CompletedPhase 2

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

Bulgaria, Georgia, Poland21 participantsStarted 2019-11-28

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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.

What they're measuring

Overall Response Rate (ORR)

Timeframe: 7 Months

Duration of Response (DoR)

Timeframe: 7 Months

Trial details

NCT IDNCT04204057

SponsorRhizen Pharmaceuticals SA

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-10-02

Results submitted2021-07-02

View on ClinicalTrials.gov More Leukemia, Lymphocytic, Chronic, B-Cell trials