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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
Sponsor:
Information provided by (Responsible Party):
Rhizen Pharmaceuticals SA

Tracking Information
First Submitted Date  ICMJE December 4, 2019
First Posted Date  ICMJE December 18, 2019
Results First Submitted Date  ICMJE July 2, 2021
Results First Posted Date  ICMJE July 22, 2021
Last Update Posted Date July 23, 2021
Actual Study Start Date  ICMJE November 28, 2019
Actual Primary Completion Date October 2, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 22, 2021)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 16, 2019)
  • Overall response rate (ORR) [ Time Frame: 7 Months ]
    Overall response rate (ORR): ORR is defined as sum of CR and PR rates as defined by iwCLL guideline for CLL (Hallek et al. 2018).
  • 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 first documentation of definitive disease progression or death from any cause.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 22, 2021)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 16, 2019)
  • Number of participants with treatment related adverse events as assessed by CTCAE criteria v5.0 [ Time Frame: 7 Months ]
    Safety and tolerability of Tenalisib
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Tenalisib (RP6530) in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL)
Official Title  ICMJE 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)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
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)
Primary Purpose: Treatment
Condition  ICMJE Leukemia, Lymphocytic, Chronic, B-Cell
Intervention  ICMJE Drug: Tenalisib
Tenalisib 800 mg BID, Orally
Other Name: RP6530
Study Arms  ICMJE Experimental: Tenalisib
Patients receive Tenalisib 800 mg BID, Orally in 28-Day cycle for 7 cycles
Intervention: Drug: Tenalisib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 2, 2020)
21
Original Estimated Enrollment  ICMJE
 (submitted: December 16, 2019)
61
Actual Study Completion Date  ICMJE October 2, 2020
Actual Primary Completion Date October 2, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

    -

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bulgaria,   Georgia,   Poland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04204057
Other Study ID Numbers  ICMJE RP6530-1901
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rhizen Pharmaceuticals SA
Study Sponsor  ICMJE Rhizen Pharmaceuticals SA
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Rhizen Pharmaceuticals SA
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP