Clinical trial NCT04204057: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Leukemia, Lymphocytic, Chronic, B-Cell
Keywords: Phosphoinositide 3-kinase
Pi3k Delta and gamma inhibitor
Tenalisib
Leukemia, Lymphocytic, Chronic, B-Cell
Lead sponsor: Rhizen Pharmaceuticals SA
Sponsor class: INDUSTRY
First posted: 2019-12-18
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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.

Eligibility 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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Primary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: 7 Months
measure: Duration of Response (DoR)
timeFrame: 7 Months
Secondary outcomes:
measure: Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE Criteria v5.0
timeFrame: 7 Months
measure: Progression Free Survival (PFS)
timeFrame: 7 months
Other outcomes:
Locations:
city: Pleven
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment "Dr Georgi Stranski" Ltd.,
city: Sofia
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment "Sv Ivan Rilski" Ltd
city: Tbilisi
country: Georgia
facility: Ltd. M.Zodelava Hematology Centre
city: Tbilisi
country: Georgia
facility: Medivest - Institute of Hematology and Transfusiology
city: Chorzow
country: Poland
facility: Silesian Healthy Blood Clinic Grosicki, Grosicka Sp.J.
city: Łódź
country: Poland
facility: Voivodship Multi-Specialist Center for Oncology and Traumatology M. Copernicus
Study officials:
References: