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

R

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)

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

Trial documents
2

Trial contacts and locations

6

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Data sourced from clinicaltrials.gov

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