Non Hodgkin LymphomaPhase 2NCT03711578
Efficacy and Safety Study of Tenalisib (RP6530), a Novel PI3K δ/γ Dual Inhibitor in Patients With Relapsed/Refractory Indolent Non-Hodgkin's Lymphoma (iNHL)
A Phase 2 study testing Tenalisib, in people with Non Hodgkin Lymphoma, run by Rhizen Pharmaceuticals SA at 12 sites in 2 countries.
Trial summary
To assess the anti-tumor activity and safety of Tenalisib in patients with relapsed/refractory indolent Non-Hodgkin's Lymphoma (iNHL), Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Hodgkin 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
- 20 participants
- Where
- 12 sitesin 2 countries
- Study dates
- 25 Nov 2018to 16 Oct 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patients with histologically confirmed diagnosis of indolent B-cell NHL, with histological subtype limited to:
- Follicular lymphoma (FL) G1, G2, or G3a
- Marginal zone lymphoma (MZL) (splenic, nodal, or extra-nodal)
- Lymphoplasmacytic lymphoma/Waldenstrom macroglobulinemia (LPL/WM)
- Small lymphocytic lymphoma (SLL) with absolute lymphocyte count <5 x10^9/L at the time of diagnosis and at study entry.
- Relapsed or refractory after ≥ 2 prior lines of therapy (refractory defined as not responding to a standard regimen or progressing within 6 months of the last course of a standard regimen). Patients must have received rituximab and alkylating agents.
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- Patients must have at least one bi-dimensionally measurable lesion (that has not been previously irradiated) with the longest diameter ≥ 1.5 cm.
- Male or female patients > 18 years of age.
- ECOG performance status ≤ 2.
- Life expectancy of at least 3 months.
- Adequate bone marrow, liver, and renal function as assessed by the following laboratory requirements conducted within 7 days before starting study treatment:
- Hemoglobin ≥ 9 g/dl
- Absolute neutrophil count (ANC) ≥ 1 x 10^9/L
- Platelets ≥50 x 10^9/L (patient without BM involvement) and 30 x 10^9/L (patient with BM involvement)
- Total bilirubin ≤1.5 times the upper limit of normal (ULN)
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 x ULN if known liver involvement
- Creatinine ≤ 1.5 mg/dL OR calculated creatinine clearance ≥ 50 mL/min (as calculated by the Cockcroft-Gault method)
- Use of an effective means of contraception for female patients of child-bearing potential, and all male partners.
- Willingness and ability to comply with trial and follow-up procedures, give written informed consent.
Who cannot join
- FL grade 3b or transformed disease or CLL
- Cancer therapy within 3 weeks (21 days) or 5 half-lives (whichever is shorter) prior to C1D1. Corticosteroids (prednisone or equivalent) at a dose of < 20 mg daily are allowed. Corticosteroid should be stabilized for at least 1 week prior to C1D1
- Auto-SCT within 3 months from C1D1 (patients must not have active graft versus- host disease)
- History of having received an Allo-SCT
- Active hepatitis B or C infection
- Known history of human immunodeficiency virus (HIV) infection
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- Evidence of ongoing severe systemic bacterial, fungal or viral infection
- Known primary central nervous system lymphoma or any preexisting neurologic manifestations
- Known history of drug-induced liver injury, alcoholic liver disease, primary biliary cirrhosis, ongoing extrahepatic obstruction caused by stones, cirrhosis of the liver or portal hypertension;
- Prior exposure to drug that specifically inhibits PI3K
- Pregnancy or lactation
- Myeloid growth factors or red blood cells/ platelet transfusion within 14 days prior to C1D1
- Drug administration within 1 week prior to C1D1
- Strong inhibitors or inducers of CYP3A4, CYP2C9, including grapefruit products, herbal supplements and drugs
- Substrates of CYP3A4 enzyme with a narrow therapeutic range
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
United States8 sites
Tennessee Oncology
Chattanooga, Tennessee, 37404
Colorado Blood Cancer Institute
Denver, Colorado, 80218
Florida cancer specialists & Research Institute
Florida City, Florida, 33401
Florida Cancer Specialist/ South
Fort Myers, Florida, 33908
Clearview Cancer Institute
Huntsville, Alabama, 35805
HCA Midwest Health Kansas City
Kansas City, Missouri, 64132
Tennessee Oncology
Nashville, Tennessee, 37203
Florida Cancer Specialists/North
St. Petersburg, Florida, 33705
Australia4 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Blacktown Hospital, Blacktown Cancer and Haematology Center
Blacktown, New South Wales, 2148
Brisbane Clinic for Lymphoma, Myeloma and Leukaemia,
Greenslopes, Queensland, 4120
John Flynn Private Hospital,
Tugun, Queensland, 4224
About this study
Official title: An Open Label, Phase II Study to Evaluate the Efficacy and Safety of Tenalisib (RP6530), a Novel PI3K δ/γ Dual Inhibitor in Adult Patients With Relapsed/Refractory Indolent Non-Hodgkin's Lymphoma (iNHL)
To assess the anti-tumor activity and safety of Tenalisib in patients with relapsed/refractory indolent Non-Hodgkin's Lymphoma (iNHL),
- Conditions
- Non Hodgkin Lymphoma
- Being tested
- Tenalisib,
- Keywords
- Non-Hodgkin lymphoma,, Tenalisib, RP6530
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenalisib,Drug
Also called RP6530
BID, Orally
| Study group | Role | What they receive |
|---|---|---|
| Tenalisib | Experimental | Participants receive Tenalisib 800 mg BID in 28-Days Cycle for 8 Cycles Receives: Drug: Tenalisib, |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
ORR is defined as sum of CR and PR rates and will be assessed according to the Lugano Classification for initial evaluation, staging, and response assessment of Non-Hodgkin lymphoma. (Cheson-2014)
Measured: 7 months
Complete Response Rate
CR rate will be assessed according to the Lugano Classification for initial evaluation, staging, and response assessment of non-Hodgkin lymphoma.
Measured: 7 months
Progression Free Survival (PFS)
PFS is defined as the time of the first dose of Tenalisib to disease progression or death.
Measured: From date of first dose of tenalisib until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 7 months
Duration of Response (DoR)
DoR is measured from the initial response to disease progression or death
Measured: 7 months
Secondary outcomes (1)
Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v4.0
Safety and tolerability of Tenalisib
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2018
- Study start25 Nov 2018
- Primary completion16 Jun 2020
- Study completion16 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non Hodgkin 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 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
- NCT03711578
- Sponsor's protocol ID
- RP6530-1802
- Status last verified
- Jul 2021
- First submitted
- 15 Oct 2018
- Last updated
- 12 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- 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 12 Aug 2021. 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), a Novel PI3K δ/γ Dual Inhibitor in Adult Patients With Relapsed/Refractory Indolent Non-Hodgkin's Lymphoma (iNHL)
- ClinicalTrials.gov ID
- NCT03711578
- Acronym / sponsor ID
- RP6530-1802
- Conditions
- Non Hodgkin Lymphoma
- Keywords
- Non-Hodgkin lymphoma,, Tenalisib, RP6530
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Rhizen Pharmaceuticals SAIndustry (pharma, biotech, devices)
- Study start
- 25 Nov 2018 (actual)
- Primary completion
- 16 Jun 2020 (actual)
- Study completion
- 16 Oct 2020 (actual)
- First posted
- 18 Oct 2018 (actual)
- Results
- Posted 12 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the anti-tumor activity and safety of Tenalisib in patients with relapsed/refractory indolent Non-Hodgkin's Lymphoma (iNHL),
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tenalisib | Experimental | Drug: Tenalisib,Participants receive Tenalisib 800 mg BID in 28-Days Cycle for 8 Cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Patients with histologically confirmed diagnosis of indolent B-cell NHL, with histological subtype limited to:
- Relapsed or refractory after ≥ 2 prior lines of therapy (refractory defined as not responding to a standard regimen or progressing within 6 months of the last course of a standard regimen). Patients must have received rituximab and alkylating agents.
- Patients must have at least one bi-dimensionally measurable lesion (that has not been previously irradiated) with the longest diameter ≥ 1.5 cm.
- Male or female patients > 18 years of age.
- ECOG performance status ≤ 2.
Key exclusion criteria (15 listed)
- FL grade 3b or transformed disease or CLL
- Cancer therapy within 3 weeks (21 days) or 5 half-lives (whichever is shorter) prior to C1D1. Corticosteroids (prednisone or equivalent) at a dose of < 20 mg daily are allowed. Corticosteroid should be stabilized for at least 1 week prior to C1D1
- Auto-SCT within 3 months from C1D1 (patients must not have active graft versus- host disease)
- History of having received an Allo-SCT
- Active hepatitis B or C infection
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 |
|---|---|---|
| Tenalisib,Also: RP6530BID, Orally | Drug | Tenalisib |
Primary outcome
Objective Response Rate (ORR)
Time frame: 7 months
ORR is defined as sum of CR and PR rates and will be assessed according to the Lugano Classification for initial evaluation, staging, and response assessment of Non-Hodgkin lymphoma. (Cheson-2014)
Complete Response Rate
Time frame: 7 months
CR rate will be assessed according to the Lugano Classification for initial evaluation, staging, and response assessment of non-Hodgkin lymphoma.
Progression Free Survival (PFS)
Time frame: From date of first dose of tenalisib until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 7 months
PFS is defined as the time of the first dose of Tenalisib to disease progression or death.
Duration of Response (DoR)
Time frame: 7 months
DoR is measured from the initial response to disease progression or death
1 secondary outcome
Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v4.0
Time frame: 8 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
12 sites in 2 countries: 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 Non Hodgkin Lymphoma, run by Rhizen Pharmaceuticals SA at 12 sites in 2 countries.
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 19 inclusion and 15 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: finished, as of the sponsor's last update on 12 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Australia. 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?
Yes. Results are posted in the registry (first posted 12 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Objective Response Rate (ORR) (time frame: 7 months). The study lists 4 primary outcomes in all. 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 12 Aug 2021.