Clinical trial · Interventional
CC-5013 (Lenalidomide) and Rituximab in Waldenstrom's Macroglobulinemia
Phase II Study of CC-5103 and Rituximab in Waldenstrom's Macroglobulinemia
NCT00142168CI-TRIAL-00021869terminatedPhase 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): Toxicity
Summary
Brief summary (as posted)
The purpose of this study is to determine the number of patients with Waldenstrom's macroglobulinemia that will benefit from treatment with CC-5103 (lenalidomide) and rituximab, what the side effects are and how long the benefit will last.
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 |
|---|---|---|---|
| Waldenstrom's Macroglobulinemia | Waldenstrom Macroglobulinemia | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CC-5103 (lenalidomide) | Drug | — | UNRESOLVED |
| Rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CC-5103 (Lenalidomide) and Rituximab
- description
- Intended therapy consisted of 48 weeks of CC-5103 (lenalidomide)(25 mg/d for 3 weeks and then 1 week off) along with rituximab (375 mg/m(2)/wk) dosed on weeks 2 to 5 and 13 to 16.
- interventionNames
- Drug: CC-5103 (lenalidomide)
- Drug: Rituximab
Primary outcomes (2)
- measure
- Time to Progression
- timeFrame
- 34.3 months
- description
- Time to progression is measured as the length in time in months from starting therapy until progression, defined as 25% increase in serum IgM from nadir.
- measure
- Overall Response
- timeFrame
- 34.3 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Clinicopathological diagnosis of Waldenstrom's macroglobulinemia using consensus panel criteria * Age 18 years or older * CD20 positive based on any previous bone marrow immunohistochemistry or flow cytometric analysis * All previous cancer therapy, including radiation, hormonal therapy and surgery, must have been discontinued at least 4 weeks prior to treatment in this study * Measurable disease, defined as presence of immunoglobulin M paraprotein with a minimum IgM level of equal to or greater than 2 times the upper limit of normal. * ECOG performance status of 0-2 * Absolute neutrophil count ≥ 100,000,000/L * Platelet count ≥ 50,000,000,000/L * Hemoglobin \> 8 g/dL * Serum creatinine \< 2.5 mg/dL * Total bilirubin \< 1.5 mg/dL * AST and ALT \< 2.5 x ULN * Disease free of prior malignancies fir 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix or breast Exclusion Criteria: * Any serious medical condition, laboratory abnormality, or psychiatric illness * Pregnant or lactating women * Prior therapy with rituximab or CC-5103 * Known hypersensitivity to thalidomide * Development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs. * Concurrent use of other anti-cancer agents or treatments
References
Publications (1)
- RESULTTreon SP, Soumerai JD, Branagan AR, Hunter ZR, Patterson CJ, Ioakimidis L, Chu L, Musto P, Baron AD, Nunnink JC, Kash JJ, Terjanian TO, Hyman PM, Nawfel EL, Sharon DJ, Munshi NC, Anderson KC. Lenalidomide and rituximab in Waldenstrom's macroglobulinemia. Clin Cancer Res. 2009 Jan 1;15(1):355-60. doi: 10.1158/1078-0432.CCR-08-0862. PMID 19118065