Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00354822
Status:
TERMINATED
Last Update Posted:
2009-09-18
First Post:
2006-07-19
Brief Title:
FludarabineCyclophosphamide and Rituximab Followed by Zevalin for Non-Follicular Indolent Lymphomas
Sponsor:
AO Ospedale Papa Giovanni XXIII
Organization:
AO Ospedale Papa Giovanni XXIII
Study Overview
Official Title:
Phase II Study for Use of Oral Fludarabine Plus Cyclophosphamide and Rituximab Followed by Zevalin as Front-Line Treatment for Non-Follicular Indolent Lymphomas
Status:
TERMINATED
Status Verified Date:
2009-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Inability to recruit in time a sufficient number of patients
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Z0105
Brief Summary:
Pilot multicentre open label study with the aim to evaluate antitumor activity in term of the sum of complete and partial response ORR of chemotherapy cyclophosphamide and fludarabine and rituximab followed by zevalin radioimmunotherapy and response duration Time to relapse or progressionand to evaluate the safety of the treatment as acute and late toxicity
Secondary objective is to evaluate the overall survival OS and the event-free survival EFS
Secondary objective is to evaluate the overall survival OS and the event-free survival EFS
Detailed Description:
Test medication
Yttrium-90 90Y ibritumomab tiuxetan 04 mCikg is delivered to patient achieving at least a partial remission PR after chemotherapy as a single dose for patients with baseline platelet counts150x109L or 03 mCikg for patients with baseline platelet counts of 100 to 149x109L Rituximab 250mgsqm is given prior to therapeutic radiolabeled antibodies
Standard dose chemotherapy consisting of cyclophosphamide fludarabine and rituximab given every 28 days up to the best response maximum 6 courses
A prophylaxis for pneumocystis carinii as well as for herpes zoster are needed during treatment
Main parameters of activity activity of Yttrium-90 90Y ibritumomab tiuxetan after cyclophosphamide fludarabine and rituximab combination
Yttrium-90 90Y ibritumomab tiuxetan 04 mCikg is delivered to patient achieving at least a partial remission PR after chemotherapy as a single dose for patients with baseline platelet counts150x109L or 03 mCikg for patients with baseline platelet counts of 100 to 149x109L Rituximab 250mgsqm is given prior to therapeutic radiolabeled antibodies
Standard dose chemotherapy consisting of cyclophosphamide fludarabine and rituximab given every 28 days up to the best response maximum 6 courses
A prophylaxis for pneumocystis carinii as well as for herpes zoster are needed during treatment
Main parameters of activity activity of Yttrium-90 90Y ibritumomab tiuxetan after cyclophosphamide fludarabine and rituximab combination
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