Lenalidomide and Prednisone in Treating Patients With Myelofibrosis
Recruitment status was Active, not recruiting
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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 2 |
| 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 |
- Overall response monthly [ Designated as safety issue: No ]
- Duration of response [ Designated as safety issue: No ]
| Estimated Enrollment: | 41 |
| Study Start Date: | December 2005 |
| Estimated Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
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| 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:
- 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
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
Additional Information:
No publications provided by Eastern Cooperative Oncology Group
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 |
Keywords provided by Eastern Cooperative Oncology Group:
|
chronic idiopathic myelofibrosis polycythemia vera essential thrombocythemia |
Additional relevant MeSH terms:
|
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 |
ClinicalTrials.gov processed this record on May 23, 2013