Everolimus Plus Rituximab for Relapsed/Refractory Diffuse Large B Cell Lymphoma

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT00869999
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Everolimus — DRUG
    Taken orally once daily in the morning
  • rituximab — DRUG
    Given intravenously on Days 1, 8, 15, and 22 of Cycle 1 then on Day 1 of cycles 2-6

Study Details

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.

Key Dates

Start date
May 31, 2009
Status verified
Oct 2013
Primary completion
Nov 30, 2011
Completion
Nov 30, 2011

Study Design

Enrollment
26 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Primary Outcome Measure

Overall Response Rate [ Time Frame: Assessed at the conclusion of cycle 2, cycle 4 and cycle 6 ]

Locations (2)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconsess Medical CenterBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02114-

Find similar trials in Boston, MA

By research site
Beth Israel Deaconsess Medical Center· Boston, MAMassachusetts General Hospital· Boston, MA

Related Studies