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Trial record 1 of 1 for:    Efficacy and Safety of Tenalisib (RP6530) in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL)
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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

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.

Condition or disease Intervention/treatment Phase
Leukemia, Lymphocytic, Chronic, B-Cell Drug: Tenalisib Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
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
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia

Arm Intervention/treatment
Experimental: Tenalisib
Patients receive Tenalisib 800 mg BID, Orally in 28-Day cycle for 7 cycles
Drug: Tenalisib
Tenalisib 800 mg BID, Orally
Other Name: RP6530




Primary Outcome Measures :
  1. 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."

  2. 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.



Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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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Information from the National Library of Medicine

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


Locations
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Bulgaria
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
Georgia
Ltd. M.Zodelava Hematology Centre
Tbilisi, Georgia
Medivest - Institute of Hematology and Transfusiology
Tbilisi, Georgia
Poland
Silesian Healthy Blood Clinic Grosicki, Grosicka Sp.J.
Chorzow, Poland, 41-503
Voivodship Multi-Specialist Center for Oncology and Traumatology M. Copernicus
Łódź, Poland
Sponsors and Collaborators
Rhizen Pharmaceuticals SA
  Study Documents (Full-Text)

Documents provided by Rhizen Pharmaceuticals SA:
Study Protocol  [PDF] September 12, 2019
Statistical Analysis Plan  [PDF] December 14, 2020

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Responsible Party: Rhizen Pharmaceuticals SA
ClinicalTrials.gov Identifier: NCT04204057    
Other Study ID Numbers: RP6530-1901
First Posted: December 18, 2019    Key Record Dates
Results First Posted: July 22, 2021
Last Update Posted: July 23, 2021
Last Verified: July 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rhizen Pharmaceuticals SA:
Phosphoinositide 3-kinase
Pi3k Delta and gamma inhibitor
Tenalisib
Leukemia, Lymphocytic, Chronic, B-Cell
Additional relevant MeSH terms:
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Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell