LymphomaPhase 1/2MZL-001NCT06592170
Linperlisib Combination With Obinutuzumab Frontline Treatment of Marginal Zone Lymphoma Patients (MZL)
A Phase 1/2 study testing Linperlisib combination with obinutuzumab in people with Lymphoma, run by The First Hospital of Jilin University at 1 site in China.
Trial summary
This is a single arm, open label, national multicenter clinical study included patients with marginal zone lymphoma patients (MZL) , aim is to evaluate the efficacy and safety of first-line treatment with Linperlisib combined with obinutuzumab in patients with marginal zone lymphoma (MZL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma
- What is being tested?
- Linperlisib combination with obinutuzumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteChina
- Study dates
- 13 Aug 2024to 13 Aug 2027
- Phase
- Phase 1/2
- 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
- 1. Age ≥ 18 years old, both male and female are acceptable; 2. Newly diagnosed marginal zone lymphoma confirmed by histopathology. Including extranodal MZL, intranodal MZL, and splenic MZL; 3. There is at least one measurable lesion: the longest diameter (LDi) of a lymph node lesion is greater than 1.5 cm or the LDi of an extra lymph node lesion is greater than 1 cm (according to the 2014 Lugano classification); 4. The physical status score of the Eastern Cooperative Oncology Group (ECOG) is ≤ 2; 5. Expected lifespan ≥ 12 weeks; 6. Have not received any previous anti-tumor treatment; 7. Possess sufficient bone marrow and organ functions; 8. All screening laboratory tests must be conducted according to the protocol requirements, and must be conducted within 7 days prior to enrollment. The values of laboratory tests conducted for screening must meet the following standards:
- Blood routine examination (no blood transfusion within 14 days before screening, no use of granulocyte colony-stimulating factor (G-CSF), no medication correction):
- Hemoglobin (Hb) ≥ 90 g/L;
- Neutrophil count (ANC) ≥ 1.5 × 10*9/L;
- Platelets (PLT) ≥ 100 × 10*9/L;
- Biochemical examination:
Show all 12Show fewer
- TBIL<1.5 x upper limit of normal range (ULN);
- Glutamate alanine aminotransferase (ALT) and Glutamate 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:
- International Normalized Ratio (INR) ≤ 1.5 × ULN;
- Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN; 9. Women who have the possibility of pregnancy must undergo a serum pregnancy test within 7 days before the first use of the test drug, and the result must be negative. They must also be willing to use effective contraception methods during the trial period and within 1 year after the last administration of the test drug. For male participants whose partners are women of childbearing age, surgical sterilization should be performed, or they should agree to use efficient contraception methods during the trial period and one year after the last administration of the trial drug; 10. The subjects voluntarily joined this study, signed an informed consent form, had good compliance, and cooperated with follow-up
Who cannot join
- 1. Patients who have received any targeted PI3K therapy before enrollment; 2. History of other primary invasive malignant tumors that have not been relieved or have not been relieved for more than 3 years; 3. Patients with involvement of the central nervous system (meninges or brain parenchyma); 4. Individuals who are known to have allergies to any of the drugs in the study; 5. Participated in clinical trials of other drugs within 4 weeks prior to the start of the study; 6. Pregnant or lactating women; 7. Individuals with active infections, except for those with tumor related B symptoms and fever; 8. Combined diseases and medical history:
- There are multiple factors that can affect oral medication, such as inability to swallow, chronic diarrhea, and intestinal obstruction;
- Individuals with a history of abuse of psychotropic drugs who are unable to quit or have mental disorders;
- Subjects with any severe and/or uncontrolled illnesses, including:
- Poor blood pressure control (systolic blood pressure ≥ 150mmHg 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 [New York Heart Association (NYHA) classification];
Show all 14Show fewer
- 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; History of interstitial pneumonia caused by COVID-19.
- Liver abnormalities:
- Decompensated cirrhosis (Child Pugh liver function rating B or C)
- Known history of liver disease with clinical significance. Including viral hepatitis, known carriers of hepatitis B virus (HBV) must exclude active HBV infection, i.e. HBV DNA positive (>2500 copies/mL or >500IU/mL, and greater than the upper limit of normal); Known to be infected with hepatitis C virus (HCV) and HCV RNA positive (>1 × 103 copies/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; HCV RNA should be regularly monitored in subjects with hepatitis C.
- Patients with 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>10mmol/L);
- Urine routine shows urinary protein ≥++and confirms 24-hour urinary protein quantification>1.0g; 9. History of immunodeficiency, including HIV testing positive, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; 10.According to the researchers assessment, there are accompanying diseases that pose a serious threat to patient safety or affect the completion of 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.
Ou Bai Ou Bai, MD/PHD, The First Hospital of Jilin University, MD/PHD contact
China1 site, 1 recruiting
- Recruiting
The First Hospital of Jilin University
Changchun, Jilin, 130000
About this study
Official title: A Single Arm, Open Center, Multicenter Clinical Study of Frontline Treatment of Marginal Zone Lymphoma Patients (MZL) With Linperlisib Combined With Obinutuzumab
This is a single arm, open label, national multicenter clinical study included patients with marginal zone lymphoma patients (MZL) , aim is to evaluate the efficacy and safety of first-line treatment with Linperlisib combined with obinutuzumab in patients with marginal zone lymphoma (MZL).
Read the detailed description
This study is a single arm, open label, multicenter Phase Ib/II study aimed at evaluating the safety and efficacy of first-line treatment of patients with marginal zone lymphoma with combination therapy of Linperlisib and obinutuzumab. The study is divided into Phase Ib safety introduction stage, and Phase II is recommended; As well as the Phase II expansion phase, the research design is shown in the following figure. Phase Ib is the safety introduction period, with the main purpose of determining the recommended Phase II effective dose (RP2D) based on dose limiting toxicity (DLT). Six subjects are planned to be enrolled to observe the safety of one cycle of combination therapy with Linperlisib (80 mg, once daily). If\<2 cases of DLT occur, the RP2D of Linperlisib will be 80 mg, once daily; If there are ≥ 2 cases of DLT, RP2D is 60 mg once daily. Phase II is the expansion phase, which involves induction therapy with two cycles of Linperlisib RP2D combined with obinutuzumab. All patients who achieve complete remission (CR) or partial remission (PR) after induction therapy receive induction therapy with a dose of Linperlisib, which is maintained every 28 days for one cycle until disease progression or other reasons lead to discontinuation. During the maintenance phase, the use of Linperlisib should not exceed 24 months. If the disease is stable (SD) or (PD), the patient will be removed from the group. If a patient fails to achieve CP or PR after two cycles of induction therapy, the researcher will determine whether to continue induction therapy. Induction therapy can last up to six cycles.The aim is to evaluate the efficacy and safety of first-line treatment with Linperlisib combined with obinutuzumab in patients with marginal zone lymphoma (MZL).
- Conditions
- Lymphoma
- Being tested
- Linperlisib combination with obinutuzumab
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Linperlisib combination with obinutuzumabDrug
Safe import period: Linperlisib: 80 mg, oral (pre - and post meal), QD; obinutuzumab: 1000 mg, intravenous infusion, administered on the first day (1st cycle on days 1, 8, and 15); Every 28 days, there is one cycle in total.
Extended treatment period: Combination induction: Linperlisib: RP2D, oral (pre - and post meal), QD; obinutuzumab: 1000 mg/time, intravenous infusion, administered on the first day (1st cycle on days 1, 8, and 15); Every 28 days, there are 2 cycles in total. Afterwards, single drug maintenance: Linperlisib: RP2D, oral (before and after meals), QD; every 28 days per cycle.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Safe import period: Linperlisib: 80 mg, oral (pre - and post meal), QD; obinutuzumab: 1000 mg, intravenous infusion, administered on the first day (1st cycle on days 1, 8, and 15); Every 28 days, there is one cycle in total.
Extended treatment period: Combination induction: Linperlisib: RP2D, oral (pre - and post meal), QD; obinutuzumab: 1000 mg/time, intravenous infusion, administered on the first day (1st cycle on days 1, 8, and 15); Every 28 days, there are 2 cycles in total. Afterwards, single drug maintenance: Linperlisib: RP2D, oral (before and after meals), QD; every 28 days per cycle. Receives: Drug: Linperlisib combination with obinutuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response（CR） according to the RECIST 1.1
The CR rate of patients with Linperlisib in combination with Obinutuzumab for marginal zone lymphoma
Measured: 6 months from the start of linperlisib treatment
Secondary outcomes (5)
Objective Response Rate (ORR) according to the RECIST 1.1
The ORR rate of patients with Linperlisib in combination with Obinutuzumab for marginal zone lymphoma
Measured: 6 months from the start of linperlisib treatment
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: Within 2 year from the start of Linperlisib treatment，the time from the first judgment of complete remission (CR) or partial remission (PR) to the discovery of disease progression (PD)
Adverse event
Refers to adverse medical events that occur in the clinical trial process of the subject
Measured: Within 2 year from the start of Linperlisib treatment
Disease control rate（DCR）
Proportion of patients with remission (PR+CR) and stable disease (SD) within 2 years after Linperlisib treatment.
Measured: Within 2 year from the start of Linperlisib treatment
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: Within 2 years of initiation of Linperlisib treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start13 Aug 2024
- Primary completion13 Aug 2025 (estimated)
- Study completion13 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by The First Hospital of Jilin UniversityThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ou Bai, MD/PHD, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06592170
- Sponsor's protocol ID
- YY-20394-MZL-001
- Acronym
- MZL-001
- Status last verified
- Sep 2024
- First submitted
- 7 Sep 2024
- Last updated
- 19 Sep 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm, Open Center, Multicenter Clinical Study of Frontline Treatment of Marginal Zone Lymphoma Patients (MZL) With Linperlisib Combined With Obinutuzumab
- ClinicalTrials.gov ID
- NCT06592170
- Acronym / sponsor ID
- MZL-001 / YY-20394-MZL-001
- Conditions
- Lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 13 Aug 2024 (actual)
- Primary completion
- 13 Aug 2025 (estimated)
- Study completion
- 13 Aug 2027 (estimated)
- First posted
- 19 Sep 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 marginal zone lymphoma patients (MZL) , aim is to evaluate the efficacy and safety of first-line treatment with Linperlisib combined with obinutuzumab in patients with marginal zone lymphoma (MZL).
Detailed description
This study is a single arm, open label, multicenter Phase Ib/II study aimed at evaluating the safety and efficacy of first-line treatment of patients with marginal zone lymphoma with combination therapy of Linperlisib and obinutuzumab. The study is divided into Phase Ib safety introduction stage, and Phase II is recommended; As well as the Phase II expansion phase, the research design is shown in the following figure. Phase Ib is the safety introduction period, with the main purpose of determining the recommended Phase II effective dose (RP2D) based on dose limiting toxicity (DLT). Six subjects are planned to be enrolled to observe the safety of one cycle of combination therapy with Linperlisib (80 mg, once daily). If\<2 cases of DLT occur, the RP2D of Linperlisib will be 80 mg, once daily; If there are ≥ 2 cases of DLT, RP2D is 60 mg once daily. Phase II is the expansion phase, which involves induction therapy with two cycles of Linperlisib RP2D combined with obinutuzumab. All patients who achieve complete remission (CR) or partial remission (PR) after induction therapy receive induction therapy with a dose of Linperlisib, which is maintained every 28 days for one cycle until disease progression or other reasons lead to discontinuation. During the maintenance phase, the use of Linperlisib should not exceed 24 months. If the disease is stable (SD) or (PD), the patient will be removed from the group. If a patient fails to achieve CP or PR after two cycles of induction therapy, the researcher will determine whether to continue induction therapy. Induction therapy can last up to six cycles.The aim is to evaluate the efficacy and safety of first-line treatment with Linperlisib combined with obinutuzumab in patients with marginal zone lymphoma (MZL).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Linperlisib combination with obinutuzumabSafe import period: Linperlisib: 80 mg, oral (pre - and post meal), QD; obinutuzumab: 1000 mg, intravenous infusion, administered on the first day (1st cycle on days 1, 8, and 15); Every 28 days, there is one cycle in total. Extended treatment period: Combination induction: Linperlisib: RP2D, oral (pre - and post meal), QD; obinutuzumab: 1000 mg/time, intravenous infusion, administered on the first day (1st cycle on days 1, 8, and 15); Every 28 days, there are 2 cycles in total. Afterwards, single drug maintenance: Linperlisib: RP2D, oral (before and after meals), QD; every 28 days per cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 1. Age ≥ 18 years old, both male and female are acceptable; 2. Newly diagnosed marginal zone lymphoma confirmed by histopathology. Including extranodal MZL, intranodal MZL, and splenic MZL; 3. There is at least one measurable lesion: the longest diameter (LDi) of a lymph node lesion is greater than 1.5 cm or the LDi of an extra lymph node lesion is greater than 1 cm (according to the 2014 Lugano classification); 4. The physical status score of the Eastern Cooperative Oncology Group (ECOG) is ≤ 2; 5. Expected lifespan ≥ 12 weeks; 6. Have not received any previous anti-tumor treatment; 7. Possess sufficient bone marrow and organ functions; 8. All screening laboratory tests must be conducted according to the protocol requirements, and must be conducted within 7 days prior to enrollment. The values of laboratory tests conducted for screening must meet the following standards:
- Blood routine examination (no blood transfusion within 14 days before screening, no use of granulocyte colony-stimulating factor (G-CSF), no medication correction):
- Hemoglobin (Hb) ≥ 90 g/L;
- Neutrophil count (ANC) ≥ 1.5 × 10*9/L;
- Platelets (PLT) ≥ 100 × 10*9/L;
Key exclusion criteria (14 listed)
- 1. Patients who have received any targeted PI3K therapy before enrollment; 2. History of other primary invasive malignant tumors that have not been relieved or have not been relieved for more than 3 years; 3. Patients with involvement of the central nervous system (meninges or brain parenchyma); 4. Individuals who are known to have allergies to any of the drugs in the study; 5. Participated in clinical trials of other drugs within 4 weeks prior to the start of the study; 6. Pregnant or lactating women; 7. Individuals with active infections, except for those with tumor related B symptoms and fever; 8. Combined diseases and medical history:
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 combination with obinutuzumabSafe import period: Linperlisib: 80 mg, oral (pre - and post meal), QD; obinutuzumab: 1000 mg, intravenous infusion, administered on the first day (1st cycle on days 1, 8, and 15); Every 28 days, there is one cycle in total. Extended treatment period: Combination induction: Linperlisib: RP2D, oral (pre - and post meal), QD; obinutuzumab: 1000 mg/time, intravenous infusion, administered on the first day (1st cycle on days 1, 8, and 15); Every 28 days, there are 2 cycles in total. Afterwards, single drug maintenance: Linperlisib: RP2D, oral (before and after meals), QD; every 28 days per cycle. | Drug | Experimental group |
Primary outcome
Complete response（CR） according to the RECIST 1.1
Time frame: 6 months from the start of linperlisib treatment
The CR rate of patients with Linperlisib in combination with Obinutuzumab for marginal zone lymphoma
5 secondary outcomes
Objective Response Rate (ORR) according to the RECIST 1.1
Time frame: 6 months from the start of linperlisib treatment
Duration of Overall Response (DOR）
Time frame: Within 2 year from the start of Linperlisib treatment，the time from the first judgment of complete remission (CR) or partial remission (PR) to the discovery of disease progression (PD)
Adverse event
Time frame: Within 2 year from the start of Linperlisib treatment
Disease control rate（DCR）
Time frame: Within 2 year from the start of Linperlisib treatment
Progression-free survival（PFS）
Time frame: Within 2 years of initiation of Linperlisib treatment
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 19 Sep 2024.
- Individual participant dataSharing planned: No
Related trials for Lymphoma
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
RecruitingPhase 2
Ibrutinib Combination Therapy in Transplant Ineligible Individuals With Newly Diagnosed Primary CNS Lymphoma
Non-hodgkin Lymphoma
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
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
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
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.
Ou Bai Ou Bai, MD/PHD, The First Hospital of Jilin University, MD/PHD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Linperlisib combination with obinutuzumab in people with Lymphoma, run by The First Hospital of Jilin 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 12 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 19 Sep 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 combined 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.
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 Ou Bai Ou Bai, MD/PHD, The First Hospital of Jilin University, MD/PHD (13039046656, oubai16@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete response（CR） according to the RECIST 1.1 (time frame: 6 months from the start of linperlisib treatment). 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 19 Sep 2024.