Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00227591
Status:
COMPLETED
Last Update Posted:
2014-05-21
First Post:
2005-09-26
Brief Title:
Lenalidomide and Prednisone in Treating Patients With Myelofibrosis
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of Lenalidomide CC-5013 in Combination With Prednisone for the Treatment of Myelofibrosis With Myeloid Metaplasia
Status:
COMPLETED
Status Verified Date:
2012-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II trial is studying how well giving lenalidomide together with prednisone works in treating patients with myelofibrosis 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
Detailed Description:
PRIMARY OBJECTIVES
I To evaluate the rate of complete or partial remission from treatment with a combination of lenalidomide and prednisone in patients with myelofibrosis with myeloid metaplasia
SECONDARY OBJECTIVES
I To examine drug toxicity II To examine duration of response III To examine the effect of treatment on bone marrow fibrosis angiogenesis and cytogenetics
OUTLINE
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
I To evaluate the rate of complete or partial remission from treatment with a combination of lenalidomide and prednisone in patients with myelofibrosis with myeloid metaplasia
SECONDARY OBJECTIVES
I To examine drug toxicity II To examine duration of response III To examine the effect of treatment on bone marrow fibrosis angiogenesis and cytogenetics
OUTLINE
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2012-02976 | REGISTRY | None | None |
| ECOG-E4903 | None | None | None |
| E4903 | OTHER | None | None |
| E4903 | OTHER | None | None |
| U10CA021115 | NIH | CTEP | httpsreporternihgovquickSearchU10CA021115 |