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

Rhizen Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Leukemia, Lymphocytic, Chronic, B-Cell

Treatments: Drug: Tenalisib

Study type: Interventional

Funder types: Industry

Identifiers

NCT04204057

RP6530-1901

Details and patient eligibility

About

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.

Full 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.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

Tenalisib

Experimental group

Description:

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

Treatment:

Drug: Tenalisib