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NCT Number: NCT04204057

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

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.

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Key information

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Multiprofile Hospital for Active Treatment "Dr Georgi Stranski" Ltd.,, Pleven, Bulgaria

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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Treatment and study plan

Tenalisib

Drug

Tenalisib 800 mg BID, Orally

Other names: RP6530

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Rhizen Pharmaceuticals SA

Industry

Registry information

Official study 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)

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 18, 2019
Registry last updated
Aug 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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