Lenalidomide and Prednisone in Treating Patients With Myelofibrosis

Condition(s) targeted: Chronic Myeloproliferative Disorders

Intervention: lenalidomide (Drug); prednisone (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: Eastern Cooperative Oncology Group

Official(s) and/or principal investigator(s):
Ayalew Tefferi, MD, Study Chair, Affiliation: Mayo Clinic
Larry D. Cripe, MD, Affiliation: Indiana University Melvin and Bren Simon Cancer Center

RATIONALE: Lenalidomide may stop the growth of myelofibrosis by blocking blood flow to the cancer. It may also stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide together with prednisone may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving lenalidomide together with prednisone works in treating patients with myelofibrosis.

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

Study design: Treatment, Open Label

Primary outcome: Overall response monthly

Secondary outcome: Duration of response

Detailed description: 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.

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

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

Rambam Medical Center, Haifa, Israel

Mayo Clinic Scottsdale, Scottsdale, Arizona 85259-5499, United States

California Cancer Care, Incorporated - Greenbrae, Greenbrae, California 94904, United States

Aurora Presbyterian Hospital, Aurora, Colorado 80012, United States

Boulder Community Hospital, Boulder, Colorado 80301-9019, United States

CCOP - Colorado Cancer Research Program, Denver, Colorado 80224-2522, United States

Exempla Lutheran Medical Center, Wheat Ridge, Colorado 80033, United States

Hope Cancer Care Center at Longmont United Hospital, Longmont, Colorado 80502, United States

North Suburban Medical Center, Thornton, Colorado 80229, United States

Penrose Cancer Center at Penrose Hospital, Colorado Springs, Colorado 80933, United States

Porter Adventist Hospital, Denver, Colorado 80210, United States

Presbyterian - St. Luke's Medical Center, Denver, Colorado 80218, United States

Rose Medical Center, Denver, Colorado 80220, United States

Sky Ridge Medical Center, Lone Tree, Colorado 80124, United States

St. Joseph Hospital, Denver, Colorado 80218, United States

St. Mary - Corwin Regional Medical Center, Pueblo, Colorado 81004, United States

St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center, Grand Junction, Colorado 81502, United States

Swedish Medical Center, Englewood, Colorado 80110, United States

Mayo Clinic - Jacksonville, Jacksonville, Florida 32224, United States

Winship Cancer Institute of Emory University, Altanta, Georgia 30322, United States

Alexian Brothers Radiation Oncology, Elk Grove Village, Illinois 60007, United States

BroMenn Regional Medical Center, Normal, Illinois 61761, United States

Cancer Treatment Center at Pekin Hospital, Pekin, Illinois 61554, United States

Carle Cancer Center at Carle Foundation Hospital, Urbana, Illinois 61801, United States

CCOP - Carle Cancer Center, Urbana, Illinois 61801, United States

CCOP - Illinois Oncology Research Association, Peoria, Illinois 61615, United States

Community Cancer Center, Normal, Illinois 61761, United States

Community Hospital of Ottawa, Ottawa, Illinois 61350, United States

Decatur Memorial Hospital Cancer Care Institute, Decatur, Illinois 62526, United States

Eureka Community Hospital, Eureka, Illinois 61530, United States

Evanston Northwestern Healthcare - Evanston Hospital, Evanston, Illinois 60201-1781, United States

Galesburg Clinic, PC, Galesburg, Illinois 61401, United States

Galesburg Cottage Hospital, Galesburg, Illinois 61401, United States

Graham Hospital, Canton, Illinois 61520, United States

Hopedale Medical Complex, Hopedale, Illinois 61747, United States

Illinois Valley Community Hospital, Peru, Illinois 61354, United States

Joliet Oncology-Hematology Associates, Limited - West, Joliet, Illinois 60435, United States

Kewanee Hospital, Kewanee, Illinois 61443, United States

Mason District Hospital, Havana, Illinois 62644, United States

McDonough District Hospital, Macomb, Illinois 61455, United States

Memorial Hospital, Carthage, Illinois 62321, United States

Methodist Medical Center of Illinois, Peoria, Illinois 61636, United States

Oncology Hematology Associates of Central Illinois, PC - Ottawa, Ottawa, Illinois 61350, United States

Oncology Hematology Associates of Central Illinois, PC - Peoria, Peoria, Illinois 61615, United States

Perry Memorial Hospital, Princeton, Illinois 61356, United States

Proctor Hospital, Peoria, Illinois 61614, United States

Regional Cancer Center at Memorial Medical Center, Springfield, Illinois 62781-0001, United States

Rush-Copley Cancer Care Center, Aurora, Illinois 60507, United States

St. Margaret's Hospital, Spring Valley, Illinois 61362, United States

Swedish-American Regional Cancer Center, Rockford, Illinois 61104-2315, United States

Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, Indiana 46202-5289, United States

Saint Anthony Memorial Health Centers, Michigan City, Indiana 46360, United States

William N. Wishard Memorial Hospital, Indianapolis, Indiana 46202, United States

McFarland Clinic, PC, Ames, Iowa 50010, United States

Mercy Medical Center - Sioux City, Sioux City, Iowa 51104, United States

Siouxland Hematology-Oncology Associates, LLP, Sioux City, Iowa 51101, United States

St. Luke's Regional Medical Center, Sioux City, Iowa 51104, United States

Wesley Medical Center, Wichita, Kansas 67214, United States

Borgess Medical Center, Kalamazooaa, Michigan 49001, United States

Bronson Methodist Hospital, Kalamazoo, Michigan 49007, United States

CCOP - Michigan Cancer Research Consortium, Ann Arbor, Michigan 48106, United States

Foote Hospital, Jackson, Michigan 49201, United States

Genesys Hurley Cancer Institute, Flint, Michigan 48503, United States

Hurley Medical Center, Flint, Michigan 48503, United States

Oakwood Cancer Center at Oakwood Hospital and Medical Center, Dearborn, Michigan 48123-2500, United States

Saint Joseph Mercy Cancer Center, Ann Arbor, Michigan 48106-0995, United States

Seton Cancer Institute - Saginaw, Saginaw, Michigan 48601, United States

Sparrow Regional Cancer Center, Lansing, Michigan 48912-1811, United States

St. John Macomb Hospital, Warren, Michigan 48093, United States

Van Elslander Cancer Center at St. John Hospital and Medical Center, Grosse Pointe Woods, Michigan 48236, United States

West Michigan Cancer Center, Kalamazoo, Michigan 49007-3731, United States

Mayo Clinic Cancer Center, Rochester, Minnesota 55905, United States

Fox Chase Virtua Health Cancer Program at Virtua West Jersey, Voorhees, New Jersey 08043, United States

Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton, Marlton, New Jersey 08053, United States

Veterans Affairs Medical Center - East Orange, East Orange, New Jersey 07018-1095, United States

Albert Einstein Cancer Center at Albert Einstein College of Medicine, Bronx, New York 10461, United States

Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center, Wilkes-Barre, Pennsylvania 18711, United States

Geisinger Medical Center, Danville, Pennsylvania 17822-0001, United States

Geisinger Medical Group - Scenery Park, State College, Pennsylvania 16801, United States

Lewistown Hospital, Lewistown, Pennsylvania 17044, United States

McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center, Reading, Pennsylvania 19612-6052, United States

Mount Nittany Medical Center, State College, Pennsylvania 16803, United States

Penn State Cancer Institute at Milton S. Hershey Medical Center, Hershey, Pennsylvania 17033-0850, United States

Avera Cancer Institute, Sioux Falls, South Dakota 57105, United States

Medical X-Ray Center, PC, Sioux Falls, South Dakota 57105, United States

Sanford Cancer Center at Sanford USD Medical Center, Sioux Falls, South Dakota 57117-5039, United States

Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center, La Crosse, Wisconsin 54601, United States

Marshfield Clinic - Indianhead Center, Rice Lake, Wisconsin 54868, United States

Marshfield Clinic - Marshfield Center, Marshfield, Wisconsin 54449, United States

University of Wisconsin Paul P. Carbone Comprehensive Cancer Center, Madison, Wisconsin 53792-6164, United States

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: December 2005
Last updated: May 23, 2008