Ignite Creation Date:
2024-05-05 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00511069
Status:
COMPLETED
Last Update Posted:
2008-11-24
First Post:
2007-08-02
Brief Title:
Velcade Bortezomib - PS341 in the Treatment of Patients Over 18 Years With Ph Leukemia
Sponsor:
University of Bologna
Organization:
University of Bologna
Study Overview
Official Title:
A Phase II Study of Velcade Bortezomib - PS341 in the Treatment of Patients Over 18 Years With Ph Leukemia
Status:
COMPLETED
Status Verified Date:
2008-11
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:
Ph leukemias ieChronic Myelogenous Leukemia CML and Ph Acute Lymphoblastic Leukemia are malignant clonal disorder of the hemopoietic stem cell due to reciprocal translocation of genetic material between chromosome 9 and 22 giving rise to the translocation t922 q22 q21 The translocation causes the formation of a new hybrid gene bcr-abl that codes for a 185 kb or 210 kb cytoplasmic protein P185 and P210 respectively that by autophosphorylation activates a number of signaling pathways involved in cell proliferation maturation apoptosis and adhesion leading to the malignant cell transformation1-3 The course of the disease goes on through a chronic phase CP usually lasting some years that is characterized by a massive myeloid hyperplasia with hyperleukocytosis and splenomegaly The CP is almost always followed by an accelerated or blastic phase ABP where the leukemic process acquires the characteristics of acute leukemia The ABP usually lasts some months and terminates with the death of the patient3
The frequency of CML in western countries ranges between 10 and 15 per million persons age - standardized It is rare in children The median age is 55 years
Current treatment of CML includes conventional chemotherapy allogeneic bone marrow transplantation allo BMT alpha-interferon alpha-IFNand imatinib
The frequency of CML in western countries ranges between 10 and 15 per million persons age - standardized It is rare in children The median age is 55 years
Current treatment of CML includes conventional chemotherapy allogeneic bone marrow transplantation allo BMT alpha-interferon alpha-IFNand imatinib
Detailed Description:
None
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 |
|---|---|---|---|
| EUDRACT 2004-002977-22 | None | None | None |