Clinical trial · Interventional
Rituximab and Combination Chemotherapy in Treating Patients With Newly Diagnosed Waldenstrom's Macroglobulinemia
Phase II Pilot Study Of Rituximab Plus CHOP In Patients With Newly Diagnosed Waldenstrom's Macroglobulinemia
NCT00060346CI-TRIAL-00067695terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): slow accrual
Summary
Brief summary (as posted)
RATIONALE: Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Combining rituximab with combination chemotherapy may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving rituximab together with combination chemotherapy works in treating patients with newly diagnosed Waldenstrom's macroglobulinemia.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Doxorubicin | Drug | Doxorubicin | ALIAS |
| Prednisone | Drug | Prednisone | ALIAS |
| rituximab | Biological | Rituximab | ALIAS |
| Vincristine | Drug | Vincristine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Rituximab + CHOP
- description
- Rituximab 375 mg/m2 day 1 of a 21-day cycle, followed by: Cyclophosphamide 750 mg/m2 Doxorubicin 50 mg/m2 Vincristine 1.4 mg/m2 and Prednisone 100 mg/m2 daily
- interventionNames
- Biological: rituximab
- Drug: cyclophosphamide
- Drug: Doxorubicin
- Drug: Prednisone
- Drug: Vincristine
Primary outcomes (1)
- measure
- Objective Response to Treatment
- timeFrame
- 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
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
INCLUSION CRITERIA: * Diagnosis of Waldenstrom's macroglobulinemia confirmed by the presence of the following: * 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 catheterization: * 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 EXCLUSION CRITERIA: * 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
References
Publications (1)
- RESULTAbonour R, Zhang LA, Rajkumar V, et al.: Phase II pilot study of rituximab + CHOP in patients with newly diagnosed Waldenstroms macroglobulinemia, an Eastren Cooperative Oncology Group trial (study E1A02). [Abstract] Blood 110 (11): A-3616, 2007.