Peripheral T Cell LymphomaPhase 2NCT05239910
Study to Evaluate the Efficacy and Safety of Tenalisib, Given With CHOP Therapy for Front Line Treatment in Patients With PTCL
A Phase 2 study testing Tenalisib in people with Peripheral T Cell Lymphoma, run by Rhizen Pharmaceuticals SA at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral T Cell Lymphoma
- What is being tested?
- Tenalisib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2023to May 2027
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
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
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.
- Conditions
- Peripheral T Cell Lymphoma
- Being tested
- Tenalisib
- Keywords
- Tenalisib, RP6530, PI3K
- Medical subject headings
- Lymphoma, T-Cell, Peripheral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TenalisibDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Tenalisib 400 mg BID and CHOP | Experimental | Not described Receives: Drug: Tenalisib |
| Tenalisib 800 mg BID and CHOP | Experimental | Not described Receives: Drug: Tenalisib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 9 months
Secondary outcomes (4)
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
Measured: 9 months
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.
Measured: 3 years
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
Measured: 3 years
Overall Survival (OS)
OS is defined as the duration of time from start of treatment to death from any cause.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2022
- Study startJan 2023 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionMay 2027 (estimated)
Why it stopped: Change in development plan
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral T Cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rhizen Pharmaceuticals SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05239910
- Sponsor's protocol ID
- RP6530+CHOP-2103
- Status last verified
- Oct 2022
- First submitted
- 4 Feb 2022
- Last updated
- 17 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05239910
- Acronym / sponsor ID
- RP6530+CHOP-2103
- Conditions
- Peripheral T Cell Lymphoma
- Keywords
- Tenalisib, RP6530, PI3K
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Change in development plan
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rhizen Pharmaceuticals SAIndustry (pharma, biotech, devices)
- Study start
- Jan 2023 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 15 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tenalisib 400 mg BID and CHOP | Experimental | Drug: Tenalisib |
| Tenalisib 800 mg BID and CHOP | Experimental | Drug: Tenalisib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TenalisibTenalisib 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. | Drug | Tenalisib 400 mg BID and CHOP, Tenalisib 800 mg BID and CHOP |
Primary outcome
Complete Response (CR) rate at the end of T-CHOP treatment.
Time frame: 9 months
CR rate is defined as the percentage of patients showing complete response as assessed by the Investigator according to the Lugano Classification.
4 secondary outcomes
Overall Response Rate (ORR) at the end of T-CHOP treatment.
Time frame: 9 months
Duration of Response (DoR),
Time frame: 3 years
Progression-Free Survival (PFS)
Time frame: 3 years
Overall Survival (OS)
Time frame: 3 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tenalisib in people with Peripheral T Cell Lymphoma, run by Rhizen Pharmaceuticals SA at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Response (CR) rate at the end of T-CHOP treatment. (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2022.