Last reviewed · How we verify
Ibrutinib in Treating Minimal Residual Disease in Patients With Chronic Lymphocytic Leukemia After Front-Line Therapy
Phase 2 trial testing Ibrutinib in Stage I Chronic Lymphocytic Leukemia in 35 participants. Completed in 15 January 2026.
| Lead sponsor | Mayo Clinic |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 35 |
| Start date | 8 February 2016 |
| Primary completion | 14 December 2023 |
| Estimated completion | 15 January 2026 |
| Sites | 1 location across United States |
Mayo Clinic
18 and older, any sex, with Stage I Chronic Lymphocytic Leukemia or Stage II Chronic Lymphocytic Leukemia. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
This outcome is summarized by the proportion of patients achieving MRD negative status. A confirmed MRD-negative response is defined as an achievement of MRD-negative status in both the blood and the bone marrow on two consecutive evaluations at least 3 months apart.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Ibrutinib) | 0 |
Time frame: Adverse events were followed for 3 years and mortality was followed for 8 years. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Treatment (Ibrutinib) |
|---|---|---|
| Atrial fibrillation | Cardiac disorders | — |
| Lung infection | Infections and infestations | — |
| Infections and infestations - Oth spec | Infections and infestations | — |
| Skin infection | Infections and infestations | — |
| Febrile neutropenia | Blood and lymphatic system disorders | — |
| Gastrointestinal disorders - Oth spec | Gastrointestinal disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Pancreatitis | Gastrointestinal disorders | — |
| Death NOS | General disorders | — |
| Fever | General disorders | — |
| Allergic reaction | Immune system disorders | — |
| Fracture | Injury, poisoning and procedural complications | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — |
| Arthritis | Musculoskeletal and connective tissue disorders | — |
| Myalgia | Musculoskeletal and connective tissue disorders | — |
| Neoplasms benign, mal, uncpec - Oth spec | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — |
| Headache | Nervous system disorders | — |
| Intracranial hemorrhage | Nervous system disorders | — |
| Acute kidney injury | Renal and urinary disorders | — |
| Renal colic | Renal and urinary disorders | — |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | — |
| Hematoma | Vascular disorders | — |
| Hypotension | Vascular disorders | — |
| Reaction | System | Treatment (Ibrutinib) |
|---|---|---|
| Platelet count decreased | Investigations | — |
| Anemia | Blood and lymphatic system disorders | — |
| Neutrophil count decreased | Investigations | — |
| Hypertension | Vascular disorders | — |
| Lymphocyte count increased | Investigations | — |
| White blood cell decreased | Investigations | — |
| Fatigue | General disorders | — |
| Lymphocyte count decreased | Investigations | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — |
| Headache | Nervous system disorders | — |
| Diarrhea | Gastrointestinal disorders | — |
| Skin infection | Infections and infestations | — |
| Wound infection | Infections and infestations | — |
| Myalgia | Musculoskeletal and connective tissue disorders | — |
| Skin and subcut tissue disord - Oth spec | Skin and subcutaneous tissue disorders | — |
| Atrial fibrillation | Cardiac disorders | — |
| Abdominal pain | Gastrointestinal disorders | — |
| Upper respiratory infection | Infections and infestations | — |
| Hip fracture | Injury, poisoning and procedural complications | — |
| Inj, pois and proced complic - Oth spec | Injury, poisoning and procedural complications | — |
| Alanine aminotransferase increased | Investigations | — |
| Aspartate aminotransferase increased | Investigations | — |
| Investigations - Other, specify | Investigations | — |
| Hypomagnesemia | Metabolism and nutrition disorders | — |
| Hyponatremia | Metabolism and nutrition disorders | — |
| Neoplasms benign, mal, uncpec - Oth spec | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — |
| Peripheral sensory neuropathy | Nervous system disorders | — |
| Syncope | Nervous system disorders | — |
| Psychiatric disorders - Other, specify | Psychiatric disorders | — |
| Alopecia | Skin and subcutaneous tissue disorders | — |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | — |
Most-reported serious reactions: Atrial fibrillation, Lung infection, Infections and infestations - Oth spec, Skin infection, Febrile neutropenia, Gastrointestinal disorders - Oth spec, Nausea, Pancreatitis.
Data from ClinicalTrials.gov NCT02649387 adverse events section.
This phase II trial studies the side effects and how well ibrutinib works in treating patients with chronic lymphocytic leukemia who responded to initial treatment used to reduce a cancer (front-line therapy) but have residual disease. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
1 peer-reviewed publication 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/NCT02649387.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing