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| Sponsor: | Eastern Cooperative Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | Eastern Cooperative Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00227591 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Myeloproliferative Disorders |
Drug: lenalidomide Drug: prednisone |
Phase II |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of Lenalidomide (CC-5013) in Combination With Prednisone for the Treatment of Myelofibrosis With Myeloid Metaplasia |
| Estimated Enrollment: | 41 |
| Study Start Date: | December 2005 |
| Estimated Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of myelofibrosis with myeloid metaplasia, including any of the following subtypes:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations
Show 90 Study Locations| Study Chair: | Ayalew Tefferi, MD | Mayo Clinic |
| Investigator: | Larry D. Cripe, MD | Indiana University Melvin and Bren Simon Cancer Center |
More Information
| Responsible Party: | Robert L. Comis, ECOG Group Chair's Office |
| ClinicalTrials.gov Identifier: | NCT00227591 History of Changes |
| Other Study ID Numbers: | CDR0000442403, U10CA021115, ECOG-E4903 |
| Study First Received: | September 26, 2005 |
| Last Updated: | June 21, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
chronic idiopathic myelofibrosis polycythemia vera essential thrombocythemia |
|
Primary Myelofibrosis Myeloproliferative Disorders Bone Marrow Diseases Hematologic Diseases Prednisone Lenalidomide Thalidomide Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents, Hormonal |
Antineoplastic Agents Therapeutic Uses Anti-Inflammatory Agents Immunosuppressive Agents Immunologic Factors Leprostatic Agents Anti-Bacterial Agents Anti-Infective Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors |