Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

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.

Further Study Information

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.

Eligibility 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Eastern Cooperative Oncology Group

Ayalew Tefferi

Study Chair

Larry D. Cripe

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00227591
Information obtained from ClinicalTrials.gov on December 14, 2011

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