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

NCT04204057 | Completed Phase 2 Results FDA Drug

• 1 other identifier: RP6530-1901
• Study Type: interventional
• Target: 21
• Locations: 3 countries
• Sites: 6

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.

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Keywords

Phosphoinositide 3-kinase; Pi3k Delta and gamma inhibitor; Tenalisib; Leukemia, Lymphocytic, Chronic, B-Cell

Outcome Measures

Primary Outcomes (2)

• Overall Response Rate (ORR)

  Per Response Evaluation Criteria as defined by iwCLL guideline for CLL: Complete Response (CR), all parameters should be regressed to normal (lymph nodes ≥ 1.5 cm; spleen size \<13 cm; liver size normal; no constitutional symptoms; circulating lymphocyte count normal; platelet count ≥ 100 x 109 /L; Hemoglobin ≥ 11.0 g/dL). For partial response, at least two of the parameters (lymph nodes, liver and/or spleen size, constitutional symptoms, circulating lymphocyte count) and one parameter (platelet count, hemoglobin) need to improve if previously abnormal; Overall Response (OR) = CR + PR."

  7 Months

• Duration of Response (DoR)

  Duration of response (DOR): DOR is defined as the interval from the first documentation of CR/PR to the first documentation of definitive disease progression or death from any cause. Progression disease is defined using iwCLL criteria as at least one of the criteria of parameters (i.e., lymph nodes increase ≥ 50% from baseline or from response; liver and/or spleen size increase ≥ 50% from baseline or from response; any constitutional symptoms; circulating lymphocyte count increase ≥ 50% over baseline) or criteria of parameters (i.e., platelet count decrease of ≥ 50% over baseline secondary to CLL; hemoglobin decrease of ≥ 50% over baseline secondary to CLL) should be met.

  7 Months

Secondary Outcomes (2)

• Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE Criteria v5.0

  7 Months

• Progression Free Survival (PFS)

  7 months

Study Arms (1)

Tenalisib

EXPERIMENTAL

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

Drug: Tenalisib

Interventions

Tenalisib DRUG

Tenalisib 800 mg BID, Orally

Also known as: RP6530

Tenalisib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• Any severe and/or uncontrolled medical conditions or other conditions that could affect patient participation
• Women who are pregnant or lactating.
• 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

Sponsors & Collaborators

• Rhizen Pharmaceuticals SA: lead

Study Sites (6)

University Multiprofile Hospital for Active Treatment "Dr Georgi Stranski" Ltd.,

Pleven, 5800, Bulgaria

Location

University Multiprofile Hospital for Active Treatment "Sv Ivan Rilski" Ltd

Sofia, 1431, Bulgaria

Location

Ltd. M.Zodelava Hematology Centre

Tbilisi, Georgia

Location

Medivest - Institute of Hematology and Transfusiology

Tbilisi, Georgia

Location

Silesian Healthy Blood Clinic Grosicki, Grosicka Sp.J.

Chorzów, 41-503, Poland

Location

Voivodship Multi-Specialist Center for Oncology and Traumatology M. Copernicus

Lodz, Poland

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

tenalisib

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Prajak Barde MD
• Organization: Rhizen Pharmaceuticals

pjb@rhizen.com

+41325800175

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: None (open label)
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 4, 2019
• First Posted: December 18, 2019
• Study Start: November 28, 2019
• Primary Completion: October 2, 2020
• Study Completion: October 2, 2020
• Last Updated: August 13, 2024
• Results First Posted: July 22, 2021

Record last verified: 2024-08

Locations

PL (2); BU (2); GE (2)