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(Strategic/Business Decision)
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The main objective of this study is to determine the progression free survival of umbralisib in participants who were intolerant to prior BTK (Bruton Tyrosine Kinase) inhibitors (ibrutinib, ACP-196, other) or prior PI3K-delta inhibitors (idelalisib, duvelisib, other).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Umbralisib | Experimental | Participants received 800 milligrams (mg) of umbralisib, orally, once daily until disease progression, unacceptable toxicity or the end of the study for 60.7 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Umbralisib | Drug | Umbralisib was administered as a tablet(s), orally once daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival | PFS was defined as the interval from Day 1 to the earlier of the first documentation of definitive disease progression (PD) or death from any cause. Participants who had no event (progression or death) were censored at the day of their last adequate disease assessment. | From Day 1 to the earlier of the first documentation of definitive disease progression or death (Up to 61.7 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | ORR=percent of participants who achieve complete response (CR), or partial response (PR). | Up to 61.7 months |
| Time to Treatment Failure (TTF) | TTF is defined as a composite endpoint measuring time from Day 1 to discontinuation of treatment for any reason, including disease progression, treatment toxicity, and death. Estimates of median TTF was made using Kaplan-Meier methods. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anthony Mato, MD | University of Pennsylvania Center for CLL | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TG Therapeutics Investigational Trial Site | Huntsville | Alabama | 35805 | United States | ||
| TG Therapeutics Investigational Trial Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27601462 | Derived | Mato AR, Nabhan C, Barr PM, Ujjani CS, Hill BT, Lamanna N, Skarbnik AP, Howlett C, Pu JJ, Sehgal AR, Strelec LE, Vandegrift A, Fitzpatrick DM, Zent CS, Feldman T, Goy A, Claxton DF, Bachow SH, Kaur G, Svoboda J, Nasta SD, Porter D, Landsburg DJ, Schuster SJ, Cheson BD, Kiselev P, Evens AM. Outcomes of CLL patients treated with sequential kinase inhibitor therapy: a real world experience. Blood. 2016 Nov 3;128(18):2199-2205. doi: 10.1182/blood-2016-05-716977. Epub 2016 Sep 6. |
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Data will be available upon study closure or as the study evolves
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A total of 51 participants took part in the study at 15 investigative sites in the United States, from 21 April 2016 to 10 June 2021.
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| ID | Title | Description |
|---|---|---|
| FG000 | Umbralisib | Participants received 800 milligrams (mg) of umbralisib, orally, once daily until disease progression, unacceptable toxicity or the end of the study for 60.7 months. Umbralisib: Umbralisib was administered as a tablet(s), orally once daily. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 4, 2019 |
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| From Day 1 to discontinuation of treatment for any reason, including disease progression, treatment toxicity, and death (up to approximately 61.7 months) |
| Duration of Response (DOR) | DOR defined as the interval from the first documentation of CR or PR to the earlier of the first documentation of definitive disease progression or death from any cause. Estimates of median DOR was made using Kaplan-Meier methods. | From first documentation of CR or PR till disease progression/death (up to approximately 61.7 months) |
| Number of Participants With Treatment-Emergent Adverse Events (TEAE's) as Assessed by Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0) | An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product. An AE does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAE is any AE that occur after first dosing of study medication and through the end of the study or through 30 days after the last dose of study treatment, or is considered treatment-related regardless of the start date of the event, or is present before first dosing of study medication but worsens in intensity or the investigator subsequently considers treatment-related. TEAEs included both serious and non-serious TEAEs. | From first dose of study treatment up to end of study (up to 61.7 months) |
| Washington D.C. |
| District of Columbia |
| 20007 |
| United States |
| TG Therapeutics Investigational Trial Site | Fort Myers | Florida | 33916 | United States |
| TG Therapeutics Investigational Trial Site | St. Petersburg | Florida | 33705 | United States |
| TG Therapeutics Investigational Trial Site | Kansas City | Missouri | 64132 | United States |
| TG Therapeutics Investigational Trial Site | Lebanon | New Hampshire | 03756 | United States |
| TG Therapeutics Investigational Trial Site | Hackensack | New Jersey | 07601 | United States |
| TG Therapeutics Investigational Trial Site | New Hyde Park | New York | 11042 | United States |
| TG Therapeutics Investigational Trial Site | New York | New York | 10032 | United States |
| TG Therapeutics Investigational Trial Site | Rochester | New York | 14642 | United States |
| TG Therapeutics Investigational Trial Site | Durham | North Carolina | 27710 | United States |
| TG Therapeutics Investigational Trial Site | Hershey | Pennsylvania | 17033 | United States |
| TG Therapeutics Investigational Trial Site | Philadelphia | Pennsylvania | 19146 | United States |
| TG Therapeutics Investigational Trial Site | Nashville | Tennessee | 37203 | United States |
| TG Therapeutics Investigational Trial Site | Seattle | Washington | 98104 | United States |
| COMPLETED |
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| NOT COMPLETED |
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The safety population included all participants who received at least one dose of study treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Umbralisib | Participants received 800 mg of umbralisib, orally, once daily until disease progression, unacceptable toxicity or the end of the study for 60.7 months. Umbralisib: Umbralisib was administered as a tablet(s), orally once daily. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression-free Survival | PFS was defined as the interval from Day 1 to the earlier of the first documentation of definitive disease progression (PD) or death from any cause. Participants who had no event (progression or death) were censored at the day of their last adequate disease assessment. | The modified Intent to Treat (mITT) population included all participants who were treated with study drug and provided at least one efficacy assessment. | Posted | Median | 95% Confidence Interval | months | From Day 1 to the earlier of the first documentation of definitive disease progression or death (Up to 61.7 months) |
|
|
| |||||||||||||||||||||||||
| Secondary | Overall Response Rate (ORR) | ORR=percent of participants who achieve complete response (CR), or partial response (PR). | The mITT population included all participants who were treated with study drug and provided at least one efficacy assessment. | Posted | Number | percentage of participants | Up to 61.7 months |
|
| |||||||||||||||||||||||||||
| Secondary | Time to Treatment Failure (TTF) | TTF is defined as a composite endpoint measuring time from Day 1 to discontinuation of treatment for any reason, including disease progression, treatment toxicity, and death. Estimates of median TTF was made using Kaplan-Meier methods. | The mITT population included all participants who were treated with study drug and provided at least one efficacy assessment. | Posted | Median | 95% Confidence Interval | months | From Day 1 to discontinuation of treatment for any reason, including disease progression, treatment toxicity, and death (up to approximately 61.7 months) |
|
| ||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) | DOR defined as the interval from the first documentation of CR or PR to the earlier of the first documentation of definitive disease progression or death from any cause. Estimates of median DOR was made using Kaplan-Meier methods. | The mITT population included all participants who were treated with study drug and provided at least one efficacy assessment. Here, Overall number of participants analyzed signifies those who have documented CR or PR. | Posted | Median | 95% Confidence Interval | months | From first documentation of CR or PR till disease progression/death (up to approximately 61.7 months) |
|
| ||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAE's) as Assessed by Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0) | An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product. An AE does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAE is any AE that occur after first dosing of study medication and through the end of the study or through 30 days after the last dose of study treatment, or is considered treatment-related regardless of the start date of the event, or is present before first dosing of study medication but worsens in intensity or the investigator subsequently considers treatment-related. TEAEs included both serious and non-serious TEAEs. | The safety population included all participants who received at least one dose of study treatment. | Posted | Count of Participants | Participants | From first dose of study treatment up to end of study (up to 61.7 months) |
|
From first dose of study treatment up to end of study (up to approximately 61.7 months)
The safety population included all participants who received at least one dose of study treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Umbralisib | Participants received 800 mg of umbralisib, orally, once daily until disease progression, unacceptable toxicity or the end of the study for 60.7 months. Umbralisib: Umbralisib was administered as a tablet(s), orally once daily. | 3 | 51 | 22 | 51 | 51 | 51 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
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| Colitis | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Pancreatitis | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Pancreatitis acute | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Hypersensitivity | Immune system disorders | MedDRA 23.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Intervertebral discitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Urinary tract infection bacterial | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
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| Influenza A virus test positive | Investigations | MedDRA 23.0 | Systematic Assessment |
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| Platelet count decreased | Investigations | MedDRA 23.0 | Systematic Assessment |
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| Transaminases increased | Investigations | MedDRA 23.0 | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
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| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
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| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
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| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
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| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
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| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
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| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Urticaria | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Deep vein thrombosis | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
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| Embolism | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
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| Leukocytosis | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA 23.0 | Systematic Assessment |
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| Neutrophil count decreased | Investigations | MedDRA 23.0 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA 23.0 | Systematic Assessment |
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| Blood alkaline phosphatase increased | Investigations | MedDRA 23.0 | Systematic Assessment |
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| Platelet count decreased | Investigations | MedDRA 23.0 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Tremor | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
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Due to sponsor's business decision, the clinical trial was terminated by the sponsor prematurely.
PI is restricted from publication until after the multi-center paper is published.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| TG Therapeutics Clinical Support Team | TG Therapeutics | 1-877-575-8489 | clinicalsupport@tgtxinc.com |
| Jun 7, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000626319 | umbralisib |
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| Units | Counts |
|---|---|
| Participants |
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