Indolent Non-hodgkin LymphomaPhase 2NCT04298879
IBI376 in Patients With Relapsed or Refractory Follicular Lymphoma/Marginal Zone Lymphoma
A Phase 2 study testing IBI376 in people with Indolent Non-hodgkin Lymphoma, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
Trial summary
A Phase 2, Multicenter, Open-Label Study of IBI376, a PI3Kδ Inhibitor, in Patients with Relapsed or Refractory Follicular Lymphoma/Marginal Zone Lymphoma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Indolent Non-hodgkin Lymphoma
- What is being tested?
- IBI376
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteChina
- Study dates
- 7 Apr 2020to 21 Nov 2023
- 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
- Aged 18 years or older.
- Histologically confirmed, relapsed or refractory, follicular B-cell non-Hodgkin lymphoma (NHL) (FL) Grade 1, 2, and 3a or MZL.
- Ineligible for hematopoietic stem cell transplant.
- Definition of RRFL or RRMZL: Subjects should have received 2 or more prior therapies for FL/MZL included at least one regimen containing Rituximab. Subjects should be refractory to Rituximab or experienced disease progression after achieved remission or disease progression within 6 months since last therapy.
- Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined as the presence of ≥ 1 lesion that measures > 1.5 cm in the longest dimension and ≥ 1.0 cm in the longest perpendicular dimension as assessed by computed tomography (CT) or magnetic resonance imaging (MRI).
- Subjects must be willing to undergo an incisional, excisional, or core needle lymph node or tissue biopsy or provide a lymph node or tissue biopsy from the most recent available archival tissue.
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- ECOG performance status 0 to 2.
- Life expectancy ≥ 12 weeks.
- Adequate hematologic, hepatic, and renal function.
- Willingness to avoid pregnancy or fathering children.
Who cannot join
- 1 . Known histological transformation from indolent NHL to diffuse large B-cell lymphoma.
- 2. History of central nervous system lymphoma (either primary or metastatic).
- 3. Prior treatment with idelalisib, other selective PI3Kδ inhibitors, or a pan-PI3K inhibitor.
- 4. Prior treatment with a Bruton's tyrosine kinase inhibitor (eg, ibrutinib).
- 5. Allogeneic stem cell transplant within the last 6 months, or autologous stem cell transplant within the last 3 months before the date of study treatment administration.
- 6. Active graft-versus-host disease. 7. Subjects positive for hepatitis B surface antigen or hepatitis B core antibody will be eligible if they are negative for HBV-DNA. Subjects positive for anti-HCV antibody will be eligible if they are negative for HCV-RNA.
Trial locations and contacts
1 site in 1 country.
China1 site
Ruijin hospital, school of medicine, Shanghai jiao tong university
Shanghai
About this study
Official title: A Phase 2, Multicenter, Open-Label Study of IBI376, a PI3Kδ Inhibitor, in Patients With Relapsed or Refractory Follicular Lymphoma/Marginal Zone Lymphoma
A Phase 2, Multicenter, Open-Label Study of IBI376, a PI3Kδ Inhibitor, in Patients with Relapsed or Refractory Follicular Lymphoma/Marginal Zone Lymphoma
Read the detailed description
Patients will be recruited for 2 cohorts. Cohort A will recruit 58 RRFL subjects, and Cohort B will recruit 62 RRMZL subjects.
- Conditions
- Indolent Non-hodgkin Lymphoma
- Being tested
- IBI376
- Keywords
- Follicular Lymphoma, Marginal Zone Lymphoma, Parsaclisib
- Medical subject headings
- Lymphoma, Follicular, Lymphoma, B-Cell, Marginal Zone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBI376Drug
Also called Parsaclisib
IBI376 20 mg po. once daily for 8 weeks ，followed by 2.5mg once daily
| Study group | Role | What they receive |
|---|---|---|
| IBI376 | Experimental | IBI376 will be administered orally at a dose of 20 mg once daily for 8 weeks followed by 2.5 mg once daily. Receives: Drug: IBI376 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
To assess the efficacy of IBI376 in terms of objective response rate (ORR) in subjects with relapsed or refractory follicular lymphoma (FL)/Marginal lymphoma(MZL). Subjects will be evaluated for ORR by an IRC (Lugano criteria)
Measured: 2 years
Secondary outcomes (6)
Complete Response Rate (CRR)
To assess complete response rate (CRR)
Measured: 2 years
Duration of Response (DOR)
To assess the duration of response (DOR)
Measured: 2 years
Progression-free Survival (PFS)
To assess progression-free survival (PFS)
Measured: 2 years
Overall Survival (OS)
To assess overall survival (OS)
Measured: 2 years
Best percentage change in target lesion size
To assess best percentage change in target lesion size
Measured: 2 years
Safety and tolerability of IBI376 measured by adverse events (AEs)
Defined as any AE either reported for the first time or worsening of a pre-existing event after first dose of study treatment.
Measured: Baseline through 30-35 days after end of treatment, up to approximately 12 months per subject
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2020
- Study start7 Apr 2020
- Primary completion27 Jul 2021
- Study completion21 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Indolent Non-hodgkin LymphomaStudies of the same condition, open and under way.
- More trials run by Innovent Biologics (Suzhou) Co. Ltd.The sponsor's other registered studies.
- 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
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04298879
- Sponsor's protocol ID
- CIBI376A201
- Status last verified
- Jun 2024
- First submitted
- 2 Mar 2020
- Last updated
- 5 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Open-Label Study of IBI376, a PI3Kδ Inhibitor, in Patients With Relapsed or Refractory Follicular Lymphoma/Marginal Zone Lymphoma
- ClinicalTrials.gov ID
- NCT04298879
- Acronym / sponsor ID
- CIBI376A201
- Conditions
- Indolent Non-hodgkin Lymphoma
- Keywords
- Follicular Lymphoma, Marginal Zone Lymphoma, Parsaclisib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Apr 2020 (actual)
- Primary completion
- 27 Jul 2021 (actual)
- Study completion
- 21 Nov 2023 (actual)
- First posted
- 6 Mar 2020 (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.
A Phase 2, Multicenter, Open-Label Study of IBI376, a PI3Kδ Inhibitor, in Patients with Relapsed or Refractory Follicular Lymphoma/Marginal Zone Lymphoma
Detailed description
Patients will be recruited for 2 cohorts. Cohort A will recruit 58 RRFL subjects, and Cohort B will recruit 62 RRMZL subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IBI376 | Experimental | Drug: IBI376IBI376 will be administered orally at a dose of 20 mg once daily for 8 weeks followed by 2.5 mg once daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Aged 18 years or older.
- Histologically confirmed, relapsed or refractory, follicular B-cell non-Hodgkin lymphoma (NHL) (FL) Grade 1, 2, and 3a or MZL.
- Ineligible for hematopoietic stem cell transplant.
- Definition of RRFL or RRMZL: Subjects should have received 2 or more prior therapies for FL/MZL included at least one regimen containing Rituximab. Subjects should be refractory to Rituximab or experienced disease progression after achieved remission or disease progression within 6 months since last therapy.
- Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined as the presence of ≥ 1 lesion that measures > 1.5 cm in the longest dimension and ≥ 1.0 cm in the longest perpendicular dimension as assessed by computed tomography (CT) or magnetic resonance imaging (MRI).
Key exclusion criteria (6 listed)
- 1 . Known histological transformation from indolent NHL to diffuse large B-cell lymphoma.
- 2. History of central nervous system lymphoma (either primary or metastatic).
- 3. Prior treatment with idelalisib, other selective PI3Kδ inhibitors, or a pan-PI3K inhibitor.
- 4. Prior treatment with a Bruton's tyrosine kinase inhibitor (eg, ibrutinib).
- 5. Allogeneic stem cell transplant within the last 6 months, or autologous stem cell transplant within the last 3 months before the date of study treatment administration.
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 |
|---|---|---|
| IBI376Also: ParsaclisibIBI376 20 mg po. once daily for 8 weeks ，followed by 2.5mg once daily | Drug | IBI376 |
Primary outcome
Objective Response Rate (ORR)
Time frame: 2 years
To assess the efficacy of IBI376 in terms of objective response rate (ORR) in subjects with relapsed or refractory follicular lymphoma (FL)/Marginal lymphoma(MZL). Subjects will be evaluated for ORR by an IRC (Lugano criteria)
6 secondary outcomes
Complete Response Rate (CRR)
Time frame: 2 years
Duration of Response (DOR)
Time frame: 2 years
Progression-free Survival (PFS)
Time frame: 2 years
Overall Survival (OS)
Time frame: 2 years
Best percentage change in target lesion size
Time frame: 2 years
Safety and tolerability of IBI376 measured by adverse events (AEs)
Time frame: Baseline through 30-35 days after end of treatment, up to approximately 12 months per subject
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2024.
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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 IBI376 in people with Indolent Non-hodgkin Lymphoma, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
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 10 inclusion and 6 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 5 Jun 2024. 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 China. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: 2 years). 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 5 Jun 2024.