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Efficacy and Safety of Zanubrutinib in Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Phase 2 trial testing Zanubrutinib in Relapsed or Refractory Chronic Lymphocytic Leukemia in 91 participants. Completed in 10 September 2020.
| Lead sponsor | BeiGene |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 91 |
| Start date | 9 March 2017 |
| Primary completion | 15 June 2018 |
| Estimated completion | 10 September 2020 |
| Sites | 11 locations across China |
BeiGene — full company profile →
18 and older, any sex, with Relapsed or Refractory Chronic Lymphocytic Leukemia or Relapsed or Refractory 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.
ORR is defined as the number of participants who achieve a best response of CR or, CRi, Nodular Partial Response, PR, and PR with Lymphocytosis as assessed by IRC per the modified IWCLL Guidelines in participants with CLL and the Revised Criteria for Response for Malignant Lymphoma in participants with SLL.
| Group | Value | 95% CI |
|---|---|---|
| Zanubrutinib | 80 |
PFS is defined as the time from treatment initiation to first documentation of progression by International workshop on chronic lymphocytic leukemia (IWCLL) criteria/revised criteria for response for malignant lymphoma or death, whichever is earlier.
| Group | Value | 95% CI |
|---|---|---|
| Zanubrutinib | 93.3 | 85.72 – 96.94 |
| Group | Value | 95% CI |
|---|---|---|
| Zanubrutinib | 88.7 | 80.04 – 93.77 |
| Group | Value | 95% CI |
|---|---|---|
| Zanubrutinib | 80.5 | 70.52 – 87.42 |
| Group | Value | 95% CI |
|---|---|---|
| Zanubrutinib | 68.1 | 56.56 – 77.24 |
DOR is defined as the time from the date that response criteria are first met to the date that progressive disease (PD) is objectively documented or death, whichever occurs first
| Group | Value | 95% CI |
|---|---|---|
| Zanubrutinib | 97.5 | 90.37 – 99.37 |
| Group | Value | 95% CI |
|---|---|---|
| Zanubrutinib | 92.5 | 83.96 – 96.54 |
| Group | Value | 95% CI |
|---|---|---|
| Zanubrutinib | 83.4 | 73.20 – 90.04 |
| Group | Value | 95% CI |
|---|---|---|
| Zanubrutinib | 69.9 | 57.02 – 79.55 |
TTR is defined as the time from treatment initiation to first signs of response
| Group | Value | 95% CI |
|---|---|---|
| Zanubrutinib | 2.79 | 2.6 – 16.8 |
Overall response was defined as achieving a best overall response of CR, CRi, nodular partial response (nPR), PR, or partial response with lymphocytosis (PR-L).
| Group | Value | 95% CI |
|---|---|---|
| Zanubrutinib | 92.3 | 84.79 – 96.85 |
An adverse event (AE) was defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All AEs were monitored per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE version \[v\] 4.03 2010). A treatment emergent adverse event (TEAE) is defined as an adverse event that has an onset date or a worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days
| Group | Value | 95% CI |
|---|---|---|
| Zanubrutinib | 91 |
| Group | Value | 95% CI |
|---|---|---|
| Zanubrutinib | 76 |
| Group | Value | 95% CI |
|---|---|---|
| Zanubrutinib | 47 |
| Group | Value | 95% CI |
|---|---|---|
| Zanubrutinib | 6 |
| Group | Value | 95% CI |
|---|---|---|
| Zanubrutinib | 14 |
| Group | Value | 95% CI |
|---|---|---|
| Zanubrutinib | 42 |
| Group | Value | 95% CI |
|---|---|---|
| Zanubrutinib | 42 |
| Group | Value | 95% CI |
|---|---|---|
| Zanubrutinib | 8 |
Time frame: Up to 3.5 years. Reporting threshold: 3%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Zanubrutinib |
|---|---|---|
| Pneumonia | Infections and infestations | — |
| Lung infection | Infections and infestations | — |
| Upper respiratory tract infection | Infections and infestations | — |
| Bronchitis | Infections and infestations | — |
| Hepatitis B | Infections and infestations | — |
| Gastroenteritis | Infections and infestations | — |
| Skin infection | Infections and infestations | — |
| Headache | Nervous system disorders | — |
| Adenocarcinoma gastric | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — |
| Anaemia | Blood and lymphatic system disorders | — |
| Cardiac failure | Cardiac disorders | — |
| Cardiopulmonary failure | Cardiac disorders | — |
| Myocardial ischaemia | Cardiac disorders | — |
| Intestinal obstruction | Gastrointestinal disorders | — |
| Multiple organ dysfunction syndrome | General disorders | — |
| Cholecystitis | Hepatobiliary disorders | — |
| Anorectal infection | Infections and infestations | — |
| Dermatitis infected | Infections and infestations | — |
| Pneumonia fungal | Infections and infestations | — |
| Splenic infection | Infections and infestations | — |
| Hand fracture | Injury, poisoning and procedural complications | — |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — |
| Haemorrhage intracranial | Nervous system disorders | — |
| Post herpetic neuralgia | Nervous system disorders | — |
| Reaction | System | Zanubrutinib |
|---|---|---|
| Neutrophil count decreased | Investigations | — |
| Upper respiratory tract infection | Infections and infestations | — |
| Haematuria | Renal and urinary disorders | — |
| Platelet count decreased | Investigations | — |
| Anaemia | Blood and lymphatic system disorders | — |
| Purpura | Skin and subcutaneous tissue disorders | — |
| Hypokalaemia | Metabolism and nutrition disorders | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — |
| Hyperglycaemia | Metabolism and nutrition disorders | — |
| Pneumonia | Infections and infestations | — |
| Carbon dioxide increased | Investigations | — |
| White blood cell count decreased | Investigations | — |
| Diarrhoea | Gastrointestinal disorders | — |
| Urinary tract infection | Infections and infestations | — |
| Hyperuricaemia | Metabolism and nutrition disorders | — |
| Rash | Skin and subcutaneous tissue disorders | — |
| Alanine aminotransferase increased | Investigations | — |
| Urobilinogen urine increased | Investigations | — |
| Blood bilirubin increased | Investigations | — |
| Proteinuria | Renal and urinary disorders | — |
| Aspartate aminotransferase increased | Investigations | — |
| Hypocalcaemia | Metabolism and nutrition disorders | — |
| Thrombocytopenia | Blood and lymphatic system disorders | — |
| Pyrexia | General disorders | — |
| Blood urine present | Investigations | — |
| Hypoalbuminaemia | Metabolism and nutrition disorders | — |
| Skin infection | Infections and infestations | — |
| Hyponatraemia | Metabolism and nutrition disorders | — |
| Hypertension | Vascular disorders | — |
| Constipation | Gastrointestinal disorders | — |
| Pharyngitis | Infections and infestations | — |
| Abdominal pain upper | Gastrointestinal disorders | — |
| Toothache | Gastrointestinal disorders | — |
| Vomiting | Gastrointestinal disorders | — |
| Bronchitis | Infections and infestations | — |
| Electrocardiogram QT prolonged | Investigations | — |
| Neutrophil percentage decreased | Investigations | — |
| Red blood cells urine positive | Investigations | — |
| Gamma-glutamyltransferase increased | Investigations | — |
| Low density lipoprotein decreased | Investigations | — |
Most-reported serious reactions: Pneumonia, Lung infection, Upper respiratory tract infection, Bronchitis, Hepatitis B, Gastroenteritis, Skin infection, Headache.
Data from ClinicalTrials.gov NCT03206918 adverse events section.
This was a single-arm, open-label, multi-center Phase 2 study in participants with histologically documented CLL/SLL who have relapsed after or refractory to ≥ 1 prior treatment regimen(s). The study is composed of an initial screening phase, a single-arm treatment phase, and a follow-up phase.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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