Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Lenalidomide and Prednisone in Treating Patients With Myelofibrosis

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	NCI	ECOG-E4903 E4903, NCT00227591

Objectives

Primary

1. Determine the rate of complete or partial remission in patients with myelofibrosis with myeloid metaplasia treated with lenalidomide and prednisone.

Secondary

1. Determine the toxic effects of this regimen in these patients.
2. Determine the duration of response in patients treated with this regimen.
3. Determine the effect of this regimen on bone marrow fibrosis, angiogenesis, and cytogenetics in these patients.

Entry 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

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

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count ≥ 1,000/mm³
• Platelet count ≥ 100,000/mm³
• 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

Expected Enrollment

A total of 41 patients will be accrued for this study within 11 months.

Outcomes

Overall response monthly

Duration of response

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.

Trial Contact Information

Trial Lead Organizations

Eastern Cooperative Oncology Group

Ayalew Tefferi, MD, Protocol chair		Ph: 507-284-2511
Larry Cripe, MD, Protocol co-chair		Ph: 317-278-0757; 888-600-4822 Email: lcripe@iupui.edu

Registry Information
Official Title		A Phase II Study of Lenalidomide (CC-5013) in Combination with Prednisone for the Treatment of Myelofibrosis with Myeloid Metaplasia
Trial Start Date		2005-12-02
Trial Completion Date		2012-03-09 (estimated)
Registered in ClinicalTrials.gov		NCT00227591
Date Submitted to PDQ		2005-07-29
Information Last Verified		2009-06-09
NCI Grant/Contract Number		CA21115

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