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Phase II Study of Thalidomide and Rituximab in Waldenstrom's Macroglobulinemia

Phase 2
18 Years
80 Years
Open (Enrolling)
Waldenstrom's Macroglobulinemia, Lymphoplasmacytic Lymphoma

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Trial Information

Phase II Study of Thalidomide and Rituximab in Waldenstrom's Macroglobulinemia

- 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 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.

Inclusion Criteria:

- Clinicopathological diagnosis of Waldenstrom's macroglobulinemia requiring therapy

- Baseline staging requirements

- ANC > 500/uL

- PLT > 25,000/uL

- Serum creatinine < 2.5mg/dL

- Total bilirubin and SGOT < 2.5 X ULN

- Greater than 18 years of age

- Life expectancy of 3 months or greater

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To define objective response to time to treatment failure, and toxicity for combined thalidomide and rituximab therapy in Waldenstrom's macroglobulinemia patients.

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Steven P. Treon, MD, MA, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Institutional Review Board

Study ID:




Start Date:

May 2003

Completion Date:

February 2008

Related Keywords:

  • Waldenstrom's Macroglobulinemia
  • Lymphoplasmacytic Lymphoma
  • thalidomide
  • rituximab
  • Waldenstrom's
  • Lymphoma
  • Waldenstrom Macroglobulinemia



Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
Massachusetts General Hospital Boston, Massachusetts  02114-2617