Follicular LymphomaPhase 1NCT05867030
Parsaclisib in Patients With Relapsed or Refractory Follicular Lymphoma
A Phase 1 study testing lenalidomide, rituximab and parsaclisib in people with Follicular Lymphoma, run by Innovent Biologics (Suzhou) Co. Ltd..
Trial summary
A Phase Ib/III, Multicenter, double-blinded study of Parsaclisib, a PI3Kδ Inhibitor, in Patients with Relapsed or Refractory Follicular Lymphoma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Follicular Lymphoma
- What is being tested?
- lenalidomide, rituximab and parsaclisib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 28 Jul 2023to 30 Apr 2033
- Phase
- Phase 1
- 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
- Age ≥18 years old.
- Histopathological diagnosis as FL Grade1, 2 or 3a
- The patient is not suitable or refuse the hematopoietic stem cell transplantation(HSCT).
- Presence of radiographically measurable lymph nodes or extranodal lesions, defined as at least one lesion longest diameter (LD) measurements > 1.5 cm and longest vertical diameter (LPD) measurements ≥1.0 cm.
- Life expectancy ≥12 weeks.
Who cannot join
- Known histological transformation of diffuse large B-cell lymphoma (DLBCL) from indolent non-Hodgkin lymphoma (iNHL).
- A history of central nervous system lymphoma (primary or metastatic) and leptomeninges dease.
- Previously received Idelalisib, other selective PI3Kδ inhibitors or generic PI3K inhibitor treatment.
- Previously received Bruton tyrosine kinase inhibitors (e.g., ibrutinib).
- pregnant or lactating women.
About this study
Official title: A Phase Ib/III Study to Evaluating the Efficacy and Safety of Parsaclisib in Combination With Rituximab and Lenalidomide Versus Rituximab in Combination With Lenalidomide in Subjects With Relapsed or Refractory Follicular Lymphoma
A Phase Ib/III, Multicenter, double-blinded study of Parsaclisib, a PI3Kδ Inhibitor, in Patients with Relapsed or Refractory Follicular Lymphoma
- Conditions
- Follicular Lymphoma
- Being tested
- lenalidomide, rituximab, parsaclisib
- Medical subject headings
- Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lenalidomideDrug
Also called Lainamei
lenalidomide is administered orally
rituximabDrug
Also called Halpryza
rituximab is administered intravenously
parsaclisibDrug
Also called IBI376
parsaclisib is administered orally
| Study group | Role | What they receive |
|---|---|---|
| Parsaclisib+rituximab | Experimental | parsaclisib（2.5 mg QD，D1~D14/ per28 days）+rituximab ( 375mg/m2, IV, C1D1\D8\D15\D22, C2D1\C3D1\C4D1\C5D1). Receives: Drug: rituximab; Drug: parsaclisib |
| Parsaclisib+rituximab + lenalidomide | Experimental | parsaclisib（2.5 mg QD，D1~D14/ per28 days）+rituximab( 375mg/m2, IV, C1D1\D8\D15\D22, C2D1\C3D1\C4D1\C5D1)+lenalidomide( 20mg PO, D1-D21/Cycle, no more than 12cycles). Receives: Drug: lenalidomide; Drug: rituximab; Drug: parsaclisib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects with a complete response (CR) at the best overall response (BOR) assessed by the investigators (Complete Response Rate , CRR)
Measured: within 6 months after last patient enrolled, an average of 2 years
The incidence of treatment-emergent adverse event (TEAE) and the incidence of adverse events of special interest (AESI) leading to permanent discontinuation and/or dose-reduction
Measured: within 6 months after last patient enrolled, an average of 2 years
The duration from randomization to disease progression as assessed by an Independent Evaluation Committee (IRC) according to the revised Lymphoma Response Evaluation Criteria (Lugano 2014 criteria) or all-cause death.
Measured: up to all subjects reached PFS endpoint, an average of 5 year
Secondary outcomes (2)
The incidence of treatment-emergent adverse event (TEAE) and the incidence of adverse events of special interest (AESI) leading to permanent discontinuation and/or dose-reduction
Measured: within 12 months after last patient enrolled, an average of 2.5 years
Percentage of subjects achieving CR or PR in the analysis population evaluated by IRC or investigator according to the Lugano 2014 criteria.
Measured: Up to all subjects complete the study treatment, an average of 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start28 Jul 2023 (estimated)
- Primary completion31 Aug 2029 (estimated)
- Study completion30 Apr 2033 (estimated)
Why it stopped: Development strategy adjustment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Follicular 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 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
- NCT05867030
- Sponsor's protocol ID
- CIBI376A301
- Status last verified
- Oct 2023
- First submitted
- 10 Apr 2023
- Last updated
- 17 Oct 2023
- 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 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/III Study to Evaluating the Efficacy and Safety of Parsaclisib in Combination With Rituximab and Lenalidomide Versus Rituximab in Combination With Lenalidomide in Subjects With Relapsed or Refractory Follicular Lymphoma
- ClinicalTrials.gov ID
- NCT05867030
- Acronym / sponsor ID
- CIBI376A301
- Conditions
- Follicular Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Development strategy adjustment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Jul 2023 (estimated)
- Primary completion
- 31 Aug 2029 (estimated)
- Study completion
- 30 Apr 2033 (estimated)
- First posted
- 19 May 2023 (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 Ib/III, Multicenter, double-blinded study of Parsaclisib, a PI3Kδ Inhibitor, in Patients with Relapsed or Refractory Follicular Lymphoma
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parsaclisib+rituximab | Experimental | Drug: rituximab, Drug: parsaclisibparsaclisib（2.5 mg QD，D1~D14/ per28 days）+rituximab ( 375mg/m2, IV, C1D1\D8\D15\D22, C2D1\C3D1\C4D1\C5D1). |
| Parsaclisib+rituximab + lenalidomide | Experimental | Drug: lenalidomide, Drug: rituximab, Drug: parsaclisibparsaclisib（2.5 mg QD，D1~D14/ per28 days）+rituximab( 375mg/m2, IV, C1D1\D8\D15\D22, C2D1\C3D1\C4D1\C5D1)+lenalidomide( 20mg PO, D1-D21/Cycle, no more than 12cycles). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years old.
- Histopathological diagnosis as FL Grade1, 2 or 3a
- The patient is not suitable or refuse the hematopoietic stem cell transplantation(HSCT).
- Presence of radiographically measurable lymph nodes or extranodal lesions, defined as at least one lesion longest diameter (LD) measurements > 1.5 cm and longest vertical diameter (LPD) measurements ≥1.0 cm.
- Life expectancy ≥12 weeks.
Key exclusion criteria (5 listed)
- Known histological transformation of diffuse large B-cell lymphoma (DLBCL) from indolent non-Hodgkin lymphoma (iNHL).
- A history of central nervous system lymphoma (primary or metastatic) and leptomeninges dease.
- Previously received Idelalisib, other selective PI3Kδ inhibitors or generic PI3K inhibitor treatment.
- Previously received Bruton tyrosine kinase inhibitors (e.g., ibrutinib).
- pregnant or lactating women.
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 |
|---|---|---|
| lenalidomideAlso: Lainameilenalidomide is administered orally | Drug | Parsaclisib+rituximab + lenalidomide |
| rituximabAlso: Halpryzarituximab is administered intravenously | Drug | Parsaclisib+rituximab, Parsaclisib+rituximab + lenalidomide |
| parsaclisibAlso: IBI376parsaclisib is administered orally | Drug | Parsaclisib+rituximab, Parsaclisib+rituximab + lenalidomide |
Primary outcome
Percentage of subjects with a complete response (CR) at the best overall response (BOR) assessed by the investigators (Complete Response Rate , CRR)
Time frame: within 6 months after last patient enrolled, an average of 2 years
The incidence of treatment-emergent adverse event (TEAE) and the incidence of adverse events of special interest (AESI) leading to permanent discontinuation and/or dose-reduction
Time frame: within 6 months after last patient enrolled, an average of 2 years
The duration from randomization to disease progression as assessed by an Independent Evaluation Committee (IRC) according to the revised Lymphoma Response Evaluation Criteria (Lugano 2014 criteria) or all-cause death.
Time frame: up to all subjects reached PFS endpoint, an average of 5 year
2 secondary outcomes
The incidence of treatment-emergent adverse event (TEAE) and the incidence of adverse events of special interest (AESI) leading to permanent discontinuation and/or dose-reduction
Time frame: within 12 months after last patient enrolled, an average of 2.5 years
Percentage of subjects achieving CR or PR in the analysis population evaluated by IRC or investigator according to the Lugano 2014 criteria.
Time frame: Up to all subjects complete the study treatment, an average of 5 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 2023.
Related trials for Follicular Lymphoma
RecruitingPhase 1/2
A Platform Trial Evaluating New Drugs or Combination in R/R Peripheral T-cell Lymphomas
Peripheral T Cells Lymphoma (PTCL), Follicular Helper T-Cell Lymphoma
Active, not recruiting
EXHIT ENTRE Implementation Trial of High Intensity Versus Low Intensity Strategy
Substance Use Disorders, Opioid Use Disorder, Severe
RecruitingPhase 1/2
Dose Escalation and Dose Expansion Study of MDX2003 in Patients With Different Types of Lymphoma
Lymphoma, Waldenström Macroglobulinemia (WM)
Active, not recruitingPhase 1
A Rollover Study of CC-122
Non-Hodgkin Lymphoma
Recruiting
STEpwise Research Program to Promote INGeniouS ONline Supportive Solutions in the Relief of Cancer-related Fatigue
Cancer Diagnosis, Moderate or Severe Score of Cancer-related Fatigue (CRF)
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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing lenalidomide, rituximab and parsaclisib in people with Follicular Lymphoma, run by Innovent Biologics (Suzhou) Co. Ltd..
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 5 inclusion and 5 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 2023. Status can change between updates, so confirm with the study contact before making plans.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Percentage of subjects with a complete response (CR) at the best overall response (BOR) assessed by the investigators (Complete Response Rate , CRR) (time frame: within 6 months after last patient enrolled, an average of 2 years). The study lists 3 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 17 Oct 2023.