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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-28

Study Completion Date

2020-10-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Compassionate Use Study of Tenalisib (RP6530)

NCT03711604

Hematological Malignancies

COMPLETED PHASE1/PHASE2

Efficacy and Safety of Linperlisib in Relapsed/Refractory Large Granular T Lymphocytic Leukemia

NCT06224257

Relapsed/Refractory Large Granular T Lymphocytic Leukemia

RECRUITING PHASE2

Study of Efficacy and Safety of CTL019 in Adult ALL Patients

NCT02167360

B-cell Acute Lymphoblastic Leukemia Relapsed B-cell Acute Lymphoblastic Leukemia Refractory B-cell Acute Lymphoblastic Leukemia

WITHDRAWN PHASE2

Ofatumumab and Dinaciclib in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or B-Cell Prolymphocytic Leukemia

NCT01515176

Chronic Lymphocytic Leukemia Prolymphocytic Leukemia Recurrent Small Lymphocytic Lymphoma +1 more

COMPLETED PHASE1/PHASE2

Study to Evaluate the Safety and Efficacy of the Combination of Tirabrutinib and Idelalisib With and Without Obinutuzumab in Adults With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)

NCT02968563

Chronic Lymphocytic Leukemia

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Leukemia, Lymphocytic, Chronic, B-Cell

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

None (open label)

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Tenalisib

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

Group Type EXPERIMENTAL

Tenalisib

Intervention Type DRUG

Tenalisib 800 mg BID, Orally

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tenalisib

Tenalisib 800 mg BID, Orally

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

RP6530

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

\-

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No