Ignite Creation Date:
2024-05-05 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00455910
Status:
COMPLETED
Last Update Posted:
2007-04-04
First Post:
2007-04-03
Brief Title:
Thalidomide at Low Dose for the Treatment of Patient With Myelodysplastic Syndromes - THAL-SMD-200
Sponsor:
Groupe Francophone des Myelodysplasies
Organization:
Groupe Francophone des Myelodysplasies
Study Overview
Official Title:
Thalidomide for the Treatment of Cytopenias of Patients With Low Risk Myelodysplastic Syndromes
Status:
COMPLETED
Status Verified Date:
2007-04
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:
The GFM previously conducted a dose-escalating phase II trial of thalidomide in MDS with a minimum dose of 200mgd and a maximum dose 800mgd Responses were evaluated according to IWG criteria at week 16 and thalidomide continued up to week 56 in responders 82 patients received at least 8 weeks of treatment and were evaluable 59 had hematological improvement mainly on the erythroid lineage Increase of Hemoglobin Most responses were observed at low doses and between 4 and 8 weeks
The objectives of this trial Thal-SMD-20 are to evaluate the efficacy and tolerance of lower doses thalidomide in low risk MDS patients with transfusion-dependant anemia
The objectives of this trial Thal-SMD-20 are to evaluate the efficacy and tolerance of lower doses thalidomide in low risk MDS patients with transfusion-dependant anemia
Detailed Description:
Thalidomide
First part of the trial 82 patients at 200mgday given at bedtime x 12 weeks decreased to 100mgday if grade 1 or 2 side Stopped temporally for 1 week if grade 3 or 4 side effects Then reintroduced at the same dose If side effects again definitively stopped
Responses evaluated at 12 weeks according to IWG criteria for the erythroid lineage
At week 12
If no Hematological improvement HI increased to 300mgday for 8 weeks and then eventually to 400mgday for 8 weeks more if no HI
If Hematological improvement HI continued at the same dose
Second part of the trial 30 patients treated at 50mgday x 12 weeks Responses evaluated at 12 weeks according to IWG criteria for the erythroid lineage
At week 12
If no Hematological improvement HI increased to 100mgday for 8 weeks and then eventually to 200mgday for 8 weeks more if no HI
If Hematological improvement HI continued at the same dose
First part of the trial 82 patients at 200mgday given at bedtime x 12 weeks decreased to 100mgday if grade 1 or 2 side Stopped temporally for 1 week if grade 3 or 4 side effects Then reintroduced at the same dose If side effects again definitively stopped
Responses evaluated at 12 weeks according to IWG criteria for the erythroid lineage
At week 12
If no Hematological improvement HI increased to 300mgday for 8 weeks and then eventually to 400mgday for 8 weeks more if no HI
If Hematological improvement HI continued at the same dose
Second part of the trial 30 patients treated at 50mgday x 12 weeks Responses evaluated at 12 weeks according to IWG criteria for the erythroid lineage
At week 12
If no Hematological improvement HI increased to 100mgday for 8 weeks and then eventually to 200mgday for 8 weeks more if no HI
If Hematological improvement HI continued at the same dose
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 |
|---|---|---|---|
| CCPPRB Cochin 2402-1-1928 | None | None | None |