High Dose Rituximab for Initial Treatment of Indolent B-Cell Lymphomas

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT00895661
Phase
PHASE2
Status
Completed

Conditions

  • B-cell Lymphoma
  • Indolent B-cell Lymphoma

Eligibility Criteria

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

Interventions

  • rituximab — DRUG
    Increased dose (750 mg/m2) intravenously for 4 weekly doses followed by maintenance dosing once every three months for up to 2 years. Maintenance dose is standard (375 mg/m2).

Study Details

The purpose of this clinical trial is to see if increased doses of rituximab are safe and effective for the initial treatment of indolent B-cell lymphomas. Rituximab (Rituxan) is a type of drug called an "antibody" that specifically targets B-cell lymphoma cells, and is approved by the FDA for the treatment of indolent B-cell non-hodgkin lymphomas and certain other types of non-hodgkin lymphomas. Standard doses currently used may not be achieving maximal efficacy. Higher doses have been shown to be safe in other clinical trials, and may offer superior efficacy to the current standard dose. This trial also employs intermittent maintenance doses of rituximab at the standard dose, which has been shown to prolong remissions and survival in patients with relapsed indolent B-cell lymphomas. This trial is designed to show that higher dose rituximab plus maintenance rituximab can achieve similarly good results to chemotherapy approaches, but without chemotherapy-related toxicity.

Key Dates

Start date
Jul 31, 2009
Status verified
May 2017
Primary completion
Oct 31, 2010
Completion
Aug 31, 2015

Study Design

Enrollment
40 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: rituximab
    single-arm, open-label, interventional

Primary Outcome Measure

Determine Complete Response Rate (CRR) of Increased Dose Rituximab in Indolent B-cell Lymphomas [ Time Frame: after a median number of 8 maintenance cycles, up to 24 weeks ]

Locations (2)

FacilityCityStateZIPSite coordinators
Dana-Farber Cancer InstituteBostonMassachusetts02115-
Massachusetts General HospitalBostonMassachusetts02114-

Find similar trials in Boston, MA

By research site
Dana-Farber Cancer Institute· Boston, MAMassachusetts General Hospital· Boston, MA

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