Phase 2 N=25 Treatment

Thalidomide and Rituximab in Waldenstrom's Macroglobulinemia

Waldenstrom's Macroglobulinemia · Lymphoplasmacytic Lymphoma

Bottom Line

View on ClinicalTrials.gov: NCT00142116 ↗

Enrolled (actual)

Serious AEs

8.0%

Results posted

Jun 2014

Primary outcome: Primary: Objective Response Rate — 1; 15; 2; 7 participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Thalidomide (Drug); Rituximab (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Steven P. Treon, MD, PhD
Primary completion: Feb 2004

Outcome Measures

Outcome	Result	p-value
PRIMARY Objective Response Rate	1; 15; 2; 7	—
PRIMARY Time to Progression	34.8; 38.7; 15.25; 36.04	—
SECONDARY To Identify the Mechanism(s) of Action for Combined Thalidomide and Rituximab Activity.	—	—

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.

Eligibility Criteria

Inclusion Criteria

Clinicopathological diagnosis of Waldenstrom's macroglobulinemia requiring therapy
Baseline staging requirements
Absolute Neutrophil Count > 500/microliter (uL)
Platelet Count > 25,000/uL
Serum creatinine < 2.5mg/dL
Total bilirubin and transaminase (SGOT) < 2.5 X Upper Limit of Normal (ULN)
Greater than 18 years of age
Life expectancy of 3 months or greater
Eastern Cooperative Oncology Group (ECOG) status performance of 0-2

Exclusion Criteria

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
Active second malignancy

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00142116). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.