Ignite Creation Date:
2024-05-05 @ 10:49 PM
Last Modification Date:
2024-10-26 @ 10:24 AM
Study NCT ID:
NCT01198665
Status:
COMPLETED
Last Update Posted:
2015-03-03
First Post:
2010-09-08
Brief Title:
RAD001 Combined With CHOP in Newly Diagnosed Peripheral T-cell Lymphomas
Sponsor:
Samsung Medical Center
Organization:
Samsung Medical Center
Study Overview
Official Title:
A Phase III Study of RAD001 Combined With CHOP in Newly Diagnosed Peripheral T-cell Lymphomas
Status:
COMPLETED
Status Verified Date:
2015-03
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:
RADCHOP
Brief Summary:
The urgent need for new effective therapy for T-cell lymphoma patients and promising results observed so far in trials with RAD001everolimus mTOR inhibitor strongly warrants the investigation of RAD001 combined with CHOP as a first-line treatment in peripheral T-cell lymphoma patients
Thus we designed a phase III study with the combination of RAD001 with CHOP chemotherapy for newly diagnosed peripheral T-cell lymphoma patients
Phase I
1 Primary objective
To define the maximum tolerable dose
2 Secondary objective
To evaluate the dose-limiting toxicity
To evaluate the pharmacokinetics of RAD001
Pharmacogenomic profiling
Phase II
1 Primary objective
To evaluate the overall response rate
2 Secondary objective
To estimate the time to progression
To estimate overall survival
Pharmacogenomic profiling
Thus we designed a phase III study with the combination of RAD001 with CHOP chemotherapy for newly diagnosed peripheral T-cell lymphoma patients
Phase I
1 Primary objective
To define the maximum tolerable dose
2 Secondary objective
To evaluate the dose-limiting toxicity
To evaluate the pharmacokinetics of RAD001
Pharmacogenomic profiling
Phase II
1 Primary objective
To evaluate the overall response rate
2 Secondary objective
To estimate the time to progression
To estimate overall survival
Pharmacogenomic profiling
Detailed Description:
Phase I Level 1 RAD001 25 mg PO daily D1-14 CHOP Level 2 RAD001 5 mg PO daily D1-14 CHOP Level 3 RAD001 75 mg PO daily D1-14 CHOP Level 4 RAD001 10 mg PO daily D1-14 CHOP CHOP every 3 weeks D1 Cytoxan 750mgm2 D5W 100ml MIV over 1hr D1 Doxorubicin 50mgm2 D5W 100ml MIV over 30mins D1 Vincristine 14mgm2 max2mg IV push D1-D5 Prednisolone 100mgd PO 40-30-30 Phase II Determined dosage of RAD001 CHOP every 3 weeks Treatment will be continued until planned 6 cycles or disease progression
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