Ignite Creation Date:
2024-05-05 @ 5:03 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00377052
Status:
COMPLETED
Last Update Posted:
2023-08-04
First Post:
2006-09-13
Brief Title:
Bortezomib and Gemcitabine in Treating Patients With Relapsed Mantle Cell Lymphoma
Sponsor:
NCIC Clinical Trials Group
Organization:
Canadian Cancer Trials Group
Study Overview
Official Title:
A Phase II Study of Bortezomib and Gemcitabine in Patients With Relapsed Mantle Cell Lymphoma
Status:
COMPLETED
Status Verified Date:
2020-04
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:
RATIONALE Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer Drugs used in chemotherapy such as gemcitabine work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing Bortezomib may help gemcitabine work better by making cancer cells more sensitive to the drug
PURPOSE This phase II trial is studying how well giving bortezomib together with gemcitabine works in treating patients with relapsed mantle cell lymphoma
PURPOSE This phase II trial is studying how well giving bortezomib together with gemcitabine works in treating patients with relapsed mantle cell lymphoma
Detailed Description:
OBJECTIVES
Determine the efficacy response rate of bortezomib and gemcitabine hydrochloride in patients with relapsed mantle cell lymphoma
Determine the toxicity of this regimen in these patients
Determine the time to progression and duration of response in patients treated with this regimen
OUTLINE This is a nonrandomized multicenter study
Patients receive bortezomib IV on days 1 4 8 and 11 and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed at 4 weeks and then every 3 months thereafter until relapseprogression
Determine the efficacy response rate of bortezomib and gemcitabine hydrochloride in patients with relapsed mantle cell lymphoma
Determine the toxicity of this regimen in these patients
Determine the time to progression and duration of response in patients treated with this regimen
OUTLINE This is a nonrandomized multicenter study
Patients receive bortezomib IV on days 1 4 8 and 11 and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed at 4 weeks and then every 3 months thereafter until relapseprogression
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| B9E-CA-0485 | OTHER | Lilly | None |
| CAN-NCIC-IND172 | REGISTRY | None | None |
| ORTHO-CAN-NCIC-IND172 | OTHER | None | None |
| CDR0000493021 | OTHER | None | None |