Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06530576
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-28
Brief Title:
Thalidomide for the Symptomatic Large Granular Lymphocytic Leukemia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Efficacy of Thalidomide for the Symptomatic Large Granular Lymphocytic Leukemia - a Prospective Phase Ⅱ Multicenter Clinical Trial From China
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
There is currently no standard first-line treatment for LGLL The investigators used the TPM regimen thalidomide prednison methotrexate to treat LGLL since 2020 enrolling a total of 54 patients and achieving an overall response rate ORR of 889 and a complete response CR rate of 759 To further explore this hypothesis the investigators designed this study to observe the efficacy of thalidomide monotherapy in patients with symptomatic LGLL The investigators speculate that thalidomide plays a major role in the significant improvement of the TPM regimen compared to the MTX regimen
Patients with LGLL are treated with thalidomide at 50 to 100 mg If the desired response is not achieved at specific time points methotrexate is added Thalidomide monotherapy is administered for up to 3 courses and the TM regimen can also be used for up to 3 courses The overall response rate with thalidomide monotherapy serves as the primary study endpoint
Patients with LGLL are treated with thalidomide at 50 to 100 mg If the desired response is not achieved at specific time points methotrexate is added Thalidomide monotherapy is administered for up to 3 courses and the TM regimen can also be used for up to 3 courses The overall response rate with thalidomide monotherapy serves as the primary study endpoint
Detailed Description:
The regimen is an oral treatment with a cycle of 4 months All patients first receive monotherapy with thalidomide at a dose of 50-100 mgQN After 4 months the efficacy is evaluated If effective the monotherapy continues for another 4 months If complete remission CR is achieved the treatment is consolidated for another 4 months before stopping for a total of 3 courses If CR is achieved at any point within the first year the treatment is consolidated for one more course and then stopped If partial remission PR is not achieved within the first cycle or CR is not achieved within the second cycle methotrexate 10 mgm2 orally once a weekis a is dded for consolidation with each cycle lasting 4 months After a maximum of 3 cycles treatment is stopped Patients who do not achieve PR after 2 cycles of the TM regimen will be withdrawn from the study with a maximum of 3 cycles allowed
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