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A Phase 2 Safety and Efficacy Study of INCB050465 in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (CITADEL-202)
Phase 2 trial testing Parsaclisib in Lymphoma in 60 participants. Completed in 5 February 2021.
| Lead sponsor | Incyte Corporation |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 2 March 2017 |
| Primary completion | 22 February 2019 |
| Estimated completion | 5 February 2021 |
| Sites | 70 locations across France, Italy, Belgium, United Kingdom, Poland, South Korea, Canada, Australia |
Incyte Corporation — full company profile →
18 and older, any sex, with Lymphoma. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Defined as the percentage of subjects with a complete or partial response as defined by Lugano Classification criteria for lymphomas (Cheson et al 2014) as determined by IRC.
| Group | Value | 95% CI |
|---|---|---|
| Group A Parsaclisib (no Prior BTK Inhibitor) | 25.5 | 14.7 – 39.0 |
Defined as the time from first documented evidence of complete or partial response until disease progression or death from any cause among subjects who achieve an objective response as determined by IRC.
| Group | Value | 95% CI |
|---|---|---|
| Group A Parsaclisib (no Prior BTK Inhibitor) | 6.2 | 2.1 – NA |
Defined as the time from the date of the first dose of study drug until the earliest date of disease progression, as determined by radiographic disease assessment as provided by an IRC.
| Group | Value | 95% CI |
|---|---|---|
| Group A Parsaclisib (no Prior BTK Inhibitor) | 2.2 | 2.0 – 4.1 |
Defined as the time from the date of the first dose of study drug until death by any cause.
| Group | Value | 95% CI |
|---|---|---|
| Group A Parsaclisib (no Prior BTK Inhibitor) | 7.0 | 3.5 – NA |
A TEAE is any AE either reported for the first time or worsening of a pre-existing event after the first dose of parsaclisib until 30 days after the last dose administration.
| Group | Value | 95% CI |
|---|---|---|
| Group A Parsaclisib (no Prior BTK Inhibitor) | 50 | |
| Group B Parsaclisib (Prior BTK Inhibitor) | 4 |
Time frame: Screening through 35 days after end of treatment, up to 42 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Group A Parsaclisib (no Pr… | Group B Parsaclisib (Prior… | Total |
|---|---|---|---|---|
| Pyrexia | General disorders | — | — | — |
| Hypercalcaemia | Metabolism and nutrition disorders | — | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — | — |
| General physical health deterioration | General disorders | — | — | — |
| Aspartate aminotransferase increased | Investigations | — | — | — |
| Febrile neutropenia | Blood and lymphatic system disorders | — | — | — |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | — | — | — |
| Urinary tract infection | Infections and infestations | — | — | — |
| Urosepsis | Infections and infestations | — | — | — |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Alanine aminotransferase increased | Investigations | — | — | — |
| Asthenia | General disorders | — | — | — |
| Atrial fibrillation | Cardiac disorders | — | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — | — |
| Cerebrovascular accident | Nervous system disorders | — | — | — |
| Chest pain | General disorders | — | — | — |
| Colitis | Gastrointestinal disorders | — | — | — |
| Confusional state | Psychiatric disorders | — | — | — |
| Deep vein thrombosis | Vascular disorders | — | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — | — |
| Dizziness | Nervous system disorders | — | — | — |
| Enterocolitis | Gastrointestinal disorders | — | — | — |
| Fall | Injury, poisoning and procedural complications | — | — | — |
| Fatigue | General disorders | — | — | — |
| Femoral neck fracture | Injury, poisoning and procedural complications | — | — | — |
| Reaction | System | Group A Parsaclisib (no Pr… | Group B Parsaclisib (Prior… | Total |
|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | — | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Constipation | Gastrointestinal disorders | — | — | — |
| Decreased appetite | Metabolism and nutrition disorders | — | — | — |
| Fatigue | General disorders | — | — | — |
| Neutrophil count decreased | Investigations | — | — | — |
| Pyrexia | General disorders | — | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — | — |
| Fall | Injury, poisoning and procedural complications | — | — | — |
| Hyponatraemia | Metabolism and nutrition disorders | — | — | — |
| Oedema peripheral | General disorders | — | — | — |
| Pruritus | Skin and subcutaneous tissue disorders | — | — | — |
| Urinary tract infection | Infections and infestations | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — |
| Weight decreased | Investigations | — | — | — |
| Anxiety | Psychiatric disorders | — | — | — |
| Chills | General disorders | — | — | — |
| Dry mouth | Gastrointestinal disorders | — | — | — |
| Headache | Nervous system disorders | — | — | — |
| Hyperglycaemia | Metabolism and nutrition disorders | — | — | — |
| Hypokalaemia | Metabolism and nutrition disorders | — | — | — |
| Hypomagnesaemia | Metabolism and nutrition disorders | — | — | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — | — | — |
| Rash | Skin and subcutaneous tissue disorders | — | — | — |
| Rash erythematous | Skin and subcutaneous tissue disorders | — | — | — |
| Erythema | Skin and subcutaneous tissue disorders | — | — | — |
| General physical health deterioration | General disorders | — | — | — |
| Muscle spasms | Musculoskeletal and connective tissue disorders | — | — | — |
| Nasopharyngitis | Infections and infestations | — | — | — |
| Non-cardiac chest pain | General disorders | — | — | — |
| Rib fracture | Injury, poisoning and procedural complications | — | — | — |
| Urticaria | Skin and subcutaneous tissue disorders | — | — | — |
| Asthma | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Balance disorder | Nervous system disorders | — | — | — |
| Bronchopulmonary aspergillosis | Infections and infestations | — | — | — |
Most-reported serious reactions: Pyrexia, Hypercalcaemia, Abdominal pain, General physical health deterioration, Aspartate aminotransferase increased, Febrile neutropenia, Rash maculo-papular, Urinary tract infection.
Data from ClinicalTrials.gov NCT02998476 adverse events section.
The purpose of this study is to assess the safety and efficacy of parsaclisib in subjects with relapsed or refractory diffuse large B-cell lymphoma.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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