Ignite Creation Date:
2024-05-05 @ 9:20 PM
Last Modification Date:
2024-10-26 @ 10:03 AM
Study NCT ID:
NCT00869999
Status:
COMPLETED
Last Update Posted:
2014-10-27
First Post:
2009-03-25
Brief Title:
Everolimus Plus Rituximab for RelapsedRefractory Diffuse Large B Cell Lymphoma
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Everolimus in Combination With Rituximab for RelapsedRefractory Diffuse Large B Cell Lymphoma
Status:
COMPLETED
Status Verified Date:
2013-10
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:
Everolimus is an oral mTOR inhibitor with demonstrated preliminary efficacy and safety in diffuse large B-cell lymphoma DLBCL in both preclinical and clinical studies The purpose of this research study is to determine whether Everolimus plus rituximab is safe and effective in participants with relapsed or refractory DLBCL Everolimus is an investigational drug that works by blocking a special protein that helps cancer cells grow The safety and effectiveness of Everolimus in the treatment of DLBCL has not yet been fully determined and is still investigational The other drug in this study rituximab is approved by the US Food and Drug Administration FDA for use in patients who have diffuse large B-cell lymphoma and certain other types of non-Hodgkin lymphoma Rituximab is a drug that destroys both normal and cancerous B-cells
Detailed Description:
Participants will receive oral Everolimus and intravenous rituximab for DLBCL that has relapsed or been refractory to prior therapy
Each treatment cycle lasts 28 days 4 weeks Everolimus will be taken orally once daily in the morning
Rituximab will be administered by an intravenous IV infusion on Days 1 8 15 and 22 of Cycle 1 In Cycles 2-6 rituximab will be administered only on Day 1 of each cycle
Participants will come into the clinic weekly during the first cycle then on Day 1 of all cycles thereafter The following tests and procedures will be performed
Weekly During Cycle 1 blood tests
Day 1 of all Subsequent Cycles brief physical examination review of current medications treatments symptoms and side effects vital signs performance status evaluation blood tests
A full body CT and PET scan to assess the participants tumor will be done within 7 days of completing cycles 2 4 6 9 and 12
Responding subjects may receive up to 6 cycles of Everolimus plus rituximab and an additional 6 months of oral Everolimus for participants continuing to respond
Each treatment cycle lasts 28 days 4 weeks Everolimus will be taken orally once daily in the morning
Rituximab will be administered by an intravenous IV infusion on Days 1 8 15 and 22 of Cycle 1 In Cycles 2-6 rituximab will be administered only on Day 1 of each cycle
Participants will come into the clinic weekly during the first cycle then on Day 1 of all cycles thereafter The following tests and procedures will be performed
Weekly During Cycle 1 blood tests
Day 1 of all Subsequent Cycles brief physical examination review of current medications treatments symptoms and side effects vital signs performance status evaluation blood tests
A full body CT and PET scan to assess the participants tumor will be done within 7 days of completing cycles 2 4 6 9 and 12
Responding subjects may receive up to 6 cycles of Everolimus plus rituximab and an additional 6 months of oral Everolimus for participants continuing to respond
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