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

Primary Purpose

Leukemia, Lymphocytic, Chronic, B-Cell

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Tenalisib
Sponsored by
Rhizen Pharmaceuticals SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia, Lymphocytic, Chronic, B-Cell focused on measuring Phosphoinositide 3-kinase, Pi3k Delta and gamma inhibitor, Tenalisib, Leukemia, Lymphocytic, Chronic, B-Cell

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients with diagnosis of B-cell CLL
  2. Disease status defined as refractory to or relapsed after at least one prior therapy.
  3. Presence of measurable lymphadenopathy presence of > 1 nodal lesion
  4. ECOG performance status ≤ 2.
  5. Adequate bone marrow, liver, and renal function

Exclusion Criteria:

  1. Richter's (large cell) transformation, or PLL transformation.
  2. Cancer therapy/ any cancer investigational drug within 3 weeks (21 days) or 5 half-lives (whichever is shorter).
  3. Prior exposure to drug that inhibits PI3K
  4. Patient with ASCT/Allo-SCT receiving treatment for active GVHD.
  5. Ongoing severe systemic bacterial, fungal or viral infection.
  6. Central nervous system (CNS) involvement of leukemia or lymphoma.
  7. Ongoing immunosuppressive therapy including systemic corticosteroids.
  8. Known history of severe liver injury as judge by investigator.
  9. Any severe and/or uncontrolled medical conditions or other conditions that could affect patient participation
  10. Women who are pregnant or lactating.

  11. 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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Sites / Locations

  • University Multiprofile Hospital for Active Treatment "Dr Georgi Stranski" Ltd.,
  • University Multiprofile Hospital for Active Treatment "Sv Ivan Rilski" Ltd
  • Ltd. M.Zodelava Hematology Centre
  • Medivest - Institute of Hematology and Transfusiology
  • Silesian Healthy Blood Clinic Grosicki, Grosicka Sp.J.
  • Voivodship Multi-Specialist Center for Oncology and Traumatology M. Copernicus

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tenalisib

Arm Description

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

Outcomes

Primary Outcome Measures

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."
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
December 4, 2019
Last Updated
July 22, 2021
Sponsor
Rhizen Pharmaceuticals SA
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1. Study Identification

Unique Protocol Identification Number
NCT04204057
Brief Title
Efficacy and Safety of Tenalisib (RP6530) in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL)
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)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
November 28, 2019 (Actual)
Primary Completion Date
October 2, 2020 (Actual)
Study Completion Date
October 2, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rhizen Pharmaceuticals SA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Lymphocytic, Chronic, B-Cell
Keywords
Phosphoinositide 3-kinase, Pi3k Delta and gamma inhibitor, Tenalisib, Leukemia, Lymphocytic, Chronic, B-Cell

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tenalisib
Arm Type
Experimental
Arm Description
Patients receive Tenalisib 800 mg BID, Orally in 28-Day cycle for 7 cycles
Intervention Type
Drug
Intervention Name(s)
Tenalisib
Other Intervention Name(s)
RP6530
Intervention Description
Tenalisib 800 mg BID, Orally
Primary Outcome Measure Information:
Title
Overall Response Rate (ORR)
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
Title
Duration of Response (DoR)
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
Secondary Outcome Measure Information:
Title
Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE Criteria v5.0
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
Title
Progression Free Survival (PFS)
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with diagnosis of B-cell CLL Disease status defined as refractory to or relapsed after at least one prior therapy. Presence of measurable lymphadenopathy presence of > 1 nodal lesion ECOG performance status ≤ 2. Adequate bone marrow, liver, and renal function 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 -
Facility Information:
Facility Name
University Multiprofile Hospital for Active Treatment "Dr Georgi Stranski" Ltd.,
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
University Multiprofile Hospital for Active Treatment "Sv Ivan Rilski" Ltd
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Ltd. M.Zodelava Hematology Centre
City
Tbilisi
Country
Georgia
Facility Name
Medivest - Institute of Hematology and Transfusiology
City
Tbilisi
Country
Georgia
Facility Name
Silesian Healthy Blood Clinic Grosicki, Grosicka Sp.J.
City
Chorzow
ZIP/Postal Code
41-503
Country
Poland
Facility Name
Voivodship Multi-Specialist Center for Oncology and Traumatology M. Copernicus
City
Łódź
Country
Poland

12. IPD Sharing Statement

Learn more about this trial

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

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