CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 25 enrolled
Drug / intervention
Thalidomide +1 moredrug
Likely dose
Thalidomide 200 mg orally once daily for 14 weeks, escalated to 400 mg for up to 50 weeks if tolerated; Rituximab intravenously once weekly for 4 weeks (beginning week 2), repeatable at 8 weeks if toleratedAI-extracted
Key inclusion· 8
  • ✓Clinicopathological diagnosis of Waldenstrom's macroglobulinemia requiring therapy
  • ✓Age >18 years
  • ✓Life expectancy ≥3 months
  • ✓ECOG performance status 0-2
Key exclusion· 5
  • ✕Chemotherapy, steroid therapy, or radiation therapy within 30 days of study entry
  • ✕Pregnant or lactating women
  • ✕Serious co-morbid disease
  • ✕Uncontrolled bacterial, fungal, or viral infection

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00142116
NCT00142116Phase 2Completed
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Phase II Study of Thalidomide and Rituximab in Waldenstrom's Macroglobulinemia

Steven P. Treon, MD, PhD·interventional·Posted Sep 2, 2005·Updated Jun 2, 2014

In Brief

A Phase 2 clinical trial evaluating Thalidomide and Rituximab for Waldenstrom's Macroglobulinemia and Lymphoplasmacytic Lymphoma. Completed, enrolled 25 participants across 2 sites.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsWaldenstrom's Macroglobulinemia, Lymphoplasmacytic Lymphoma
CountriesUnited States
CollaboratorsDana-Farber Cancer Institute, Massachusetts General Hospital, Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Cape Cod Hospital

Timeline

Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 2, 2005
Enrollment StartMay 1, 2003
Primary CompletionFeb 1, 2004
Study CompletionFeb 1, 2008
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 20.8 years ago

Interventions

Thalidomidedrug

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.

Rituximabdrug

Given intravenously once weekly for 4 weeks beginning the second week of study treatment. If tolerated well, this may be repeated 8 weeks later.