Ignite Creation Date:
2024-05-05 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00443339
Status:
UNKNOWN
Last Update Posted:
2007-05-17
First Post:
2007-03-04
Brief Title:
Darbepoetin Alpha in Myelodysplastic Syndromes MDS
Sponsor:
Groupe Francophone des Myelodysplasies
Organization:
Groupe Francophone des Myelodysplasies
Study Overview
Official Title:
A Phase II Study of Darbepoetin Alpha in Myelodysplastic Syndromes MSD
Status:
UNKNOWN
Status Verified Date:
2007-03
Last Known Status:
RECRUITING
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 is an evaluation of the effectiveness of darbepoetin alpha in treating anemia of MDS patients with an International Prognostic Scoring System IPSS score of low or intermediate 1
Detailed Description:
Inclusion of MDS with IPSS low or int-1 and hemoglobin 10dL
Study drug Darbepoetin alfa Aranesp 500 microg every two weeks subcutaneously during 12 weeks combined to filgrastim 300 microg twice weekly for an additional 12 weeks in non responders
Response will be evaluated at 12 weeks Patients with major or minor erythroid response HI-E major or minor according to IWG 2000 criteria will be continued on Aranesp In non-responders an additional 12 weeks of Aranesp at the same dosing combined to Filgrastim 300 ug twice weekly then adjusted to maintain WBC between 5000 and 10000mm3 will be proposed In case of response the treatment will be continued for a total duration of 24 months If Hb level reaches levels 13 gdl at any time Aranesp should be discontinued until Hb levels are less than 12 gdl Aranesp should then be resumed at 500 µginjection every 3 weeks Intervals between injections should be further increased by one week every time they lead to Hb levels 13 gdl The purpose of this dose adjustment is to reach the Aranesp schedule allowing a maintenance Hb level between 11 and 12 gdl
Study drug Darbepoetin alfa Aranesp 500 microg every two weeks subcutaneously during 12 weeks combined to filgrastim 300 microg twice weekly for an additional 12 weeks in non responders
Response will be evaluated at 12 weeks Patients with major or minor erythroid response HI-E major or minor according to IWG 2000 criteria will be continued on Aranesp In non-responders an additional 12 weeks of Aranesp at the same dosing combined to Filgrastim 300 ug twice weekly then adjusted to maintain WBC between 5000 and 10000mm3 will be proposed In case of response the treatment will be continued for a total duration of 24 months If Hb level reaches levels 13 gdl at any time Aranesp should be discontinued until Hb levels are less than 12 gdl Aranesp should then be resumed at 500 µginjection every 3 weeks Intervals between injections should be further increased by one week every time they lead to Hb levels 13 gdl The purpose of this dose adjustment is to reach the Aranesp schedule allowing a maintenance Hb level between 11 and 12 gdl
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