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Study to Evaluate the Efficacy and Safety of Tenalisib, Given With CHOP Therapy for Front Line Treatment in Patients With PTCL

Primary Purpose

Peripheral T Cell Lymphoma

Status

Withdrawn

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Tenalisib

About this trial

This is an interventional treatment trial for Peripheral T Cell Lymphoma focused on measuring Tenalisib, RP6530, PI3K

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Provision of full informed consent prior to any study-specific procedures.
Pathologically confirmed diagnosis of PTCL according to WHO 2016 classification criteria EXCEPT following subtypes:
- ALK-positive anaplastic T-cell lymphoma; CD30+ PTCL (who are eligible for BV and CHOP combination); extra-nodal NK/T-cell lymphoma, nasal type; HTLV1- associated lymphoma; primary cutaneous anaplastic T-cell lymphoma, T-cell lymphoma with only skin involvement
Disease status is defined as treatment naïve patients with PTCL who have not received prior systemic therapy for lymphoma.
Must have ECOG performance status ≤ 2
Patients must have measurable disease defined as at least one bi-dimensional measurable lesion assessed radiologically with a minimum measurement of > 1.5 cm in the longest diameter.
Patients must be fit to receive full-dose CHOP Therapy.
Adequate bone marrow, liver and renal functions

Exclusion Criteria:

Patients who have received prior systemic therapy for lymphoma or are receiving anticancer therapy including any investigational therapy (e.g., chemotherapy, biologic therapy, hormonal therapy).
Patients with known Central Nervous System (CNS) lymphoma or CNS involvement by lymphoma.
Active uncontrolled systemic fungal, bacterial or viral infection
Patient with ongoing or significant cardiac disease in last 6 months which according to the investigator can impact study participation
Patients with co-morbidities/complications
Known history of severe liver injury/disease
Active viral infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C. and history of severe cutaneous reactions
Patient with any other active malignancy at the time of screening except for adequately treated in situ carcinoma of the cervix uteri or carcinoma in situ of breast, basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin,
Hypersensitivity to the active substance or to any of the excipients.
Pregnancy or lactation.
Concurrent medications or substance, the example of these treatment includes strong inhibitors or inducer of CYP3A4 enzyme or substrate of CYP3A4 with narrow therapeutic index.

Sites / Locations

The University of Texas MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Tenalisib 400 mg BID and CHOP

Tenalisib 800 mg BID and CHOP

Arm Description

Outcomes

Primary Outcome Measures

Complete Response (CR) rate at the end of T-CHOP treatment.

CR rate is defined as the percentage of patients showing complete response as assessed by the Investigator according to the Lugano Classification.

Secondary Outcome Measures

Overall Response Rate (ORR) at the end of T-CHOP treatment.

ORR is defined as sum of CR and PR rates, as assessed by the Investigator according to the Lugano Classification

Duration of Response (DoR),

The duration of response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented.

Progression-Free Survival (PFS)

PFS is defined as the duration of time from start of treatment to time of documentation of progression or death from any cause

Overall Survival (OS)

OS is defined as the duration of time from start of treatment to death from any cause.

Full Information

NCT ID

NCT05239910

First Posted

February 4, 2022

Last Updated

October 13, 2022

Sponsor

Rhizen Pharmaceuticals SA

1. Study Identification

Unique Protocol Identification Number

NCT05239910

Brief Title

Study to Evaluate the Efficacy and Safety of Tenalisib, Given With CHOP Therapy for Front Line Treatment in Patients With PTCL

Official Title

An Open Label, Phase II Study to Evaluate the Efficacy and Safety of Tenalisib (RP6530), Given With Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) Therapy for Front Line Treatment in Patients With Peripheral T-cell Lymphoma

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Withdrawn

Why Stopped

Change in development plan

Study Start Date

January 2023 (Anticipated)

Primary Completion Date

December 2026 (Anticipated)

Study Completion Date

May 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Rhizen Pharmaceuticals SA

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This is a phase II open label, two-arm parallel design study of T-CHOP in patients with treatment naïve PTCL. Two doses of tenalisib (400 mg BID and 800 mg BID) will be evaluated in separate groups (Group 1: 400 mg BID and Group 2: 800mg BID) when given with standard regimen of CHOP, followed by single agent maintenance treatment with tenalisib for 1 year. Recruitment of 20 patients each will be done in both groups in parallel. All eligible patients will start with a run-in period, in which single agent tenalisib will be administered for 3 cycles of 21 days each. Post run-in period, all patients will proceed to receive tenalisib and CHOP regimen for next 6 cycles. After completion of 6 cycles of T-CHOP treatment, maintenance therapy with tenalisib will be initiated in patients showing CR and PR. These patients will continue to receive single agent tenalisib for 1 year.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peripheral T Cell Lymphoma

Keywords

Tenalisib, RP6530, PI3K

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tenalisib 400 mg BID and CHOP

Arm Type

Experimental

Arm Title

Tenalisib 800 mg BID and CHOP

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Tenalisib

Intervention Description

Tenalisib will be administered orally twice daily in a 21-day cycle for 26 cycles (from cycle 1 to cycle 26), CHOP will be administered for 6 cycles (from Cycle 4 to Cycle 9) on Days 1 to 5 of each cycle.

Primary Outcome Measure Information:

Title

Complete Response (CR) rate at the end of T-CHOP treatment.

Description

CR rate is defined as the percentage of patients showing complete response as assessed by the Investigator according to the Lugano Classification.

Time Frame

9 months

Secondary Outcome Measure Information:

Title

Overall Response Rate (ORR) at the end of T-CHOP treatment.

Description

ORR is defined as sum of CR and PR rates, as assessed by the Investigator according to the Lugano Classification

Time Frame

9 months

Title

Duration of Response (DoR),

Description

Time Frame

3 years

Title

Progression-Free Survival (PFS)

Description

PFS is defined as the duration of time from start of treatment to time of documentation of progression or death from any cause

Time Frame

3 years

Title

Overall Survival (OS)

Description

OS is defined as the duration of time from start of treatment to death from any cause.

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Provision of full informed consent prior to any study-specific procedures. Pathologically confirmed diagnosis of PTCL according to WHO 2016 classification criteria EXCEPT following subtypes: ALK-positive anaplastic T-cell lymphoma; CD30+ PTCL (who are eligible for BV and CHOP combination); extra-nodal NK/T-cell lymphoma, nasal type; HTLV1- associated lymphoma; primary cutaneous anaplastic T-cell lymphoma, T-cell lymphoma with only skin involvement Disease status is defined as treatment naïve patients with PTCL who have not received prior systemic therapy for lymphoma. Must have ECOG performance status ≤ 2 Patients must have measurable disease defined as at least one bi-dimensional measurable lesion assessed radiologically with a minimum measurement of > 1.5 cm in the longest diameter. Patients must be fit to receive full-dose CHOP Therapy. Adequate bone marrow, liver and renal functions Exclusion Criteria: Patients who have received prior systemic therapy for lymphoma or are receiving anticancer therapy including any investigational therapy (e.g., chemotherapy, biologic therapy, hormonal therapy). Patients with known Central Nervous System (CNS) lymphoma or CNS involvement by lymphoma. Active uncontrolled systemic fungal, bacterial or viral infection Patient with ongoing or significant cardiac disease in last 6 months which according to the investigator can impact study participation Patients with co-morbidities/complications Known history of severe liver injury/disease Active viral infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C. and history of severe cutaneous reactions Patient with any other active malignancy at the time of screening except for adequately treated in situ carcinoma of the cervix uteri or carcinoma in situ of breast, basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin, Hypersensitivity to the active substance or to any of the excipients. Pregnancy or lactation. Concurrent medications or substance, the example of these treatment includes strong inhibitors or inducer of CYP3A4 enzyme or substrate of CYP3A4 with narrow therapeutic index.

Facility Information:

Facility Name

The University of Texas MD Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Study to Evaluate the Efficacy and Safety of Tenalisib, Given With CHOP Therapy for Front Line Treatment in Patients With PTCL

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