Efficacy and Safety of Tenalisib (RP6530) in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04204057|
Recruitment Status : Completed
First Posted : December 18, 2019
Results First Posted : July 22, 2021
Last Update Posted : July 23, 2021
|Condition or disease||Intervention/treatment||Phase|
|Leukemia, Lymphocytic, Chronic, B-Cell||Drug: Tenalisib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||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.|
|Masking:||None (Open Label)|
|Masking Description:||None (open label)|
|Official Title:||A Phase 2, Open Label Study to Assess the Efficacy and Safety of Tenalisib (RP6530), a Novel PI3K Dual δ/γ Inhibitor, in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL)|
|Actual Study Start Date :||November 28, 2019|
|Actual Primary Completion Date :||October 2, 2020|
|Actual Study Completion Date :||October 2, 2020|
Patients receive Tenalisib 800 mg BID, Orally in 28-Day cycle for 7 cycles
Tenalisib 800 mg BID, Orally
Other Name: RP6530
- Overall Response Rate (ORR) [ Time Frame: 7 Months ]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."
- Duration of Response (DoR) [ Time Frame: 7 Months ]
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.
- Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE Criteria v5.0 [ Time Frame: 7 Months ]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.
- Progression Free Survival (PFS) [ Time Frame: 7 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04204057
|University Multiprofile Hospital for Active Treatment "Dr Georgi Stranski" Ltd.,|
|Pleven, Bulgaria, 5800|
|University Multiprofile Hospital for Active Treatment "Sv Ivan Rilski" Ltd|
|Sofia, Bulgaria, 1431|
|Ltd. M.Zodelava Hematology Centre|
|Medivest - Institute of Hematology and Transfusiology|
|Silesian Healthy Blood Clinic Grosicki, Grosicka Sp.J.|
|Chorzow, Poland, 41-503|
|Voivodship Multi-Specialist Center for Oncology and Traumatology M. Copernicus|