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Phase II Pilot Study Of Rituximab Plus CHOP In Patients With Newly Diagnosed Waldenstrom's Macroglobulinemia

Phase 2
18 Years
Not Enrolling

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Trial Information

Phase II Pilot Study Of Rituximab Plus CHOP In Patients With Newly Diagnosed Waldenstrom's Macroglobulinemia


- Determine the response rate of patients with newly diagnosed Waldenstrom's
macroglobulinemia treated with rituximab, cyclophosphamide, doxorubicin, vincristine,
and prednisone.

- Determine the associated toxic effects of this regimen, specifically the frequency of
febrile neutropenia, in these patients.

- Determine the progression-free survival of patients treated with this regimen.

- Correlate baseline cytogenetic features and gene expression profiles with response in
patients treated with this regimen.

OUTLINE: This is a pilot, multicenter study.

Patients receive rituximab intravenously (IV) over approximately 4 hours, cyclophosphamide
IV over 5-30 minutes, doxorubicin IV over 5-15 minutes, and vincristine IV over 1 minute on
day 1. Patients also receive oral prednisone on days 1-5. Treatment repeats every 21 days
for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually for 5 years.

ACTUAL ACCRUAL: A total of 16 patients were accrued for this study.

Inclusion Criteria


- Diagnosis of Waldenstrom's macroglobulinemia confirmed by the presence of the

- Bone marrow lymphoplasmacytosis with: > 10% lymphoplasmacytic cells OR
aggregates or sheets of one of the following: lymphocytes, plasma cells or
lymphoplasmacytic cells on the bone marrow biopsy (measured within 4 weeks prior
to registration)

- Measurable disease defined as a quantitative immunoglobulin M (IgM) monoclonal
protein of > 1,000 mg/dL obtained within 4 weeks prior to registration

- Cluster of differentiation 20 (CD20) positive stain of bone marrow or lymph node
samples obtained < 8 weeks prior to registration

- Impaired bone marrow function due to infiltration by lymphoplasmacytic lymphoma,
defined by 1 of the following:

- Hemoglobin no greater than 11 g/dL

- Serum viscosity level relative to water of at least 4.0 centipoise

- Absolute neutrophil count at least 1,000/mm^3

- Platelet count at least 75,000/mm^3

- Bilirubin no greater than 3.0 mg/dL

- Aspartate aminotransferase (AST) no greater than 3 times upper limit of normal

- Creatinine no greater than 3.0 mg/dL

- Age of 18 and over

- ECOG (Eastern Cooperative Oncology Group) performance status 0-1

- Must be symptomatic with 1 of the following:

- Clinically significant anemia (hemoglobin no greater than 11 g/dL)

- Bulky lymphadenopathy

- Symptoms attributable to hyperviscosity (e.g., nose bleeding, gingival bleeding,
or retinal hemorrhage)

- History of heart disease allowed only if 1 of the following is demonstrated by
echocardiography, multigated acquisition scan (MUGA), exercise MUGA, or coronary

- Ejection fraction of at least 45%

- Normal fractional shortening of the left ventricle

- Must have been tested for hepatitis B surface antigen within 2 weeks of registration

- Negative pregnancy test

- Fertile patients must use effective contraception


- Prior treatment for Waldenstrom's macroglobulinemia

- Prior anti-CD20 therapy

- Concurrent steroids exceeding 10 mg prednisone (or equivalent) per day

- Prior irradiation if less than 4 weeks had elapsed prior to registration and the date
of last treatment

- Prior anthracyclines

- Prior malignancy except curatively treated basal cell or squamous cell carcinoma of
the skin, carcinoma in situ of the cervix, or other cancer curatively treated with
surgery alone and from which patient has been disease free for at least 5 years

- Active heart disease

- Pregnant or nursing

- Myocardial infarction within the past 3 months

- Congestive heart failure

- Symptomatic ventricular arrhythmia

Type of Study:


Study Design:

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

Outcome Measure:

Objective Response to Treatment

Outcome Description:

Objective response assessed using standard myeloma response criteria. Objective response is defined as a > 50% reduction in the quantitative IgM or M-Spike levels from baseline levels. Response must be documented by two measurements separated by at least 3 weeks.

Outcome Time Frame:

Every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-5 years from study entry, every 12 months if patient is 6-10 years from study entry

Safety Issue:


Principal Investigator

Rafat Abonour, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Indiana University Melvin and Bren Simon Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

June 2004

Completion Date:

August 2012

Related Keywords:

  • Lymphoma
  • Waldenstrom macroglobulinemia
  • Rituximab
  • CHOP
  • Lymphoma
  • Waldenstrom Macroglobulinemia



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