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A Phase II Study Using Ibrutinib and Short-Course Fludarabine in Treatment-Naive CLL
Phase 2 trial testing Ibrutinib in Chronic Lymphocytic Leukemia in 29 participants. Participants enrolled and being followed up; not accepting new ones.
| Lead sponsor | National Heart, Lung, and Blood Institute (NHLBI) |
|---|---|
| Phase | Phase 2 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 29 |
| Start date | 9 December 2015 |
| Primary completion | 2 October 2019 |
| Estimated completion | 23 October 2034 |
| Sites | 1 location across United States |
National Heart, Lung, and Blood Institute (NHLBI)
18 and older, any sex, with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Rate of complete response at 24 weeks or after 6 cycles. Response assessment was conducted according to the guidelines from the 2008 International Workshop on Chronic Lymphocytic Leukemia (IWCLL).
| Group | Value | 95% CI |
|---|---|---|
| Ibrutinib With Fludarabine in Patients With CLL or SLL | 6 | |
| Ibrutinib With Fludarabine in Patients With CLL or SLL | 21 | |
| Ibrutinib With Fludarabine in Patients With CLL or SLL | 1 |
Rate of treatment discontinuation within the first 24 weeks or 6 cycles due to intolerable side effects from study therapy
| Group | Value | 95% CI |
|---|---|---|
| Ibrutinib With Fludarabine in Patients With CLL or SLL | 1 | |
| Ibrutinib With Fludarabine in Patients With CLL or SLL | 28 |
Time frame: From treatment initiation until the last follow-up on study or death, whichever occurred first, assessed up to 4 years. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Ibrutinib With Fludarabine… |
|---|---|---|
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — |
| Alanine aminotransferase increased | Investigations | — |
| Aspartate aminotransferase increased | Investigations | — |
| Lung infection | Infections and infestations | — |
| Appendicitis | Infections and infestations | — |
| Cholecystitis | Hepatobiliary disorders | — |
| Death NOS | General disorders and administration site conditions | — |
| Vomiting | Gastrointestinal disorders | — |
| Heart Failure | Cardiac disorders | — |
| Hyponatremia | Metabolism and nutrition disorders | — |
| Non-cardiac chest pain | General disorders and administration site conditions | — |
| Palpitations | Cardiac disorders | — |
| Pancreatitis | Gastrointestinal disorders | — |
| Post-operative Hemorrhage (Epistaxis) | Injury, poisoning and procedural complications | — |
| Sepsis | Infections and infestations | — |
| Thromboembolic event | Vascular disorders | — |
| Urinary tract infection | Infections and infestations | — |
| Ventricular arrhythmia | Cardiac disorders | — |
| Vulvar intraepithelial neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — |
| Prostate Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — |
| Triple negative Breast Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — |
| Papillary Thyroid Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — |
| Reaction | System | Ibrutinib With Fludarabine… |
|---|---|---|
| White blood cell decreased | Investigations | — |
| Bruising | Injury, poisoning and procedural complications | — |
| Leukocytosis | Blood and lymphatic system disorders | — |
| Platelet count decresaed | Investigations | — |
| Lymphocyte count decreased | Investigations | — |
| Diarrhea | Gastrointestinal disorders | — |
| Neutrophil count decresaed | Investigations | — |
| Myalgia | Musculoskeletal and connective tissue disorders | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — |
| Fatigue | General disorders | — |
| Hypertension | Vascular disorders | — |
| Brittle nails | Skin and subcutaneous tissue disorders | — |
| Lymphocyte count increased | Investigations | — |
| Pain | General disorders and administration site conditions | — |
| Peripheral edema | General disorders | — |
| Petechiae | Skin and subcutaneous tissue disorders | — |
| Shingles | Infections and infestations | — |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | — |
| Maculopapular rash | Skin and subcutaneous tissue disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Headache | Nervous system disorders | — |
| Alanine or aspartate aminotransferase increased | Investigations | — |
| Anemia | Blood and lymphatic system disorders | — |
| Creatinine increased | Investigations | — |
| Hyperuricemia | Metabolism and nutrition disorders | — |
| Hypocalcemia | Metabolism and nutrition disorders | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — |
| Dizziness | Nervous system disorders | — |
| Vomiting | Gastrointestinal disorders | — |
| Lung infection | Infections and infestations | — |
| Hyponatremia | Metabolism and nutrition disorders | — |
| Flu like symptoms | General disorders | — |
| Gastroesophageal reflux disease | Gastrointestinal disorders | — |
| Hematoma | Blood and lymphatic system disorders | — |
| Hematuria | Renal and urinary disorders | — |
| Hypophosphatemia | Metabolism and nutrition disorders | — |
| Infections and infestations: other | Infections and infestations | — |
| Productive cough | Infections and infestations | — |
| Sinusitis | Infections and infestations | — |
| Urinary tract infection | Renal and urinary disorders | — |
Most-reported serious reactions: Squamous cell carcinoma, Alanine aminotransferase increased, Aspartate aminotransferase increased, Lung infection, Appendicitis, Cholecystitis, Death NOS, Vomiting.
Data from ClinicalTrials.gov NCT02514083 adverse events section.
This is a pilot phase 2 study investigating the safety and efficacy of ibrutinib combined with short-course fludarabine in previously untreated CLL patients. Ibrutinib will be given daily until disease progression or intolerable side effects occur. Fludarabine will be given in cycles 3 and 4. The primary efficacy endpoint is the rate of complete response after 6 cycles or 24 weeks. The primary safety endpoint is the rate of treatment discontinuation after 6 cycles or 24 weeks.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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