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The trial is a Phase II, open label, Simon's two stage study design to evaluate the efficacy and safety of Tenalisib in patients with CLL who have relapsed or are refractory after at least one prior therapy.
Tenalisib is a highly specific and orally available dual PI3K δ/γ inhibitor. Pre-clinical experiments demonstrated that Tenalisib is highly effective in killing primary CLL cells in vitro. A Phase II study is planned to evaluate the efficacy and safety of Tenalisib in patients with relapsed/refractory CLL.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tenalisib | Experimental | Patients receive Tenalisib 800 mg BID, Orally in 28-Day cycle for 7 cycles |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tenalisib | Drug | Tenalisib 800 mg BID, Orally |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | Per Response Evaluation Criteria as defined by iwCLL guideline for CLL: Complete Response (CR), all parameters should be regressed to normal (lymph nodes ≥ 1.5 cm; spleen size <13 cm; liver size normal; no constitutional symptoms; circulating lymphocyte count normal; platelet count ≥ 100 x 109 /L; Hemoglobin ≥ 11.0 g/dL). For partial response, at least two of the parameters (lymph nodes, liver and/or spleen size, constitutional symptoms, circulating lymphocyte count) and one parameter (platelet count, hemoglobin) need to improve if previously abnormal; Overall Response (OR) = CR + PR." | 7 Months |
| Duration of Response (DoR) | Duration of response (DOR): DOR is defined as the interval from the first documentation of CR/PR to the first documentation of definitive disease progression or death from any cause. Progression disease is defined using iwCLL criteria as at least one of the criteria of parameters (i.e., lymph nodes increase ≥ 50% from baseline or from response; liver and/or spleen size increase ≥ 50% from baseline or from response; any constitutional symptoms; circulating lymphocyte count increase ≥ 50% over baseline) or criteria of parameters (i.e., platelet count decrease of ≥ 50% over baseline secondary to CLL; hemoglobin decrease of ≥ 50% over baseline secondary to CLL) should be met. | 7 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE Criteria v5.0 | Summary of Treatment-Emergent Adverse Events-(Causality All). Patients will be monitored for adverse events and both related and as well as non-related adverse events will be captured during the study. All adverse events (irrespective of causality) will be reported. | 7 Months |
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Inclusion Criteria:
Exclusion Criteria:
Richter's (large cell) transformation, or PLL transformation.
Cancer therapy/ any cancer investigational drug within 3 weeks (21 days) or 5 half-lives (whichever is shorter).
Prior exposure to drug that inhibits PI3K
Patient with ASCT/Allo-SCT receiving treatment for active GVHD.
Ongoing severe systemic bacterial, fungal or viral infection.
Central nervous system (CNS) involvement of leukemia or lymphoma.
Ongoing immunosuppressive therapy including systemic corticosteroids.
Known history of severe liver injury as judge by investigator.
Any severe and/or uncontrolled medical conditions or other conditions that could affect patient participation
Women who are pregnant or lactating.
Known seropositive requiring anti-viral therapy for i. human immunodeficiency virus (HIV) infection. ii. hepatitis B virus (HBV) infection iii. hepatitis c virus (HCV) infection iv. active CMV infection
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Multiprofile Hospital for Active Treatment "Dr Georgi Stranski" Ltd., | Pleven | 5800 | Bulgaria | |||
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| ID | Title | Description |
|---|---|---|
| FG000 | Tenalisib | Patients receive Tenalisib 800 mg BID, Orally in 28-Day cycle for 7 cycles Tenalisib: Tenalisib 800 mg BID, Orally |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tenalisib | Patients receive Tenalisib 800 mg BID, Orally in 28-Day cycle for 7 cycles Tenalisib: Tenalisib 800 mg BID, Orally |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Overall Response Rate (ORR) | Per Response Evaluation Criteria as defined by iwCLL guideline for CLL: Complete Response (CR), all parameters should be regressed to normal (lymph nodes ≥ 1.5 cm; spleen size <13 cm; liver size normal; no constitutional symptoms; circulating lymphocyte count normal; platelet count ≥ 100 x 109 /L; Hemoglobin ≥ 11.0 g/dL). For partial response, at least two of the parameters (lymph nodes, liver and/or spleen size, constitutional symptoms, circulating lymphocyte count) and one parameter (platelet count, hemoglobin) need to improve if previously abnormal; Overall Response (OR) = CR + PR." | Patients who received at least 1 dose of study medication and provided at least 1 post-baseline efficacy assessment | Posted | Number | 95% Confidence Interval | percentage of participants | 7 Months |
|
7 months
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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 | Tenalisib | Patients receive Tenalisib 800 mg BID, Orally in 28-Day cycle for 7 cycles Tenalisib: Tenalisib 800 mg BID, Orally |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prajak Barde MD | Rhizen Pharmaceuticals | +41325800175 | pjb@rhizen.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 12, 2019 | Jul 2, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 14, 2020 | Jul 2, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C000706530 | tenalisib |
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The trial is a Phase II, open label, Simon's two stage study design to evaluate the efficacy and safety of Tenalisib in patients with CLL who have relapsed or are refractory after at least one prior therapy.
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None (open label)
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| Progression Free Survival (PFS) | Progression-free survival (PFS): PFS is defined as the interval from first dose to first documentation of definitive disease progression or death from any cause. | 7 months |
| University Multiprofile Hospital for Active Treatment "Sv Ivan Rilski" Ltd |
| Sofia |
| 1431 |
| Bulgaria |
| Ltd. M.Zodelava Hematology Centre | Tbilisi | Georgia |
| Medivest - Institute of Hematology and Transfusiology | Tbilisi | Georgia |
| Silesian Healthy Blood Clinic Grosicki, Grosicka Sp.J. | Chorzów | 41-503 | Poland |
| Voivodship Multi-Specialist Center for Oncology and Traumatology M. Copernicus | Lodz | Poland |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Duration of Response (DoR) | Duration of response (DOR): DOR is defined as the interval from the first documentation of CR/PR to the first documentation of definitive disease progression or death from any cause. Progression disease is defined using iwCLL criteria as at least one of the criteria of parameters (i.e., lymph nodes increase ≥ 50% from baseline or from response; liver and/or spleen size increase ≥ 50% from baseline or from response; any constitutional symptoms; circulating lymphocyte count increase ≥ 50% over baseline) or criteria of parameters (i.e., platelet count decrease of ≥ 50% over baseline secondary to CLL; hemoglobin decrease of ≥ 50% over baseline secondary to CLL) should be met. | Patients who received at least 1 dose of study medication and provide at least post-baseline efficacy assessment | Posted | Median | 95% Confidence Interval | days | 7 Months |
|
|
|
| Secondary | Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE Criteria v5.0 | Summary of Treatment-Emergent Adverse Events-(Causality All). Patients will be monitored for adverse events and both related and as well as non-related adverse events will be captured during the study. All adverse events (irrespective of causality) will be reported. | Patients who received at least 1 dose of study medication | Posted | Number | participants | 7 Months |
|
|
|
| Secondary | Progression Free Survival (PFS) | Progression-free survival (PFS): PFS is defined as the interval from first dose to first documentation of definitive disease progression or death from any cause. | Patients who received at least 1 dose of study medication and provide at least 1 post-baseline efficacy assessment | Posted | Median | Inter-Quartile Range | days | 7 months |
|
|
|
| 2 |
| 21 |
| 3 |
| 21 |
| 15 |
| 21 |
| Pneumonia | Infections and infestations | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | Systematic Assessment |
|
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| 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 |