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Pembrolizumab With Rituximab or Obinutuzumab in Treating Patients With Relapsed or Refractory Follicular Lymphoma or Diffuse Large B Cell Lymphoma
Phase 2 trial testing Laboratory Biomarker Analysis in Recurrent Diffuse Large B-Cell Lymphoma in 18 participants. Terminated before completion.
| Lead sponsor | University of Washington |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 18 |
| Start date | 23 March 2018 |
| Primary completion | 19 December 2023 |
| Estimated completion | 19 September 2024 |
| Sites | 1 location across United States |
University of Washington
18 and older, any sex, with Recurrent Diffuse Large B-Cell Lymphoma or Recurrent 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.
Will be defined as the rate of complete + partial responses using computed tomography (CT) criteria (Lugano 2014).
| Group | Value | 95% CI |
|---|---|---|
| Arm I Follicular Lymphoma (Pembrolizumab, Rituximab) | 29 | |
| Arm II DLBCL (Pembrolizumab, Rituximab) | 0 | |
| Arm III Follicular Lymphoma (Pembrolizumab, Obinutuzumab) | 0 |
Evaluated by the NCI Common Terminology for Adverse Events (CTCAE), version 4.0.
| Group | Value | 95% CI |
|---|---|---|
| Arm I Follicular Lymphoma (Pembrolizumab, Rituximab) | 100 | |
| Arm II DLBCL (Pembrolizumab, Rituximab) | 63 | |
| Arm III Follicular Lymphoma (Pembrolizumab, Obinutuzumab) | 67 |
The Kaplan-Meier method will be used to estimate median PFS.
| Group | Value | 95% CI |
|---|---|---|
| Arm I Follicular Lymphoma (Pembrolizumab, Rituximab) | 0.23 | 0.18 – NA |
| Arm II DLBCL (Pembrolizumab, Obinutuzumab) | 0.21 | 0.11 – NA |
| Arm III Follicular Lymphoma (Pembrolizumab, Obinutuzumab) | 0.50 | 0.38 – NA |
The Kaplan-Meier method will be used to estimate median OS.
| Group | Value | 95% CI |
|---|---|---|
| Arm I Follicular Lymphoma (Pembrolizumab, Rituximab) | NA | 3.1 – NA |
| Arm II DLBCL (Pembrolizumab, Obinutuzumab) | 1.5 | 0.65 – NA |
| Arm III Follicular Lymphoma (Pembrolizumab, Obinutuzumab) | NA | 1.1 – NA |
Time frame: Adverse events were recorded from the time of informed consent and for 90 days after the last dose of pembrolizumab.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Arm I Follicular Lymphoma … | Arm II DLBCL (Pembrolizuma… | Arm III Follicular Lymphom… |
|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | — | — | — |
| Hypokalemia | Metabolism and nutrition disorders | — | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — | — |
| Altered mental status | Psychiatric disorders | — | — | — |
| Fever | General disorders | — | — | — |
| Streptococcus salivarius | Infections and infestations | — | — | — |
| Heart Failure | Cardiac disorders | — | — | — |
| Hypercalcemia | Investigations | — | — | — |
| Pericarditis | Cardiac disorders | — | — | — |
| Pleurisy | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Pneumonia | Infections and infestations | — | — | — |
| Reaction | System | Arm I Follicular Lymphoma … | Arm II DLBCL (Pembrolizuma… | Arm III Follicular Lymphom… |
|---|---|---|---|---|
| Fatigue | Gastrointestinal disorders | — | — | — |
| Upper respiratory infection | Infections and infestations | — | — | — |
| Diarrhea | Gastrointestinal disorders | — | — | — |
| Infusion related reaction | General disorders | — | — | — |
| Anemia | Blood and lymphatic system disorders | — | — | — |
| Anorexia | Metabolism and nutrition disorders | — | — | — |
| Constipation | Gastrointestinal disorders | — | — | — |
| Creatinine Increased | Infections and infestations | — | — | — |
| Hyperthyroidism | Endocrine disorders | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — |
| Acute Kidney Injury | Renal and urinary disorders | — | — | — |
| Edema Limbs | General disorders | — | — | — |
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — | — |
| Back Pain | Musculoskeletal and connective tissue disorders | — | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Hypertension | Vascular disorders | — | — | — |
| Headache | Nervous system disorders | — | — | — |
| Pneumonia | Infections and infestations | — | — | — |
| Dizziness | Nervous system disorders | — | — | — |
| Night sweats | Gastrointestinal disorders | — | — | — |
| Hyperuricemia | Metabolism and nutrition disorders | — | — | — |
| COVID-19 infection | Infections and infestations | — | — | — |
| Myalgia | Musculoskeletal and connective tissue disorders | — | — | — |
| Lower extremity pain | Musculoskeletal and connective tissue disorders | — | — | — |
| Peripheral sensory neuropathy | Nervous system disorders | — | — | — |
| Attention deficit hyperactive disorder | Psychiatric disorders | — | — | — |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | — | — | — |
| Dry skin - Hands | Skin and subcutaneous tissue disorders | — | — | — |
| Erythematous rash, flanks | Skin and subcutaneous tissue disorders | — | — | — |
| small white bumps on lips | Skin and subcutaneous tissue disorders | — | — | — |
| Abdominal Pain | Gastrointestinal disorders | — | — | — |
| Alopecia | General disorders | — | — | — |
| Ataxia | General disorders | — | — | — |
| Eosinophilia | Blood and lymphatic system disorders | — | — | — |
| Dysgeusia | Nervous system disorders | — | — | — |
| Fever | General disorders | — | — | — |
| Fracture | Injury, poisoning and procedural complications | — | — | — |
| Diverticulitis | Gastrointestinal disorders | — | — | — |
Most-reported serious reactions: Diarrhea, Hypokalemia, Arthralgia, Altered mental status, Fever, Streptococcus salivarius, Heart Failure, Hypercalcemia.
Data from ClinicalTrials.gov NCT03401853 adverse events section.
This phase II trial studies how well pembrolizumab with rituximab or obinutuzumab work in treating patients with follicular lymphoma or diffuse large B cell lymphoma that has come back (recurrent) or does not respond to treatment (refractory). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Rituximab and obinutuzumab are monoclonal antibodies. They bind to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Giving pembrolizumab with rituximab or obinutuzumab may help kill more cancer cells in patients with follicular lymphoma or diffuse large B cell lymphoma.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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