Ignite Creation Date:
2024-05-05 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00287261
Status:
COMPLETED
Last Update Posted:
2014-12-09
First Post:
2006-02-02
Brief Title:
A Trial of Zoledronic Acid in Patients With Myelofibrosis With Myeloid Metaplasia MMM
Sponsor:
Universitaire Ziekenhuizen KU Leuven
Organization:
Universitaire Ziekenhuizen KU Leuven
Study Overview
Official Title:
A Prospective Multicentre Phase II Trial of Zoledronic Acid in Patients With Myelofibrosis With Myeloid Metaplasia MMM
Status:
COMPLETED
Status Verified Date:
2014-12
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:
In this trial the question is addressed if zoledronic acid Zometa Novartis Pharmacould be of clinical benefit for patients with myelofibrosis and myeloid metaplasia MMM
Detailed Description:
This is a prospective multicentre phase II study in adult patients with documented MMM and requiring therapy for their disease Patients will be treated every 3 weeks with 4 mg zoledronic acid Zometa administered by a 15 min intravenous infusion Study duration is 36 weeks 12 infusions After the study it is recommended to continue treatment until disease progression or the occurrence of unacceptable treatment-related toxicity
Objectives of the trial are
Primary objectives the effect of monthly infusion of zoledronic acid 4 mg on
hemoglobin level spleen size
Secondary objectives the effect of monthly infusion of zoledronic acid 4 mg on red blood cell transfusion need performance status constitutional symptoms leukocyte count thrombocyte count bone marrow fibrosis serum LDH
Objectives of the trial are
Primary objectives the effect of monthly infusion of zoledronic acid 4 mg on
hemoglobin level spleen size
Secondary objectives the effect of monthly infusion of zoledronic acid 4 mg on red blood cell transfusion need performance status constitutional symptoms leukocyte count thrombocyte count bone marrow fibrosis serum LDH
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