Know Cancer

or
forgot password

A Phase II Study of Lenalidomide (CC-5013) in Combination With Prednisone for the Treatment of Myelofibrosis With Myeloid Metaplasia


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Chronic Myeloproliferative Disorders

Thank you

Trial Information

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.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of myelofibrosis with myeloid metaplasia, including any of the following
subtypes:

- Agnogenic myeloid metaplasia

- Post-polycythemic myeloid metaplasia

- Post-thrombocythemic myeloid metaplasia

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-2

Life expectancy

- Not specified

Hematopoietic

- Absolute neutrophil count ≥ 1,000/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≤ 10 g/dL OR

- Transfusion dependent

Hepatic

- Total or direct bilirubin ≤ 2.0 mg/dL

- AST ≤ 3 times upper limit of normal (unless due to hepatic extramedullary
hematopoiesis)

- No hepatitis A, B, or C infection

Renal

- Creatinine ≤ 2.0 mg/dL

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No known HIV positivity

- No condition or laboratory abnormality that would preclude study participation

- No other active malignancy

- No known hypersensitivity to thalidomide or lenalidomide

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No prior lenalidomide

- At least 28 days since prior interferon alfa, thalidomide, or growth factors

- No concurrent growth factors

Chemotherapy

- At least 28 days since prior chemotherapy

- At least 28 days since prior hydroxyurea

Endocrine therapy

- At least 28 days since prior systemic corticosteroids

Radiotherapy

- Not specified

Surgery

- Not specified

Other

- Recovered from prior therapy

- At least 28 days since prior anagrelide or other myelosuppressive agents

- At least 28 days since prior experimental therapy

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response monthly

Safety Issue:

No

Principal Investigator

Ayalew Tefferi, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000442403

NCT ID:

NCT00227591

Start Date:

December 2005

Completion Date:

Related Keywords:

  • Chronic Myeloproliferative Disorders
  • chronic idiopathic myelofibrosis
  • polycythemia vera
  • essential thrombocythemia
  • Primary Myelofibrosis
  • Myeloproliferative Disorders

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