Progression Free Survival
Primary
· approximately 71 months
Will be calculated and corresponding 95% confidence interval (CI) will be derived.
| Group | Value | 95% CI |
|---|---|---|
| Single Arm | 70.7 | 65.8 – 76.1 |
Last reviewed · How we verify
NCT02871219
Obinutuzumab and Lenalidomide in Treating Patients With Previously Untreated Stage II-IV Grade 1-3a Follicular Lymphoma
Completed
Phase 2
Results posted
Last updated 8 June 2025
What this trial tests
Phase 2 trial testing Lenalidomide in Ann Arbor Stage II Grade 1 Follicular Lymphoma in 96 participants. Completed in 26 June 2024.
Timeline
6 December 2016
Primary endpoint
26 June 2024
26 June 2024
26 June 2024
Quick facts
| Lead sponsor | M.D. Anderson Cancer Center |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 96 |
| Start date | 6 December 2016 |
| Primary completion | 26 June 2024 |
| Estimated completion | 26 June 2024 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Lenalidomide — full drug profile →
- Obinutuzumab — full drug profile →
Conditions studied
- Ann Arbor Stage II Grade 1 Follicular Lymphoma — all drugs for Ann Arbor Stage II Grade 1 Follicular Lymphoma →
- Ann Arbor Stage II Grade 2 Follicular Lymphoma — all drugs for Ann Arbor Stage II Grade 2 Follicular Lymphoma →
- Ann Arbor Stage III Grade 1 Follicular Lymphoma — all drugs for Ann Arbor Stage III Grade 1 Follicular Lymphoma →
- Ann Arbor Stage III Grade 2 Follicular Lymphoma — all drugs for Ann Arbor Stage III Grade 2 Follicular Lymphoma →
Sponsor
M.D. Anderson Cancer Center — full company profile →
Who can join
18 and older, any sex, with Ann Arbor Stage II Grade 1 Follicular Lymphoma or Ann Arbor Stage II Grade 2 Follicular Lymphoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Complete Response
Secondary
· 24 months
The number and percentage of subjects will be tabulated.
| Group | Value | 95% CI |
|---|---|---|
| Single Arm | 96.6 | 90.4 – 99.3 |
Overall Response Rate (CR + Partial Response [PR])
Secondary
· 24 months
The number and percentage of subjects will be tabulated.
| Group | Value | 95% CI |
|---|---|---|
| Single Arm | 97.70 | 92.0 – 99.7 |
Duration of Response
Secondary
· From the time by which measurement criteria for CR or PR, whichever is recorded first, is met until death or the first date by which progressive disease is documented, assessed up to 3 years
Kaplan-Meier methodology will be used to estimate event-free curves, median, and 95% CI.
| Group | Value | 95% CI |
|---|---|---|
| Single Arm | NA | NA – NA |
Event Free Survival
Secondary
· From the date of course 1, day 1 to the date of first documented progression, transformation to diffuse large B-cell lymphoma, initiation of new anti-lymphoma treatment, or death, assessed up to 3 years
Kaplan-Meier methodology will be used to estimate event-free curves, median, and 95% CI.
| Group | Value | 95% CI |
|---|---|---|
| Single Arm | NA | NA – NA |
Overall Survival
Secondary
· From the date of course 1, day 1 to the date of death regardless of cause, assessed up to 3 years
Kaplan-Meier methodology will be used to estimate event-free curves, median, and 95% CI.
| Group | Value | 95% CI |
|---|---|---|
| Single Arm | NA | NA – NA |
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Single Arm
Serious: 55/90 (61%)
Deaths: 3/90
Serious adverse events (30 terms)
| Reaction | System | Single Arm |
|---|---|---|
| Diarrhea | Gastrointestinal disorders | — |
| Fatigue | Nervous system disorders | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — |
| Fever | Nervous system disorders | — |
| Headache | Nervous system disorders | — |
| Neutrophil count decreased | Blood and lymphatic system disorders | — |
| Investigations-Other | Investigations | — |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | — |
| Lung Infection (Pneumonia) | Respiratory, thoracic and mediastinal disorders | — |
| Urinary tract infection | Renal and urinary disorders | — |
| Hyperuricemia | Renal and urinary disorders | — |
| Colitis | General disorders | — |
| Blood and lymphatic systmem disorders-Other | Blood and lymphatic system disorders | — |
| Febrile Neutropenia | Blood and lymphatic system disorders | — |
| Hypercalcemia (Pain in extremity and hypercalcemia) | Vascular disorders | — |
| Infections and infestations-Other | Infections and infestations | — |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | — |
| Syncope | Vascular disorders | — |
| Treatment related secondary malignancy (Bladder Cancer) | Renal and urinary disorders | — |
| Colonic hemorrhage | Gastrointestinal disorders | — |
| Eye disorders-Other (Basal cell carcinoma (left eye rim) | Nervous system disorders | — |
| Hypotension | Vascular disorders | — |
| Investigation and-Other (Diverticulitis) | Investigations | — |
| Paroxysmal atrial tachcardia | Vascular disorders | — |
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | — |
Other adverse events (97 terms — click to expand)
| Reaction | System | Single Arm |
|---|---|---|
| Diarrhea | Gastrointestinal disorders | — |
| Constipation | Gastrointestinal disorders | — |
| Fatigue | Nervous system disorders | — |
| Myalgia | Musculoskeletal and connective tissue disorders | — |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — |
| Upper respiratory infection | Respiratory, thoracic and mediastinal disorders | — |
| Fever | General disorders | — |
| Headache | Nervous system disorders | — |
| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | — |
| Edema limbs | General disorders | — |
| Dizziness | Nervous system disorders | — |
| Lymphedema | Infections and infestations | — |
| Memory Impairment | Nervous system disorders | — |
| Blurred Vision | Nervous system disorders | — |
| Dry Skin | Skin and subcutaneous tissue disorders | — |
| Investigations-Other | Nervous system disorders | — |
| Abdominal Pain | Gastrointestinal disorders | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — |
| Drye Eye | General disorders | — |
| Insomnia | Nervous system disorders | — |
| Pruritus | Skin and subcutaneous tissue disorders | — |
| Anemia | Blood and lymphatic system disorders | — |
| Anorexia | Gastrointestinal disorders | — |
| Chills | Musculoskeletal and connective tissue disorders | — |
| Sinus bradycardia | Cardiac disorders | — |
| Skin and subcutaneous tissue disorders-Other | Skin and subcutaneous tissue disorders | — |
| Nasal Congestion | Blood and lymphatic system disorders | — |
| Peripheral sensory neuropathy | Nervous system disorders | — |
| Vomiting | General disorders | — |
| Back pain | Musculoskeletal and connective tissue disorders | — |
| Bloating | Gastrointestinal disorders | — |
| General disorders and administration site condtions-Other | General disorders | — |
| Infusion related reaction | General disorders | — |
| Lung Infection | Respiratory, thoracic and mediastinal disorders | — |
| Lymphocyte count decreased | Blood and lymphatic system disorders | — |
| Tremor | Nervous system disorders | — |
| Urinary tract infection | Renal and urinary disorders | — |
Most-reported serious reactions: Diarrhea, Fatigue, Cough, Fever, Headache, Neutrophil count decreased, Investigations-Other, Rash maculo-papular.
Data from ClinicalTrials.gov NCT02871219 adverse events section.
Sponsor's own description
This phase II trial studies how well obinutuzumab and lenalidomide work in treating patients with previously untreated stage II-IV grade 1-3a follicular lymphoma. Immunotherapy with obinutuzumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as lenalidomide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving obinutuzumab and lenalidomide may work better in treating patients with previously untreated follicular lymphoma.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Obinutuzumab in the treatment of B-cell malignancies: a comprehensive review.
Davies A, Kater AP, Sharman JP, Stilgenbauer S, et al · · 2022 · cited 23× · PMID 35856239 · DOI 10.2217/fon-2022-0112 -
Novel treatment approaches and future perspectives in follicular lymphoma.
Sutamtewagul G, Link BK. · · 2019 · cited 7× · PMID 30719267 · DOI 10.1177/2040620718820510 -
The clinical development of obinutuzumab for the treatment of follicular lymphoma.
Ma B, Ujjani C. · · 2017 · cited 2× · PMID 28435325 · DOI 10.2147/cmar.s114526 -
A phase 2 study of obinutuzumab combined with lenalidomide in previously untreated high tumor burden follicular lymphoma.
Akkad N, Feng L, Westin JR, Hagemeister FB, et al · · 2025 · PMID 40517417 · DOI 10.1182/bloodadvances.2025016483
Verify or expand the search:
- PubMed search for NCT02871219
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT02871219 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by M.D. Anderson Cancer Center
- Last refreshed: 8 June 2025
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/NCT02871219.
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