Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00023881
Status:
TERMINATED
Last Update Posted:
2018-11-14
First Post:
2001-09-13
Brief Title:
Bortezomib in Treating Patients With Chronic Myelogenous Leukemia
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase II Study of a Proteasome Inhibitor PS-341 NSC 681239 in Chronic Myelogenous Leukemia CML in Chronic or Accelerated Phase
Status:
TERMINATED
Status Verified Date:
2018-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of efficacy
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die
PURPOSE Phase II trial to study the effectiveness of bortezomib in treating patients who have chronic myelogenous leukemia in chronic or accelerated phase
PURPOSE Phase II trial to study the effectiveness of bortezomib in treating patients who have chronic myelogenous leukemia in chronic or accelerated phase
Detailed Description:
OBJECTIVES
Determine the efficacy of bortezomib in terms of response rate duration of response and survival of patients with Philadelphia chromosome-positive chronic myelogenous leukemia in chronic or accelerated phase
Assess the toxicity of this drug in these patients
OUTLINE Patients receive bortezomib intravenous IV over 3-5 seconds twice weekly on weeks 1-2 Treatment repeats every 3 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 5-30 patients will be accrued for this study within 15-30 months
Determine the efficacy of bortezomib in terms of response rate duration of response and survival of patients with Philadelphia chromosome-positive chronic myelogenous leukemia in chronic or accelerated phase
Assess the toxicity of this drug in these patients
OUTLINE Patients receive bortezomib intravenous IV over 3-5 seconds twice weekly on weeks 1-2 Treatment repeats every 3 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 5-30 patients will be accrued for this study within 15-30 months
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 |
|---|---|---|---|
| DM00-274 | OTHER | UT MD Anderson Cancer Center | None |
| MDA-DM-00274 | None | None | None |
| NCI-1756 | None | None | None |