be to examine changes in chronic low grade chronic adverse events, measured by Common Terminology Criteria for Adverse Events (CTCAE) grading, when patients are switched from imatinib to nilotinib therapy.

Official title: An Exploratory Trial to Assess the Improvement of Chronic Low-grade Non-hematologic Adverse Events Experienced by Patients With Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) Treated With Imatinib When Switched to Nilotinib Treatment

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Improvement of (CTCAE grading scale) of imatinib related chronic low grade non hematologic Adverse Event after switch to treatment with nilotinib at End of Cycle 3

Secondary outcome:

Rate of Complete Cytogenetic Response (CCyR) present at baseline

Rate of a Major Molecular Response (MMR) after the switch in the therapy

Magnitude of Bcr-Abl change after the switch in therapy

Durability of cytogenetic and molecular response

Time to optimal imatinib-related adverse event improvement

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

1. Male or female patients ≥ 18 years of age

2. ECOG 0, 1, or 2

3. Diagnosis of CML-CP associated with Bcr-Abl quantifiable by RQ-PCR (IS)

4. Patients must be an imatinib responder and achieved the following efficacy milestones as appropriate for the length of time on imatinib therapy as per protocol

5. CML-CP patients initiated on any dose of imatinib

6. Ability to provide written informed consent prior to any study related screening procedures being done

Exclusion Criteria:

1. Loss of CHR or cytogenetic response

2. Prior accelerated phase or blast phase CML

3. Previously documented T315I mutation

4. Presence of chromosomal abnormalities (trisomy 8) and/or clonal evolution other than Ph+.

5. Previous treatment with any other tyrosine kinase inhibitor except for imatinib.

6. Treatment with other investigational agents within 30 days of Day 1.

7. History of non-compliance to medical regimens or inability to grant consent.

8. Women who are pregnant, breast feeding, or of childbearing potential without a negative serum test at baseline. Male or female patients of childbearing potential unwilling to use contraceptive precautions throughout the trial and 3 months following discontinuation of study drug. Post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Women of childbearing potential must have a negative serum pregnancy test prior to the first dose of nilotinib.

Other protocol-defined inclusion/exclusion criteria may apply

Highlands Oncology Group, Fayetteville, Arkansas 72703, United States; Recruiting
Becky Ivy, Phone: 479-878-7025
Thaddeus Beck, M.D., Principal Investigator

Hematology Oncology Services of Arkansas, Little Rock, Arkansas 77205, United States; Recruiting
Priscilla Gray, Phone: 501-320-3223
Joanna Tucker, Phone: 501-907-6444
Brad Baltz, M.D., Principal Investigator

USC Norris Cancer Center/LAC USC Medical Center, Los Angeles, California 90033, United States; Recruiting
Nancy Berman, Phone: 323-865-3928
Yanderi Sandoval, Phone: 323-865-3879
Sikander Ailawadhi, M.D., Principal Investigator

Southwest Cancer Center, Murrieta, California 92563, United States; Recruiting
Mona Bilawa, Phone: 951-696-7632
Michael Kosmo, M.D., Principal Investigator

Rocky Mountain Cancer Centers, Aurora, Colorado 80013, United States; Recruiting
Mary Ridgen, Phone: 303-418-7639
John Burke, M.D., Principal Investigator

Florida Cancer Institute - New Hope, New Port Richey, Florida 34655, United States; Recruiting
Michelle Ellenwood, Phone: 727-842-8412
Gerald Robbins, M.D., Principal Investigator

Cancer Centers of Florida, Orlando, Florida 32807, United States; Recruiting
Lynn Hogue, Phone: 407-426-8485
Maria Flores, M.D., Principal Investigator

John H. Stroger Hospital of Cook County, Chicago, Illinois 60612, United States; Recruiting
Augustin Haidau, Phone: 312-864-7263
Rosalind Catchatourian, M.D., Principal Investigator

Indiana Blood and Marrow Transplantation, Beech Grove, Indiana 46107, United States; Recruiting
Elissa Knezevich, Phone: 317-782-7296
Luke Akard, M.D., Principal Investigator

Hematology Oncology of Indiana, PC, Indianapolis, Indiana 46260, United States; Recruiting
Lorene Cripe, Phone: 317-415-6631
Ruemu Birhiray, M.D., Principal Investigator

St. Agnes Hospital, Baltimore, Maryland 21229, United States; Recruiting
Elizabeth Chandler, Phone: 410-368-2966
Carole Miller, M.D., Principal Investigator

St Louis University, St. Louis, Missouri 63110, United States; Recruiting
Lynne Klipsch, Phone: 314-268-7059
Steven Pincus, M.D., Principal Investigator

Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada 89169, United States; Recruiting
Linda Cortes, Phone: 702-952-3400
Regan Holdridge, M.D., Principal Investigator

Hematology Oncology Associates of Northern NJ, Morristown, New Jersey 07962, United States; Recruiting
Michelle Mackenzie, Phone: 973-538-5211
Michael Scola, M.D., Principal Investigator

Interlakes Oncology Hematology, PC, Rochester, New York 14623, United States; Recruiting
Deborah Smith, Phone: 585-350-2300
Alexander Solky, M.D., Principal Investigator

Raleigh Hematology Oncology Associates, Raleigh, North Carolina 27608, United States; Recruiting
Dianne Bracco, Phone: 919-781-7071
William Berry, M.D., Principal Investigator

William Osler Health System - Brampton Civic Hos, Brampton, Ontario L6R 3J7, Canada; Recruiting
Mary Spiteri, Phone: +1-905 494 2120
Sandeep Sehdev, M.D., Principal Investigator

Princess Margaret Hospital, Toronto, Ontario M5G2M9, Canada; Recruiting
Lidia Casciaro, Phone: 416-946-2268
Jeffrey Lipton, M.D., Principal Investigator

Oregon Health and Science University, Portland, Oregon 97239, United States; Recruiting
Nan Subbiah, Phone: 503-494-4603
Alp Ozpinar
Michael Mauro, M.D., Principal Investigator

Mc Gill University Department of Oncology, Montreal, Quebec, Canada; Recruiting
Penny Chipman, Phone: 514-843-1558
Pierre Laneuville, Dr., Principal Investigator

Hospital Maisonneuve-Rosemont, Montreal, Quebec H1T2M4, Canada; Recruiting
MICHEL-OLIVIER GRATTON, Phone: 514-252-3400, Ext: 2397
Lambert Busque, M.D., Principal Investigator

The Jones Clinic, Germantown, Tennessee 38138, United States; Recruiting
Lori Lynch, Phone: 901-685-5969, Ext: 322
Clyde Jones, M.D., Principal Investigator

Texas Oncology-Bedford, Bedford, Texas 76022, United States; Recruiting
Cynthia Schoenfeldt, Phone: 817-359-9034
Thomas Anderson, M.D., Principal Investigator

Texas Oncology - Dallas Presbyterian Hospital, Dallas, Texas 75232, United States; Recruiting
Kaylene Smith, Phone: 214-793-4176
Kristi McIntyre, M.D., Principal Investigator

M.D. Anderson Cancer Center, Houston, Texas 77030, United States; Recruiting
Silvia Aldous, Phone: 713-792-1636
Jorge Cortes, M.D., Principal Investigator

Baylor College of Medicine, Houston, Texas 77030, United States; Recruiting
Amanda Wilborn, Phone: 713-798-4080
Martha Mims, M.D., Principal Investigator

Texas Oncology- Mesquite, Mesquite, Texas 75151, United States; Recruiting
Christie Stixrud, Phone: 972-686-6412
Sreenivas Chittoor, M.D., Principal Investigator

Cancer Centers of South Texas, San Antonio, Texas 78229, United States; Recruiting
Alice Bock, Phone: 210-595-5301
Gregory Guzley, M.D., Principal Investigator

Cancer Care Centers of South Texas, San Antonio, Texas 78217, United States; Recruiting
Elizabeth Guthrie, Phone: 210-656-7178
Sharon Wilks, M.D., Principal Investigator

Texas Oncology - Sugar Land, Sugar Land, Texas 77479, United States; Recruiting
Krisann Nething, Phone: 281-277-5200
Caesar Tin-U, M.D., Principal Investigator

Northwest Cancer Specialist, Vancouver, Washington 98686, United States; Recruiting
Judith Welch, Phone: 360-573-0472
Kathryn Kolibaba, M.D., Principal Investigator

Starting date: December 2009
Last updated: September 28, 2011