Mantle Cell LymphomaPhase 2NCT06324994
Linperlisib Plus Obinutuzumab and Venetoclax for Relapsed and Refractory Blastoid Variant of Mantle Cell Lymphoma.
A Phase 2 study testing Linperlisib in combination with Obinutuzumab and Venetoclax in people with Mantle Cell Lymphoma, run by Dalian Medical University at 1 site in China.
Trial summary
This is a single arm, open label, national multicenter clinical study included patients with relapsed and refractory blastoid variant of mantle cell lymphoma (R/R BV-MCL), aiming to evaluate the efficacy of a chemotherapy free triple therapy of PI3K inhibitor (Linperlisib) combined with anti-CD20 monoclonal antibody… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mantle Cell Lymphoma
- What is being tested?
- Linperlisib in combination with Obinutuzumab and Venetoclax
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2024to 1 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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;
- Mother cell type mantle cell lymphoma (BV-MCL) confirmed by histopathological and immunophenotypic analysis;
- The Eastern Oncology Collaborative Group (ECOG) scored 0-2 on physical fitness status;
- Expected lifespan ≥ 3 months
- There is at least one measurable lesion: the longest diameter (LDi) of lymph node lesions is ≥ 1.5 cm, or the LDi of extralymph node lesions is ≥ 1 cm, or splenomegaly, or bone marrow involvement with or without malignant lymphocytosis;
- Have not received treatment with PI3K inhibitors and BCL-2 inhibitors in the past; Having sufficient bone marrow and organ functions;
Show all 22Show fewer
- Having sufficient bone marrow and organ functions;
- All screening period laboratory tests must be conducted according to the requirements of the plan, and must be conducted within 7 days before enrollment. The values of laboratory tests conducted for screening must meet the following criteria:
- Blood routine examination (no blood transfusion, no use of granulocyte colony-stimulating factor (G-CSF), no medication correction within 14 days prior to screening):
- Hemoglobin (Hb) ≥ 80 g/L;
- Neutrophils (ANC) ≥ 1.0 × 109/L;
- Platelet count (PLT) ≥ 75 × 109/L;
- Biochemical examination:
- TBIL<1.5 × Upper limit of normal range (ULN);
- Glutamate alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN;
- Serum creatinine (Cr) ≤ 1.25 × ULN or endogenous creatinine clearance rate ≥ 60 mL/min (Cockcroft Gault formula);
- Coagulation function (unless the subject is receiving anticoagulant therapy and the coagulation parameters (PT/INR and APTT) are within the expected range of anticoagulant therapy at the time of screening):
- International normalized ratio (INR) ≤ 1.5 × ULN;
- Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN;
- Those who have not participated in clinical trials of other drugs within the 4 weeks prior to enrollment;
- Women with a possibility of pregnancy must undergo a serum pregnancy test within 7 days before the first medication, and the result is negative. They are willing to Intended to use efficient methods of contraception during the trial period and within 1 year after the last administration of the investigational drug. For male subjects whose partners are women of childbearing age, they should undergo surgical sterilization or agree to use high-efficiency contraception methods during the trial period and 1 year after the last administration of the trial drug;
- The subjects voluntarily joined this study, signed an informed consent form, had good compliance, and cooperated with follow-up.
Who cannot join
- Patients who have received any targeted PI3K or BCL treatment before enrollment;
- History of other primary invasive malignant tumors that have not been relieved or have not been relieved for more than 3 years;
- Those with involvement of the central nervous system (meninges or brain parenchyma);
- Individuals who are known to have allergies to any medication in the study;
- Participated in clinical trials of other drugs within 4 weeks prior to the start of the study;
- Pregnant or lactating women;
Show all 24Show fewer
- Individuals with active infections, excluding fever related to tumor B symptoms;
- Concomitant diseases and medical history:
- There are multiple factors that affect oral medication, such as inability to swallow, chronic diarrhea, and intestinal obstruction
- Individuals with a history of psychiatric drug abuse who are unable to quit or have mental disorders;
- Subjects with any severe and/or uncontrolled diseases, including:
- Poor blood pressure control (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg);
- Suffering from ≥ grade 2 myocardial ischemia or myocardial infarction, arrhythmia [including QTc ≥ 450ms (male), QTc ≥ 470ms (female)], and ≥ grade 2 congestive heart failure [NYHA classification];
- Active interstitial pneumonia or other chronic lung diseases leading to severe impairment of lung function, defined as FEV1 and DLCOc<60% of normal predicted values;
- Liver abnormalities;
- Decompensated cirrhosis (Child Pugh liver function rating of B or C)
- Known clinically significant history of liver disease. Including viral hepatitis, known carriers of hepatitis B virus (HBV) must exclude active HBV infection, i.e. HBV DNA positivity (>2500 copies/mL or>500 IU/mL, and above the upper limit of normal values); Known hepatitis C virus infection (HCV) and HCV RNA positivity (>1×103copies/mL). Note: hepatitis B HBsAg positive subjects who meet the inclusion conditions, whether their HBV DNA is measurable or not, need to continue antiviral treatment (nucleoside analogues are recommended) and regularly monitor HBV DNA; For subjects with positive HBcAb but negative HBsAg in hepatitis B, HBV DNA should be monitored regularly and preventive antiviral treatment should be recommended; Hepatitis C patients need to regularly monitor HCV RNA.
- Renal failure requiring hemodialysis or peritoneal dialysis;
- Subjects with uncontrolled pleural effusion, pericardial effusion, or ascites that require repeated drainage;
- Poor control of diabetes (FBG>10 mmol/L);
- Urine routine indicates urine protein ≥++, and it is confirmed that the 24-hour urine protein quantification is greater than 1.0 g;
- Have a history of immunodeficiency, including HIV testing positive, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;
- According to the researcher's judgment, there are accompanying diseases that seriously endanger patient safety or affect patient completion of the study. Unable to understand the nature of the research or disagrees to sign an informed consent form;
- The researcher evaluates other situations that are not suitable for inclusion in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Second Hospital Dalian Medical University
Dalian, Liaoning, 116000
Xiuhua Sun, Doctor, +86 17709873631, 3038668@vip.sina.com
About this study
Official title: A Single-arm, Open-label, National Multi-center Clinical Study of Linperlisib in Combination With Obinutuzumab and Venetoclax in the Treatment of Relapsed and Refractory Blastoid Variant of Mantle Cell Lymphoma (R/R BV-MCL)
This is a single arm, open label, national multicenter clinical study included patients with relapsed and refractory blastoid variant of mantle cell lymphoma (R/R BV-MCL), aiming to evaluate the efficacy of a chemotherapy free triple therapy of PI3K inhibitor (Linperlisib) combined with anti-CD20 monoclonal antibody (Obinutuzumab) and BCL-2 inhibitor (Venetoclax) in R/R BV-MCL patients.
Read the detailed description
This is a single arm, open label, national multicenter clinical study that included 10 cases of relapsed and refractory blastoid variant of mantle cell lymphoma (R/R BV-MCL). The aim was to evaluate the efficacy of a chemotherapy free triple therapy consisting of PI3K inhibitor (Linperlisib) combined with anti-CD20 monoclonal antibody (Obinutuzumab) and BCL-2 inhibitor (Venetoclax) in patients with R/R BV-MCL. It is divided into a combined induction period and a maintenance treatment period. All enrolled patients receive the following combined treatment: combined induction period: Linperlisib: 80 mg, orally (pre - and post meal), once a day; Obinutuzumab: 1000 mg/dose, intravenous infusion, administered on the first day (1st cycle is 1, 8, 15 days); (Up to 6 cycles, administration cycle can be adjusted according to clinical treatment conditions); Venetoclax: increase from 40mg, 100mg, and 200mg to 400mg within 4 weeks, followed by a treatment cycle of 400mg orally once a day; (Starting from the third cycle). Every 28 days, there are a total of 6 cycles. Maintenance treatment period: Linperlisib: 80 mg, oral (both before and after meals), once a day; Venetoclax: 400 mg, oral, once daily. Cycle every 28 days. After 6 cycles of combined treatment, the efficacy is evaluated according to the Lugano2014 standard. If complete remission (CR) or partial remission (PR) is achieved, maintenance treatment with a combination of 80 mg of linprixate and 400 mg of vinclair is administered every 28 days until disease progression, intolerable toxicity, or other reasons lead to discontinuation. If it is stable disease (SD) and progressive disease (PD), patients will be excluded from the group. The main research endpoint is Objective Response Rate (ORR). Secondary study endpoints include progression free survival (PFS); Overall survival (OS), duration of response (DOR), and safety: incidence and severity of adverse events (AE) and severe adverse events (SAE). Safety: incidence and severity of adverse events (AE) and severe adverse events (SAE).
- Conditions
- Mantle Cell Lymphoma
- Being tested
- Linperlisib in combination with Obinutuzumab and Venetoclax
- Keywords
- Linperlisib, Venetoclax, Obinutuzumab
- Medical subject headings
- Lymphoma, Mantle-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Linperlisib in combination with Obinutuzumab and VenetoclaxDrug
Also called Treatment group
Combined induction period: Linprixate: 80 mg, oral (pre - and post meal), once a day; Otuzumab: 1000 mg/dose, intravenous infusion, administered on the first day (1st cycle is 1, 8, 15 days); (Up to 6 cycles, administration cycle can be adjusted according to clinical treatment conditions); Vineclavone: increase from 40mg, 100mg, and 200mg to 400mg within 4 weeks, followed by a treatment cycle of 400mg orally once a day; (Starting from the third cycle), one cycle every 28 days, for a total of 6 cycles。 Maintenance treatment period: Linprixate: 80 mg, oral (both before and after meals), once a day; Vinecala: 400 mg, oral, once daily; Cycle every 28 days.
| Study group | Role | What they receive |
|---|---|---|
| cohort 1 | Experimental | Patients with relapsed refractory lymphoblastic mantle cell lymphoma who have not previously received treatment with PI3K inhibitors and BCL-2 inhibitors Receives: Drug: Linperlisib in combination with Obinutuzumab and Venetoclax |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR) according to the RECIST 1.1
The ORR rate of patients with Linperlisib in combination with Obinutuzumab and Venetoclax for relapsed and refractory blastoid variant of mantle cell lymphom
Measured: At the end of Cycle 6 (each cycle is 28 days)
Secondary outcomes (4)
Progression-free survival (PFS)
The time from the start of clinical trials to the occurrence (in any aspect) of tumor progression or death due to any reason
Measured: From date of enrollment until the date of first documented progression and loss of follow-up or date of death from any cause, whichever came first, assessed up to 24 months
Overall survival (OS)
The time from the start of tumor treatment to (for any reason) death.
Measured: From date of enrollment until the date of first date of death from any cause, expected evaluation period of up to 48 months
Duration of Overall Response (DOR)
The time from the first judgment of complete remission (CR) or partial remission (PR) to the discovery of disease progression (PD).
Measured: From date of the time from the first assessment of the tumor as CR or PR to the first assessment as PD (Progressive Disease) or death from any cause,assessed up to 24 months
Adverse event (AE)
Refers to adverse medical events that occur in the clinical trial process of the subject
Measured: Record any adverse events starting from the first medication use until the end of the safety follow-up period. The evaluation period shall not exceed 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start1 May 2024 (estimated)
- Primary completion1 May 2025 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mantle 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dalian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiuhua Sun, Dalian Medical University
- Investigators
- Xiuhua Sun, Doctor, Study director, Dalian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06324994
- Sponsor's protocol ID
- YY-20394-BV-MCL
- Status last verified
- Mar 2024
- First submitted
- 9 Mar 2024
- Last updated
- 22 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Open-label, National Multi-center Clinical Study of Linperlisib in Combination With Obinutuzumab and Venetoclax in the Treatment of Relapsed and Refractory Blastoid Variant of Mantle Cell Lymphoma (R/R BV-MCL)
- ClinicalTrials.gov ID
- NCT06324994
- Acronym / sponsor ID
- YY-20394-BV-MCL
- Conditions
- Mantle Cell Lymphoma
- Keywords
- Linperlisib, Venetoclax, Obinutuzumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Dalian Medical UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 22 Mar 2024 (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 single arm, open label, national multicenter clinical study included patients with relapsed and refractory blastoid variant of mantle cell lymphoma (R/R BV-MCL), aiming to evaluate the efficacy of a chemotherapy free triple therapy of PI3K inhibitor (Linperlisib) combined with anti-CD20 monoclonal antibody (Obinutuzumab) and BCL-2 inhibitor (Venetoclax) in R/R BV-MCL patients.
Detailed description
This is a single arm, open label, national multicenter clinical study that included 10 cases of relapsed and refractory blastoid variant of mantle cell lymphoma (R/R BV-MCL). The aim was to evaluate the efficacy of a chemotherapy free triple therapy consisting of PI3K inhibitor (Linperlisib) combined with anti-CD20 monoclonal antibody (Obinutuzumab) and BCL-2 inhibitor (Venetoclax) in patients with R/R BV-MCL. It is divided into a combined induction period and a maintenance treatment period. All enrolled patients receive the following combined treatment: combined induction period: Linperlisib: 80 mg, orally (pre - and post meal), once a day; Obinutuzumab: 1000 mg/dose, intravenous infusion, administered on the first day (1st cycle is 1, 8, 15 days); (Up to 6 cycles, administration cycle can be adjusted according to clinical treatment conditions); Venetoclax: increase from 40mg, 100mg, and 200mg to 400mg within 4 weeks, followed by a treatment cycle of 400mg orally once a day; (Starting from the third cycle). Every 28 days, there are a total of 6 cycles. Maintenance treatment period: Linperlisib: 80 mg, oral (both before and after meals), once a day; Venetoclax: 400 mg, oral, once daily. Cycle every 28 days. After 6 cycles of combined treatment, the efficacy is evaluated according to the Lugano2014 standard. If complete remission (CR) or partial remission (PR) is achieved, maintenance treatment with a combination of 80 mg of linprixate and 400 mg of vinclair is administered every 28 days until disease progression, intolerable toxicity, or other reasons lead to discontinuation. If it is stable disease (SD) and progressive disease (PD), patients will be excluded from the group. The main research endpoint is Objective Response Rate (ORR). Secondary study endpoints include progression free survival (PFS); Overall survival (OS), duration of response (DOR), and safety: incidence and severity of adverse events (AE) and severe adverse events (SAE). Safety: incidence and severity of adverse events (AE) and severe adverse events (SAE).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cohort 1 | Experimental | Drug: Linperlisib in combination with Obinutuzumab and VenetoclaxPatients with relapsed refractory lymphoblastic mantle cell lymphoma who have not previously received treatment with PI3K inhibitors and BCL-2 inhibitors |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Age ≥ 18 years old;
- Mother cell type mantle cell lymphoma (BV-MCL) confirmed by histopathological and immunophenotypic analysis;
- The Eastern Oncology Collaborative Group (ECOG) scored 0-2 on physical fitness status;
- Expected lifespan ≥ 3 months
- There is at least one measurable lesion: the longest diameter (LDi) of lymph node lesions is ≥ 1.5 cm, or the LDi of extralymph node lesions is ≥ 1 cm, or splenomegaly, or bone marrow involvement with or without malignant lymphocytosis;
Key exclusion criteria (24 listed)
- Patients who have received any targeted PI3K or BCL treatment before enrollment;
- History of other primary invasive malignant tumors that have not been relieved or have not been relieved for more than 3 years;
- Those with involvement of the central nervous system (meninges or brain parenchyma);
- Individuals who are known to have allergies to any medication in the study;
- Participated in clinical trials of other drugs within 4 weeks prior to the start of the study;
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 |
|---|---|---|
| Linperlisib in combination with Obinutuzumab and VenetoclaxAlso: Treatment groupCombined induction period: Linprixate: 80 mg, oral (pre - and post meal), once a day; Otuzumab: 1000 mg/dose, intravenous infusion, administered on the first day (1st cycle is 1, 8, 15 days); (Up to 6 cycles, administration cycle can be adjusted according to clinical treatment conditions); Vineclavone: increase from 40mg, 100mg, and 200mg to 400mg within 4 weeks, followed by a treatment cycle of 400mg orally once a day; (Starting from the third cycle), one cycle every 28 days, for a total of 6 cycles。 Maintenance treatment period: Linprixate: 80 mg, oral (both before and after meals), once a day; Vinecala: 400 mg, oral, once daily; Cycle every 28 days. | Drug | cohort 1 |
Primary outcome
Objective Response Rate (ORR) according to the RECIST 1.1
Time frame: At the end of Cycle 6 (each cycle is 28 days)
The ORR rate of patients with Linperlisib in combination with Obinutuzumab and Venetoclax for relapsed and refractory blastoid variant of mantle cell lymphom
4 secondary outcomes
Progression-free survival (PFS)
Time frame: From date of enrollment until the date of first documented progression and loss of follow-up or date of death from any cause, whichever came first, assessed up to 24 months
Overall survival (OS)
Time frame: From date of enrollment until the date of first date of death from any cause, expected evaluation period of up to 48 months
Duration of Overall Response (DOR)
Time frame: From date of the time from the first assessment of the tumor as CR or PR to the first assessment as PD (Progressive Disease) or death from any cause,assessed up to 24 months
Adverse event (AE)
Time frame: Record any adverse events starting from the first medication use until the end of the safety follow-up period. The evaluation period shall not exceed 24 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Mantle Cell Lymphoma
Not yet recruitingPhase 1
Testing the Addition of an Anti-Cancer Drug, Glofitamab, to the Usual Chemotherapy Treatment (Alternating R-CHOP/R-DHAP) for Previously Untreated Mantle Cell Lymphoma
Ann Arbor Stage II Mantle Cell Lymphoma, Ann Arbor Stage III Mantle Cell Lymphoma
RecruitingPhase 3
A Study to Evaluate Glofitamab as a Single Agent vs. Investigator's Choice in Participants With Relapsed/Refractory Mantle Cell Lymphoma
Lymphoma
RecruitingPhase 1
A Study of LY4152199 in Participants With Previously Treated B-cell Malignancies (BAF_FRontier-1 )
Lymphoma, Non-Hodgkin, B-cell Lymphoma
RecruitingPhase 2
Auto Stem Cell Transplant for Lymphoma Patients
Non-Hodgkin Lymphoma, Hodgkin Lymphoma
Active, not recruitingPhase 1
Study to Evaluate Adverse Events, Change in Disease Activity, and How Oral ABBV-101 Moves Through the Body in Adult Participants With B-Cell Malignancies
Hematologic Cancer
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.
Xiuhua Sun, Doctor study director
Dalian Medical University
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 Linperlisib in combination with Obinutuzumab and Venetoclax in people with Mantle Cell Lymphoma, run by Dalian Medical University 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 22 inclusion and 24 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: opening soon, as of the sponsor's last update on 22 Mar 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiuhua Sun, Doctor (+86 17709873631, 3038668@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) according to the RECIST 1.1 (time frame: At the end of Cycle 6 (each cycle is 28 days)). 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 22 Mar 2024.