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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

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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 ScottsdaleScottsdale, Arizona  85259
Mayo Clinic - JacksonvilleJacksonville, Florida  32224
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Hurley Medical CenterFlint, Michigan  48503
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
CCOP - Carle Cancer CenterUrbana, Illinois  61801
Veterans Affairs Medical Center - East OrangeEast Orange, New Jersey  07018-1095
Aurora Presbyterian HospitalAurora, Colorado  80012
Boulder Community HospitalBoulder, Colorado  80301-9019
Penrose Cancer Center at Penrose HospitalColorado Springs, Colorado  80933
CCOP - Colorado Cancer Research ProgramDenver, Colorado  80224-2522
Porter Adventist HospitalDenver, Colorado  80210
Presbyterian - St. Luke's Medical CenterDenver, Colorado  80218
St. Joseph HospitalDenver, Colorado  80218
Rose Medical CenterDenver, Colorado  80220
Swedish Medical CenterEnglewood, Colorado  80110
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical CenterGrand Junction, Colorado  81502
Sky Ridge Medical CenterLone Tree, Colorado  80124
Hope Cancer Care Center at Longmont United HospitalLongmont, Colorado  80502
St. Mary - Corwin Regional Medical CenterPueblo, Colorado  81004
North Suburban Medical CenterThornton, Colorado  80229
Rush-Copley Cancer Care CenterAurora, Illinois  60507
Evanston Northwestern Healthcare - Evanston HospitalEvanston, Illinois  60201-1781
Joliet Oncology-Hematology Associates, Limited - WestJoliet, Illinois  60435
Carle Cancer Center at Carle Foundation HospitalUrbana, Illinois  61801
Saint Anthony Memorial Health CentersMichigan City, Indiana  46360
Mercy Medical Center - Sioux CitySioux City, Iowa  51104
Siouxland Hematology-Oncology Associates, LLPSioux City, Iowa  51101
St. Luke's Regional Medical CenterSioux City, Iowa  51104
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
Saint Joseph Mercy Cancer CenterAnn Arbor, Michigan  48106-0995
Oakwood Cancer Center at Oakwood Hospital and Medical CenterDearborn, Michigan  48123-2500
Genesys Hurley Cancer InstituteFlint, Michigan  48503
Van Elslander Cancer Center at St. John Hospital and Medical CenterGrosse Pointe Woods, Michigan  48236
Foote HospitalJackson, Michigan  49201
Bronson Methodist HospitalKalamazoo, Michigan  49007
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Borgess Medical CenterKalamazooaa, Michigan  49001
Sparrow Regional Cancer CenterLansing, Michigan  48912-1811
Seton Cancer Institute - SaginawSaginaw, Michigan  48601
St. John Macomb HospitalWarren, Michigan  48093
Geisinger Medical CenterDanville, Pennsylvania  17822-0001
Penn State Cancer Institute at Milton S. Hershey Medical CenterHershey, Pennsylvania  17033-0850
Geisinger Medical Group - Scenery ParkState College, Pennsylvania  16801
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical CenterWilkes-Barre, Pennsylvania  18711
Sanford Cancer Center at Sanford USD Medical CenterSioux Falls, South Dakota  57117-5039
Medical X-Ray Center, PCSioux Falls, South Dakota  57105
Avera Cancer InstituteSioux Falls, South Dakota  57105
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical CenterLa Crosse, Wisconsin  54601
University of Wisconsin Paul P. Carbone Comprehensive Cancer CenterMadison, Wisconsin  53792-6164
Marshfield Clinic - Marshfield CenterMarshfield, Wisconsin  54449
Marshfield Clinic - Indianhead CenterRice Lake, Wisconsin  54868
Methodist Medical Center of IllinoisPeoria, Illinois  61636
Wesley Medical CenterWichita, Kansas  67214
Winship Cancer Institute of Emory UniversityAtlanta, Georgia  30322
Albert Einstein Cancer Center at Albert Einstein College of MedicineBronx, New York  10461
Lewistown HospitalLewistown, Pennsylvania  17044
Mount Nittany Medical CenterState College, Pennsylvania  16803
Swedish-American Regional Cancer CenterRockford, Illinois  61104-2315
Indiana University Melvin and Bren Simon Cancer CenterIndianapolis, Indiana  46202-5289
Decatur Memorial Hospital Cancer Care InstituteDecatur, Illinois  62526
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital MarltonMarlton, New Jersey  08053
Fox Chase Virtua Health Cancer Program at Virtua West JerseyVoorhees, New Jersey  08043
Graham HospitalCanton, Illinois  61520
Memorial HospitalCarthage, Illinois  62321
Eureka Community HospitalEureka, Illinois  61530
Galesburg Cottage HospitalGalesburg, Illinois  61401
Mason District HospitalHavana, Illinois  62644
Hopedale Medical ComplexHopedale, Illinois  61747
Kewanee HospitalKewanee, Illinois  61443
McDonough District HospitalMacomb, Illinois  61455
BroMenn Regional Medical CenterNormal, Illinois  61761
Community Cancer CenterNormal, Illinois  61761
Community Hospital of OttawaOttawa, Illinois  61350
Oncology Hematology Associates of Central Illinois, PC - OttawaOttawa, Illinois  61350
Cancer Treatment Center at Pekin HospitalPekin, Illinois  61554
Oncology Hematology Associates of Central Illinois, PC - PeoriaPeoria, Illinois  61615
Proctor HospitalPeoria, Illinois  61614
Illinois Valley Community HospitalPeru, Illinois  61354
Perry Memorial HospitalPrinceton, Illinois  61356
St. Margaret's HospitalSpring Valley, Illinois  61362
Exempla Lutheran Medical CenterWheat Ridge, Colorado  80033
William N. Wishard Memorial HospitalIndianapolis, Indiana  46202
McFarland Clinic, PCAmes, Iowa  50010
McGlinn Family Regional Cancer Center at Reading Hospital and Medical CenterReading, Pennsylvania  19612-6052
Regional Cancer Center at Memorial Medical CenterSpringfield, Illinois  62781-0001
Galesburg Clinic, PCGalesburg, Illinois  61401
Alexian Brothers Radiation OncologyElk Grove Village, Illinois  60007
California Cancer Care, Incorporated - GreenbraeGreenbrae, California  94904