Thalidomide and Rituximab in Waldenstrom's Macroglobulinemia

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Steven P. Treon, MD, PhD
Study ID
NCT00142116
Phase
PHASE2
Status
Completed

Conditions

  • Lymphoplasmacytic Lymphoma
  • Waldenstrom's Macroglobulinemia

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Thalidomide — DRUG
    200mg orally once a day for 14 weeks if that dosage is tolerated well, it will be increased to 400mg for up to 50 weeks.
  • Rituximab — DRUG
    Given intravenously once weekly for 4 weeks beginning the second week of study treatment. If tolerated well, this may be repeated 8 weeks later.

Study Details

The purpose of this study is to determine the percentage of people who can attain remission and the length of time such responses to therapy are sustained, as well as the side effects that might result from rituximab and thalidomide in people with lymphoplasmacytic lymphoma.

Key Dates

Start date
May 31, 2003
Status verified
May 2014
Primary completion
Feb 29, 2004
Completion
Feb 29, 2008

Study Design

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

Arms

  • Experimental: Thalidomide and Rituximab
    Thalidomide 200mg orally once a day for 14 weeks if that dosage is tolerated well, it will be increased to 400mg for up to 50 weeks Rituximab Given intravenously once weekly for 4 weeks beginning the second week of study treatment. If tolerated well, this may be repeated 8 weeks later.

Primary Outcome Measure

Objective Response Rate [ Time Frame: 3 years ]

Locations (2)

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

Find similar trials in Boston, MA

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

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