Thalidomide and Rituximab in Waldenstrom's Macroglobulinemia

Steven P. Treon, MD, PhD

Status and phase: Completed; Phase 2

Conditions: Waldenstrom's Macroglobulinemia; Lymphoplasmacytic Lymphoma

Treatments: Drug: Thalidomide; Drug: Rituximab

Study type: Interventional

Funder types: Other

Identifiers

NCT00142116

03-077

Details and patient eligibility

About

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.

Full description

• Patients will receive thalidomide(200mg) orally once daily for two weeks. If after two weeks of thalidomide, the patient is doing well the dose of thalidomide will increase (400mg) and they will remain on it for up to 50 additional weeks. The length of time a patient is on thalidomide will depend upon how they are responding to therapy.
• During the second week of the study patients will also begin receiving rituximab intravenously once weekly for 4 weeks, which may then be repeated 8 weeks later depending upon the response.
• A determination of how the patient is responding will be made based on testing conducted at 12 weeks. This testing includes blood tests and possibly a bone marrow biopsy. If it is determined that the disease is not progressing, patients will begin a second phase of treatment which includes 4 additional weekly infusions of rituximab and the continuation of oral thalidomide.
• If it is determined at the 12-week evaluation, or at any time thereafter, that the disease has progressed (by studying serum immunoglobulin M (IgM) levels, bone marrow involvement, tumor cells, and/or development of new signs and symptoms) then the patient will be removed from the study.
• Periodic examinations and tests will be done to determine how the patient is doing, what response and side effects (if any) the patient may be having from the study drugs. If patient is responding to therapy then they will remain on this study and followed for a period of two years.
• Bone marrow biopsies and aspirations will be obtained at 3-6 month intervals extending for 2 years following the last treatment.

Enrollment: 25 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Thalidomide and Rituximab

Experimental group

Description:

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.

Treatment:

Drug: Rituximab

Drug: Thalidomide