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Entospletinib Plus Intensive Induction/Consolidation Chemotherapy in Newly Diagnosed NPM1-mutated AML
Phase 3 trial testing Entospletinib in Nucleophosmin 1-mutated Acute Myeloid Leukemia in 15 participants. Terminated before completion.
| Lead sponsor | Kronos Bio |
|---|---|
| Phase | Phase 3 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 15 |
| Start date | 24 November 2021 |
| Primary completion | 30 March 2023 |
| Estimated completion | 30 March 2023 |
| Sites | 83 locations across France, Italy, Germany, Hungary, Israel, Poland, South Korea, Canada |
Kronos Bio — full company profile →
Adults 18 to 74, any sex, with Nucleophosmin 1-mutated Acute Myeloid Leukemia. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
CR as defined by ELN 2017 criteria (with minor modification for neutrophil and platelet count thresholds as defined by IWG) as assessed by study site investigators.
| Group | Value | 95% CI |
|---|---|---|
| ENTO | 5 | |
| Placebo | 5 |
A TEAE is any untoward medical occurrence in a clinical study participant, beginning or worsening from Cycle 1, Day 1 through 30 days following study treatment completion, temporarily associated with the use of treatment, whether or not considered related to the study treatment. TEAEs were recorded according to the most current version of the Medical Dictionary for Regulatory Activities (MedDRA). Clinically significant changes in safety laboratory assessments, electrocardiograms, echocardiogram / multi-gated acquisition scans and Eastern Cooperative Oncology Group performance status findings,
| Group | Value | 95% CI |
|---|---|---|
| ENTO | 8 | |
| Placebo | 7 |
Time frame: Serious adverse events and deaths were collected from signing informed consent through 30 days after treatment completion, up to 212 days. Other adverse events were collected from Day 1 of Cycle 1 through 30 days after treatment completion, up to 198 days.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | ENTO | Placebo |
|---|---|---|---|
| Klebsiella bacteraemia | Infections and infestations | — | — |
| Sepsis | Infections and infestations | — | — |
| Febrile neutropenia | Blood and lymphatic system disorders | — | — |
| Colitis | Gastrointestinal disorders | — | — |
| Anorectal infection | Infections and infestations | — | — |
| Clostridium colitis | Infections and infestations | — | — |
| Enterobacter sepsis | Infections and infestations | — | — |
| Fungal sepsis | Infections and infestations | — | — |
| Pneumonia fungal | Infections and infestations | — | — |
| Pneumonia legionella | Infections and infestations | — | — |
| Septic shock | Infections and infestations | — | — |
| Staphylococcal bacteraemia | Infections and infestations | — | — |
| Urinary tract infection | Infections and infestations | — | — |
| Vulvitis | Infections and infestations | — | — |
| Atrial fibrillation | Cardiac disorders | — | — |
| Mucosal inflammation | General disorders | — | — |
| Hypertransaminasaemia | Hepatobiliary disorders | — | — |
| Reaction | System | ENTO | Placebo |
|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Thrombocytopenia | Blood and lymphatic system disorders | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — |
| Constipation | Gastrointestinal disorders | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — |
| Neutropenia | Blood and lymphatic system disorders | — | — |
| Leukopenia | Blood and lymphatic system disorders | — | — |
| Fatigue | General disorders | — | — |
| Hypokalaemia | Metabolism and nutrition disorders | — | — |
| Decreased appetite | Metabolism and nutrition disorders | — | — |
| Alanine aminotransferase increased | Investigations | — | — |
| Pyrexia | General disorders | — | — |
| Chills | General disorders | — | — |
| Cellulitis | Infections and infestations | — | — |
| COVID-19 | Infections and infestations | — | — |
| Gastrointestinal infection | Infections and infestations | — | — |
| Hypervolaemia | Metabolism and nutrition disorders | — | — |
| Aspartate aminotransferase increased | Investigations | — | — |
| Blood bilirubin increased | Investigations | — | — |
| Rash | Skin and subcutaneous tissue disorders | — | — |
| Headache | Nervous system disorders | — | — |
| Insomnia | Psychiatric disorders | — | — |
| Hypertension | Vascular disorders | — | — |
| Hypotension | Vascular disorders | — | — |
| Renal cyst | Renal and urinary disorders | — | — |
| Colitis | Gastrointestinal disorders | — | — |
| Stomatitis | Gastrointestinal disorders | — | — |
| Abdominal discomfort | Gastrointestinal disorders | — | — |
| Abdominal distension | Gastrointestinal disorders | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — |
| Abdominal pain upper | Gastrointestinal disorders | — | — |
| Cheilitis | Gastrointestinal disorders | — | — |
| Flatulence | Gastrointestinal disorders | — | — |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | — | — |
| Haemorrhoids | Gastrointestinal disorders | — | — |
| Large intestinal stenosis | Gastrointestinal disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | — | — |
| Mucosal inflammation | General disorders | — | — |
Most-reported serious reactions: Klebsiella bacteraemia, Sepsis, Febrile neutropenia, Colitis, Anorectal infection, Clostridium colitis, Enterobacter sepsis, Fungal sepsis.
Data from ClinicalTrials.gov NCT05020665 adverse events section.
The primary objective of this study is to evaluate the efficacy of entospletinib (ENTO) compared to placebo when added to chemotherapy in previously untreated nucleophosmin-1 mutated (NPM1-m) acute myeloid leukemia (AML), as defined by the rate of molecularly defined measurable residual disease (MRD).
8 peer-reviewed publications reference this trial (live from Europe PMC):
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