A Phase II Study of Lenalidomide (CC-5013) in Combination With Prednisone for the Treatment of Myelofibrosis With Myeloid Metaplasia
OBJECTIVES:
Primary
- Determine the rate of complete or partial remission in patients with myelofibrosis with
myeloid metaplasia treated with lenalidomide and prednisone.
Secondary
- Determine the toxic effects of this regimen in these patients.
- Determine the duration of response in patients treated with this regimen.
- Determine the effect of this regimen on bone marrow fibrosis, angiogenesis, and
cytogenetics in these patients.
OUTLINE: This is a multicenter study.
For courses 1 and 2, patients receive oral lenalidomide once daily and oral prednisone once
daily on days 1-28. For course 3, patients receive oral lenalidomide once daily on days 1-28
and oral prednisone once on days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, and 27.
Patients with stable or responding disease after course 3 receive oral lenalidomide alone
once daily on days 1-28 for courses 4-6. Treatment repeats every 28 days for up to 6 courses
in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 1 year and
then every 6 months for up to 5 years from study entry.
PROJECTED ACCRUAL: A total of 41 patients will be accrued for this study within 11 months.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Overall response monthly
No
Ayalew Tefferi, MD
Study Chair
Mayo Clinic
United States: Food and Drug Administration
CDR0000442403
NCT00227591
December 2005
Name | Location |
---|---|
Mayo Clinic Scottsdale | Scottsdale, Arizona 85259 |
Mayo Clinic - Jacksonville | Jacksonville, Florida 32224 |
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
Hurley Medical Center | Flint, Michigan 48503 |
CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
Veterans Affairs Medical Center - East Orange | East Orange, New Jersey 07018-1095 |
Aurora Presbyterian Hospital | Aurora, Colorado 80012 |
Boulder Community Hospital | Boulder, Colorado 80301-9019 |
Penrose Cancer Center at Penrose Hospital | Colorado Springs, Colorado 80933 |
CCOP - Colorado Cancer Research Program | Denver, Colorado 80224-2522 |
Porter Adventist Hospital | Denver, Colorado 80210 |
Presbyterian - St. Luke's Medical Center | Denver, Colorado 80218 |
St. Joseph Hospital | Denver, Colorado 80218 |
Rose Medical Center | Denver, Colorado 80220 |
Swedish Medical Center | Englewood, Colorado 80110 |
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center | Grand Junction, Colorado 81502 |
Sky Ridge Medical Center | Lone Tree, Colorado 80124 |
Hope Cancer Care Center at Longmont United Hospital | Longmont, Colorado 80502 |
St. Mary - Corwin Regional Medical Center | Pueblo, Colorado 81004 |
North Suburban Medical Center | Thornton, Colorado 80229 |
Rush-Copley Cancer Care Center | Aurora, Illinois 60507 |
Evanston Northwestern Healthcare - Evanston Hospital | Evanston, Illinois 60201-1781 |
Joliet Oncology-Hematology Associates, Limited - West | Joliet, Illinois 60435 |
Carle Cancer Center at Carle Foundation Hospital | Urbana, Illinois 61801 |
Saint Anthony Memorial Health Centers | Michigan City, Indiana 46360 |
Mercy Medical Center - Sioux City | Sioux City, Iowa 51104 |
Siouxland Hematology-Oncology Associates, LLP | Sioux City, Iowa 51101 |
St. Luke's Regional Medical Center | Sioux City, Iowa 51104 |
CCOP - Michigan Cancer Research Consortium | Ann Arbor, Michigan 48106 |
Saint Joseph Mercy Cancer Center | Ann Arbor, Michigan 48106-0995 |
Oakwood Cancer Center at Oakwood Hospital and Medical Center | Dearborn, Michigan 48123-2500 |
Genesys Hurley Cancer Institute | Flint, Michigan 48503 |
Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods, Michigan 48236 |
Foote Hospital | Jackson, Michigan 49201 |
Bronson Methodist Hospital | Kalamazoo, Michigan 49007 |
West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
Borgess Medical Center | Kalamazooaa, Michigan 49001 |
Sparrow Regional Cancer Center | Lansing, Michigan 48912-1811 |
Seton Cancer Institute - Saginaw | Saginaw, Michigan 48601 |
St. John Macomb Hospital | Warren, Michigan 48093 |
Geisinger Medical Center | Danville, Pennsylvania 17822-0001 |
Penn State Cancer Institute at Milton S. Hershey Medical Center | Hershey, Pennsylvania 17033-0850 |
Geisinger Medical Group - Scenery Park | State College, Pennsylvania 16801 |
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center | Wilkes-Barre, Pennsylvania 18711 |
Sanford Cancer Center at Sanford USD Medical Center | Sioux Falls, South Dakota 57117-5039 |
Medical X-Ray Center, PC | Sioux Falls, South Dakota 57105 |
Avera Cancer Institute | Sioux Falls, South Dakota 57105 |
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center | La Crosse, Wisconsin 54601 |
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | Madison, Wisconsin 53792-6164 |
Marshfield Clinic - Marshfield Center | Marshfield, Wisconsin 54449 |
Marshfield Clinic - Indianhead Center | Rice Lake, Wisconsin 54868 |
Methodist Medical Center of Illinois | Peoria, Illinois 61636 |
Wesley Medical Center | Wichita, Kansas 67214 |
Winship Cancer Institute of Emory University | Atlanta, Georgia 30322 |
Albert Einstein Cancer Center at Albert Einstein College of Medicine | Bronx, New York 10461 |
Lewistown Hospital | Lewistown, Pennsylvania 17044 |
Mount Nittany Medical Center | State College, Pennsylvania 16803 |
Swedish-American Regional Cancer Center | Rockford, Illinois 61104-2315 |
Indiana University Melvin and Bren Simon Cancer Center | Indianapolis, Indiana 46202-5289 |
Decatur Memorial Hospital Cancer Care Institute | Decatur, Illinois 62526 |
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton | Marlton, New Jersey 08053 |
Fox Chase Virtua Health Cancer Program at Virtua West Jersey | Voorhees, New Jersey 08043 |
Graham Hospital | Canton, Illinois 61520 |
Memorial Hospital | Carthage, Illinois 62321 |
Eureka Community Hospital | Eureka, Illinois 61530 |
Galesburg Cottage Hospital | Galesburg, Illinois 61401 |
Mason District Hospital | Havana, Illinois 62644 |
Hopedale Medical Complex | Hopedale, Illinois 61747 |
Kewanee Hospital | Kewanee, Illinois 61443 |
McDonough District Hospital | Macomb, Illinois 61455 |
BroMenn Regional Medical Center | Normal, Illinois 61761 |
Community Cancer Center | Normal, Illinois 61761 |
Community Hospital of Ottawa | Ottawa, Illinois 61350 |
Oncology Hematology Associates of Central Illinois, PC - Ottawa | Ottawa, Illinois 61350 |
Cancer Treatment Center at Pekin Hospital | Pekin, Illinois 61554 |
Oncology Hematology Associates of Central Illinois, PC - Peoria | Peoria, Illinois 61615 |
Proctor Hospital | Peoria, Illinois 61614 |
Illinois Valley Community Hospital | Peru, Illinois 61354 |
Perry Memorial Hospital | Princeton, Illinois 61356 |
St. Margaret's Hospital | Spring Valley, Illinois 61362 |
Exempla Lutheran Medical Center | Wheat Ridge, Colorado 80033 |
William N. Wishard Memorial Hospital | Indianapolis, Indiana 46202 |
McFarland Clinic, PC | Ames, Iowa 50010 |
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center | Reading, Pennsylvania 19612-6052 |
Regional Cancer Center at Memorial Medical Center | Springfield, Illinois 62781-0001 |
Galesburg Clinic, PC | Galesburg, Illinois 61401 |
Alexian Brothers Radiation Oncology | Elk Grove Village, Illinois 60007 |
California Cancer Care, Incorporated - Greenbrae | Greenbrae, California 94904 |