Ignite Creation Date:
2024-05-05 @ 4:35 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00278265
Status:
TERMINATED
Last Update Posted:
2016-10-03
First Post:
2006-01-16
Brief Title:
Methotrexate Followed by Fludarabine in Patients With T-Cell Large Granular Lymphocytic Leukemia
Sponsor:
German CLL Study Group
Organization:
German CLL Study Group
Study Overview
Official Title:
First Line Therapy With Methotrexate MTX and Second Line Therapy With Fludarabine of Patients With T-Cell Large Granular Lymphocyte Leukemia T-LGL
Status:
TERMINATED
Status Verified Date:
2016-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
slow recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy such as methotrexate and fludarabine work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing
PURPOSE This phase II trial is studying how well methotrexate works as first-line therapy and fludarabine works as second-line therapy in treating patients with T-cell large granular lymphocytic leukemia
PURPOSE This phase II trial is studying how well methotrexate works as first-line therapy and fludarabine works as second-line therapy in treating patients with T-cell large granular lymphocytic leukemia
Detailed Description:
OBJECTIVES
Primary
Determine remission rates and duration of remission in patients with T-cell large granular lymphocytic T-LGL leukemia needing intervention because of anemia or neutropenia and are treated with parenteral methotrexate MTX as first-line therapy
Determine remission rate and duration of remission in patients who fail to respond to MTX therapy and are subsequently treated with fludarabine as second-line therapy
Secondary
Determine the side effects of these drugs in these patients
Determine the rate of molecular remissions in patients treated with these drugs
OUTLINE This is a nonrandomized open-label multicenter study
Patients receive methotrexate subcutaneously once weekly in the absence of disease progression or unacceptable toxicity Patients not achieving a response to methotrexate receive fludarabine IV on days 1-3 Treatment with fludarabine repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study
Primary
Determine remission rates and duration of remission in patients with T-cell large granular lymphocytic T-LGL leukemia needing intervention because of anemia or neutropenia and are treated with parenteral methotrexate MTX as first-line therapy
Determine remission rate and duration of remission in patients who fail to respond to MTX therapy and are subsequently treated with fludarabine as second-line therapy
Secondary
Determine the side effects of these drugs in these patients
Determine the rate of molecular remissions in patients treated with these drugs
OUTLINE This is a nonrandomized open-label multicenter study
Patients receive methotrexate subcutaneously once weekly in the absence of disease progression or unacceptable toxicity Patients not achieving a response to methotrexate receive fludarabine IV on days 1-3 Treatment with fludarabine repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study
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 |
|---|---|---|---|
| CDR0000454596 | OTHER | Clinical Data Repository | None |
| GCLLSG-LGL1 | None | None | None |
| EU-20564 | None | None | None |