Last reviewed · How we verify
Lenalidomide and Rituximab in Treating Patients With Previously Untreated Stage II, Stage III, or Stage IV Follicular Non-Hodgkin Lymphoma
Phase 2 trial testing Laboratory Biomarker Analysis in Ann Arbor Stage II Grade 1 Contiguous Follicular Lymphoma in 66 participants. Completed in 15 January 2022.
| Lead sponsor | National Cancer Institute (NCI) |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 66 |
| Start date | 15 June 2010 |
| Primary completion | 31 December 2012 |
| Estimated completion | 15 January 2022 |
| Sites | 91 locations across United States |
National Cancer Institute (NCI)
18 and older, any sex, with Ann Arbor Stage II Grade 1 Contiguous Follicular Lymphoma or Ann Arbor Stage II Grade 1 Non-Contiguous Follicular Lymphoma. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Response is assessed by investigator according to International Working Group (IWG) criteria. Complete response requires disappearance of all evidence of disease.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Lenalidomide, Rituximab) | 47 |
Data will be summarized using frequency tables.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Lenalidomide, Rituximab) | 51 |
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Lenalidomide, Rituximab) | 24 |
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Lenalidomide, Rituximab) | 21 |
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Lenalidomide, Rituximab) | 1 |
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Lenalidomide, Rituximab) | 14 |
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Lenalidomide, Rituximab) | 6 |
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Lenalidomide, Rituximab) | 1 |
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Lenalidomide, Rituximab) | 7 |
Kaplan-Meier method will be used. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Lenalidomide, Rituximab) | 0.86 | 0.75 – 0.93 |
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Lenalidomide, Rituximab) | 0.81 | 0.69 – 0.89 |
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Lenalidomide, Rituximab) | 0.74 | 0.61 – 0.86 |
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Lenalidomide, Rituximab) | 0.72 | 0.58 – 0.82 |
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Lenalidomide, Rituximab) | 47 | |
| Treatment (Lenalidomide, Rituximab) | 15 | |
| Treatment (Lenalidomide, Rituximab) | 1 | |
| Treatment (Lenalidomide, Rituximab) | 2 |
Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Treatment (Lenalidomide, R… |
|---|---|---|
| Fatigue | General disorders | — |
| Lymphocyte count decreased | Investigations | — |
| White blood cell decreased | Investigations | — |
| Neutrophil count decreased | Investigations | — |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | — |
| Alanine aminotransferase increased | Investigations | — |
| Platelet count decreased | Investigations | — |
| Diarrhea | Gastrointestinal disorders | — |
| Hyperglycemia | Metabolism and nutrition disorders | — |
| Anemia | Blood and lymphatic system disorders | — |
| Infusion related reaction | Injury, poisoning and procedural complications | — |
| Aspartate aminotransferase increased | Investigations | — |
| Constipation | Gastrointestinal disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Edema limbs | General disorders | — |
| Hypocalcemia | Metabolism and nutrition disorders | — |
| Headache | Nervous system disorders | — |
| Upper respiratory infection | Infections and infestations | — |
| Alkaline phosphatase increased | Investigations | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — |
| Abdominal pain | Gastrointestinal disorders | — |
| Pain | General disorders | — |
| Peripheral sensory neuropathy | Nervous system disorders | — |
| Pruritus | Skin and subcutaneous tissue disorders | — |
| Myalgia | Musculoskeletal and connective tissue disorders | — |
| Anxiety | Psychiatric disorders | — |
| Insomnia | Psychiatric disorders | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — |
| Hypertension | Vascular disorders | — |
| Dyspepsia | Gastrointestinal disorders | — |
| Blood bilirubin increased | Investigations | — |
| Hypokalemia | Metabolism and nutrition disorders | — |
| Back pain | Musculoskeletal and connective tissue disorders | — |
| Skin and subcut tissue disord - Oth spec | Skin and subcutaneous tissue disorders | — |
| Hypoglycemia | Metabolism and nutrition disorders | — |
| Neck pain | Musculoskeletal and connective tissue disorders | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — |
| Dry skin | Skin and subcutaneous tissue disorders | — |
| Mucositis oral | Gastrointestinal disorders | — |
Data from ClinicalTrials.gov NCT01145495 adverse events section.
This phase II trial studies how well lenalidomide and rituximab work in treating patients with previously untreated stage II, stage III, or stage IV follicular non-Hodgkin lymphoma. Biological therapies, such as lenalidomide, may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Monoclonal antibodies, such as rituximab, may interfere with the ability of cancer cells to grow and spread. Giving lenalidomide together with rituximab may kill more cancer cells.
8 peer-reviewed publications reference this trial (live from Europe PMC):
Verify or expand the search:
Trials testing the same drug.
Currently open trials in the same condition.
Trials by the same sponsor.
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01145495.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing