Clinical trial · Interventional
Lenalidomide and Rituximab in Treating Patients With Non-Hodgkin Lymphoma
A Phase II Trial of the Combination of Lenalidomide and Rituximab in Patients With Relapsed/Refractory Follicular NHL (RV 0163)
NCT00848328CI-TRIAL-00088853terminatedPhase 2ClinicalTrials.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): Poor accrual
Summary
Brief summary (as posted)
RATIONALE: Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving lenalidomide together with rituximab may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving lenalidomide together with rituximab works in treating patients with follicular or small lymphocytic non-Hodgkin lymphoma that has relapsed or not responded to treatment.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lenalidomide | Drug | Lenalidomide | ALIAS |
| Rituximab | Biological | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Lenalidomide and Rituximab
- description
- Rituximab 375 mg/m2/wk x 4 weeks, to begin Cycle 1, Day 15. Lenalidomide 20 mg daily, days 1-21 of a 28 day cycle, to begin Day 1 of cycle 1 and continue until disease progression.
- interventionNames
- Biological: Rituximab
- Drug: Lenalidomide
Primary outcomes (1)
- measure
- Response, as defined by complete response (CR), near CR, partial response, or stable disease at 4 months
- timeFrame
- 4 months
- description
- Responses will be assessed by the Revised Working Group Response Criteria for Malignant Lymphoma. A complete response is the complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. A partial response is regression of measurable disease and no new sites of disease. Stable disease is failure to attain a complete response/partial response or progressive disease.
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically\* confirmed non-Hodgkin lymphoma, including one of the following subtypes:
* Grade 1, 2, or 3a (\> 15 centroblasts per high-power field with centrocytes present) follicular lymphoma according to WHO criteria
* Small lymphocytic lymphoma
* NOTE: \*Bone marrow biopsies as the sole means of diagnosis are not acceptable, but they may be submitted in conjunction with nodal biopsies or extra-nodal biopsies; fine-needle aspirates are not acceptable for diagnosis.
* At least one measurable lesion according to RECIST criteria
* Measurable lymphadenopathy to follow with serial exam and/or imaging
* Relapsed or refractory disease
* Must have evidence of disease progression during or after last treatment
* If previously treated with rituximab, must have disease progression within 6 months of last therapy OR if there was a prior response to rituximab, rituximab must not have been given within the past 6 months
* No evidence of CNS metastases
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Life expectancy \> 3 months
* Absolute neutrophil count ≥ 1,000/mm³
* Platelet count ≥ 75,000/mm³
* Serum creatinine ≤ 2.0 mg/dL
* Total bilirubin ≤ 2.0 mg/dL
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective double method contraception for ≥ 28 days before, during, and for ≥ 28 days after completion of study therapy
* HIV negative
* Able to swallow lenalidomide
* Able to take aspirin (81 or 325 mg) daily or low molecular weight heparin as prophylactic anticoagulation
* No neuropathy ≥ grade 2
* No known active hepatitis A, B, or C
* No other malignancies within the past 5 years except treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast
* No serious medical condition, laboratory abnormality, or psychiatric illness that would preclude the patient from signing the informed consent form
* No condition, including the presence of laboratory abnormalities, that would preclude study participation or confound the ability to interpret study data
* No known hypersensitivity to thalidomide or rituximab
* No development of erythema nodosum, if characterized by a desquamating rash while taking thalidomide or similar drugs
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* At least 4 weeks since prior anticancer therapy, including radiotherapy, hormonal therapy, or surgery
* More than 28 days since prior experimental drug or therapy
* No prior lenalidomide
* No other concurrent anticancer agents or treatments, including radiotherapy or thalidomide
* No other concurrent investigational agents
* No concurrent sargramostim (GM-CSF)
* No other concurrent antilymphoma therapy, including steroids (except for the treatment of hypersensitivity reactions)References
Publications (0)
Data not yet available
No reference posted for this study.