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Nivolumab in Treating Patients With Primary Myelofibrosis, Post-Essential Thrombocythemia Myelofibrosis, or Post-Polycythemia Vera Myelofibrosis
Phase 2 trial testing Laboratory Biomarker Analysis in Hepatomegaly in 8 participants. Terminated before completion.
| Lead sponsor | M.D. Anderson Cancer Center |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 8 |
| Start date | 14 May 2015 |
| Primary completion | 13 April 2018 |
| Estimated completion | 13 April 2018 |
| Sites | 1 location across United States |
M.D. Anderson Cancer Center — full company profile →
18 and older, any sex, with Hepatomegaly or Myelofibrosis Transformation in Essential Thrombocythemia. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Responses will be categorized according to the revised International Working Group-Myeloproliferative Neoplasms Research and Treatment and European LeukmiaNet consensus criteria for myelofibrosis.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Nivolumab) | 0 |
Time frame: 2 years, 5 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Treatment (Nivolumab) |
|---|---|---|
| Anemia | Blood and lymphatic system disorders | — |
| Gastric Hemorrhage | Gastrointestinal disorders | — |
| Abdominal Pain | General disorders | — |
| Acute Kidney Injury | Renal and urinary disorders | — |
| Back Pain | General disorders | — |
| Chest Pain | General disorders | — |
| Chronic Kidney Disease | Renal and urinary disorders | — |
| Esophageal Varices Hemorrhage | Gastrointestinal disorders | — |
| Facial Nerve Disorder | Nervous system disorders | — |
| Fall | Injury, poisoning and procedural complications | — |
| Fever | General disorders | — |
| Headache | General disorders | — |
| Infection | Infections and infestations | — |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | — |
| Urinary Tract Infection | Infections and infestations | — |
| Urticaria | Skin and subcutaneous tissue disorders | — |
| Reaction | System | Treatment (Nivolumab) |
|---|---|---|
| Constipation | Gastrointestinal disorders | — |
| Pain | General disorders | — |
| Infection | Infections and infestations | — |
| Hyperbilirubinemia | Investigations | — |
| Edema | General disorders | — |
| Hypertension | Vascular disorders | — |
| Diarrhea | Gastrointestinal disorders | — |
| Myalgia | Musculoskeletal and connective tissue disorders | — |
| Hemorrhage | Nervous system disorders | — |
| Neutropenic Fever | Infections and infestations | — |
| Leptomeningeal disease | Blood and lymphatic system disorders | — |
| Fever | General disorders | — |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | — |
| Acute Kidney Injury | Renal and urinary disorders | — |
| Peripheral Neuropathy | Nervous system disorders | — |
| Increased Transaminases | Investigations | — |
| Mucositis | Gastrointestinal disorders | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — |
| Anemia | Blood and lymphatic system disorders | — |
| Neutropenia | Blood and lymphatic system disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Cardiomegaly | Cardiac disorders | — |
| Hyperglycemia | Metabolism and nutrition disorders | — |
| Abdominal distention | Gastrointestinal disorders | — |
| Allergic Rhinitis | Respiratory, thoracic and mediastinal disorders | — |
| Bruising | General disorders | — |
| Chills | General disorders | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — |
| Dermatitis | Skin and subcutaneous tissue disorders | — |
| Dizziness | Nervous system disorders | — |
| Elevated Alkaline Phophatase | Investigations | — |
| Elevated Creatinine | Investigations | — |
| Esophageal Varicies | Gastrointestinal disorders | — |
| Hemoptysis | Respiratory, thoracic and mediastinal disorders | — |
| Hemotympanum | Ear and labyrinth disorders | — |
| Hepatobiliary disorder | Hepatobiliary disorders | — |
| Hypoalbuminemia | Metabolism and nutrition disorders | — |
| Hypokalemia | Metabolism and nutrition disorders | — |
| Insomnia | Psychiatric disorders | — |
| Joint Swelling | Musculoskeletal and connective tissue disorders | — |
Most-reported serious reactions: Anemia, Gastric Hemorrhage, Abdominal Pain, Acute Kidney Injury, Back Pain, Chest Pain, Chronic Kidney Disease, Esophageal Varices Hemorrhage.
Data from ClinicalTrials.gov NCT02421354 adverse events section.
This phase II trial studies how well nivolumab works in treating patients with primary myelofibrosis, post-essential thrombocythemia myelofibrosis, or post-polycythemia vera myelofibrosis. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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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/NCT02421354.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing