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Efficacy and Safety of Tenalisib (RP6530) in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL)

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ClinicalTrials.gov Identifier: NCT04204057
Recruitment Status : Completed
First Posted : December 18, 2019
Results First Posted : July 22, 2021
Last Update Posted : July 23, 2021
Sponsor:
Information provided by (Responsible Party):
Rhizen Pharmaceuticals SA

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Leukemia, Lymphocytic, Chronic, B-Cell
Intervention Drug: Tenalisib
Enrollment 21
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Tenalisib
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Patients receive Tenalisib 800 mg BID, Orally in 28-Day cycle for 7 cycles

Tenalisib: Tenalisib 800 mg BID, Orally

Period Title: Overall Study
Started 21
Completed 21
Not Completed 0
Arm/Group Title Tenalisib
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Patients receive Tenalisib 800 mg BID, Orally in 28-Day cycle for 7 cycles

Tenalisib: Tenalisib 800 mg BID, Orally

Overall Number of Baseline Participants 21
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[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants
<=18 years
0
   0.0%
Between 18 and 65 years
10
  47.6%
>=65 years
11
  52.4%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 21 participants
66.08
(44.93 to 79.27)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants
Female
3
  14.3%
Male
18
  85.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
21
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 21 participants
Poland 9
Georgia 9
Bulgaria 3
1.Primary Outcome
Title Overall Response Rate (ORR)
Hide Description 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."
Time Frame 7 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who received at least 1 dose of study medication and provided at least 1 post-baseline efficacy assessment
Arm/Group Title Tenalisib
Hide Arm/Group Description:

Patients receive Tenalisib 800 mg BID, Orally in 28-Day cycle for 7 cycles

Tenalisib: Tenalisib 800 mg BID, Orally

Overall Number of Participants Analyzed 21
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
33.3
(14.59 to 56.97)
2.Primary Outcome
Title Duration of Response (DoR)
Hide Description

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.

Time Frame 7 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who received at least 1 dose of study medication and provide at least post-baseline efficacy assessment
Arm/Group Title Tenalisib
Hide Arm/Group Description:

Patients receive Tenalisib 800 mg BID, Orally in 28-Day cycle for 7 cycles

Tenalisib: Tenalisib 800 mg BID, Orally

Overall Number of Participants Analyzed 21
Median (95% Confidence Interval)
Unit of Measure: days
143
(87 to 148)
3.Secondary Outcome
Title Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE Criteria v5.0
Hide Description 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.
Time Frame 7 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who received at least 1 dose of study medication
Arm/Group Title Tenalisib
Hide Arm/Group Description:

Patients receive Tenalisib 800 mg BID, Orally in 28-Day cycle for 7 cycles

Tenalisib: Tenalisib 800 mg BID, Orally

Overall Number of Participants Analyzed 21
Measure Type: Number
Unit of Measure: participants
15
4.Secondary Outcome
Title Progression Free Survival (PFS)
Hide Description 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.
Time Frame 7 months
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who received at least 1 dose of study medication and provide at least 1 post-baseline efficacy assessment
Arm/Group Title Tenalisib
Hide Arm/Group Description:

Patients receive Tenalisib 800 mg BID, Orally in 28-Day cycle for 7 cycles

Tenalisib: Tenalisib 800 mg BID, Orally

Overall Number of Participants Analyzed 21
Median (Inter-Quartile Range)
Unit of Measure: days
205
(198 to 205)
Time Frame 7 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tenalisib
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Patients receive Tenalisib 800 mg BID, Orally in 28-Day cycle for 7 cycles

Tenalisib: Tenalisib 800 mg BID, Orally

All-Cause Mortality
Tenalisib
Affected / at Risk (%)
Total   2/21 (9.52%)    
Hide Serious Adverse Events
Tenalisib
Affected / at Risk (%) # Events
Total   3/21 (14.29%)    
Blood and lymphatic system disorders   
Anemia   1/21 (4.76%)  1
Infections and infestations   
Pneumonia   2/21 (9.52%)  3
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Tenalisib
Affected / at Risk (%) # Events
Total   15/21 (71.43%)    
Blood and lymphatic system disorders   
Anemia   6/21 (28.57%)  10
Neutropenia   5/21 (23.81%)  18
Thrombocytopenia   2/21 (9.52%)  3
Gastrointestinal disorders   
Diarrhea   2/21 (9.52%)  2
Investigations   
Alanine aminotransferase increased   4/21 (19.05%)  7
Aspartate aminotransferase increased   4/21 (19.05%)  6
Blood alkaline phosphatase increased   2/21 (9.52%)  3
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Prajak Barde MD
Organization: Rhizen Pharmaceuticals
Phone: +41325800175
EMail: pjb@rhizen.com
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Responsible Party: Rhizen Pharmaceuticals SA
ClinicalTrials.gov Identifier: NCT04204057    
Other Study ID Numbers: RP6530-1901
First Submitted: December 4, 2019
First Posted: December 18, 2019
Results First Submitted: July 2, 2021
Results First Posted: July 22, 2021
Last Update Posted: July 23, 2021