FLPhase 2NCT06474481
Zanubrutinib and G-CHOP in Untreated Intermediate-high Risk Follicular Lymphoma
A Phase 2 study testing Zanubrutinib, Obinutuzumab and Prednisone in people with FL, run by Tianjin Medical University Cancer Institute and Hospital.
Trial summary
:This is a an open-label, single-arm study to evaluate the efficacy and safety of zanubrutinib and G-CHOP in untreated Intermediate-high risk Follicular Lymphoma patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- FL
- What is being tested?
- Zanubrutinib, Obinutuzumab and Prednisone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jul 2024to Dec 2029
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed CD20 positive (+) follicular lymphoma, grade 1, 2, or 3a
- Have had no prior systemic treatment for lymphoma
- Meeting Groupe d'Etude des Lymphomes Folliculaires (GELF) criteria for initiation of treatment
- 18-75 years old.
- ECOG Performance Status of 0-2 within 10 days prior to registration.
- Stage II, III, or IV by Ann Arbor staging system.
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- defined as Intermediate-high risk by the follicular lymphoma international prognostic index (FLIPI) 1 or FLIPI 2.
- Demonstrate adequate organ function as defined below; all screening labs to be obtained within 28 days prior to registration.
- Hematological: WBC≥3.5×109/L, Platelets ≥ 75×109/L,Absolute Neutrophil Count (ANC) ≥ 1.0×109/L，Hemoglobin (Hgb) ≥ 80 g/L
- Renal:Calculated creatinine clearance ≥ 50 mL/min
- Hepatic:Bilirubin ≤ 1.5 × upper limit of normal (ULN), AST/ALT ≤ 2.5×ULN
- Females of childbearing potential must be willing to abstain from vaginal intercourse or use an effective method(s) of contraception from the time of informed consent, during the study and for 6 months after the last dose of study drug(s). Males able to father a child must be willing to abstain from vaginal intercourse or to use an effective method(s) of contraception from initiation of treatment, during the study and for 3 months after the last dose of study drug(s). See the protocol.
- Life expectancy ≥6 months
- Sign (or their legally-acceptable representatives must sign) an informed consent document indicating that they understand the purpose of and procedures required for the study, including biomarkers, and are willing to participate in the study
Who cannot join
- Known active central nervous system lymphoma or leptomeningeal disease
- Evidence of diffuse large B-cell transformation
- Grade 3b FL
- Concurrent malignancy or malignancy within the last 3 years (except for ductal breast cancer in situ, non-melanoma skin cancer, prostate cancer not requiring treatment, and cervical carcinoma in situ) whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen are not eligible for this trial
- Known history of human immunodeficiency virus (HIV), or active hepatitis C Virus, or active hepatitis B Virus infection, or any uncontrolled active significant infection, including suspected or confirmed John Cunningham (JC) virus infection
- Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any class 3 (moderate) or class 4 (severe) cardiac disease as defined by the New York Heart Association functional classification. Or left ventricular ejection fraction <50%;
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- Neuropathy ≥grade 2
- Known history of human immunodeficiency virus (HIV), or active hepatitis C Virus, or active hepatitis B Virus infection, or any uncontrolled active significant infection
- Known pneumonia associated with idiopathic pulmonary fibrosis, machine (for example, occlusive bronchiolitis), history of drug induced pneumonia, or screening during the chest computed tomography (CT) showed active pneumonia
- Have serious neurological or psychiatric history, can't normal study, including dementia, epilepsy, severe depression and mania
- Patients who were deemed by the investigator to be ineligible for enrollment
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Study of the Zanubrutinib With G-CHOP Regimens in the Frontline Treatment of Intermediate-high Risk Follicular Lymphoma
:This is a an open-label, single-arm study to evaluate the efficacy and safety of zanubrutinib and G-CHOP in untreated Intermediate-high risk Follicular Lymphoma patients.
- Conditions
- FL
- Being tested
- Zanubrutinib, Obinutuzumab, Prednisone, Cyclophosphamide, Vincristine
- Keywords
- Zanubrutinib, Intermediate-high risk Follicular Lymphoma, G-CHOP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZanubrutinibDrug
Zanubrutinib, 160mg PO BID.on days 1-28 Induction treatment: 4-6cycles ; Maintenance: 1 year;
ObinutuzumabDrug
Induction treatment: Obinutuzumab (G), 1000mg, IV, D1/8/15 (C1), D1 (C2-4/6); for 4-6 cycles, 1 cycle = 28 days Maintenance: Obinutuzumab (G), 1000mg, IV, every 2 months for 1 year;
PrednisoneDrug
Prednisone (P), 100 mg, PO, D2-6；for 4-6 cycles for CHOP treatment , 1 cycle = 28 days
CyclophosphamideDrug
Cyclophosphamide (C), 750 mg/m2, IV, D2; for 4-6 cycles for CHOP treatment , 1 cycle = 28 days
VincristineDrug
Vincristine (O), 1.4 mg/m2 (maximum 2 mg), IV, D2; for 4-6 cycles for CHOP treatment , 1 cycle = 28 days
DoxorubicinDrug
Doxorubicin (H), 50 mg/m2, IV, D2; for 4-6 cycles for CHOP treatment ，1 cycle = 28 days
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | Induction: Zanubrutinib and G-CHOP 4-6cycles
Maintenance: Zanubrutinib and Obinutuzumab 1 year Receives: Drug: Zanubrutinib; Drug: Obinutuzumab; Drug: Prednisone; Drug: Cyclophosphamide; Drug: Vincristine; Drug: Doxorubicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
CR (complete response) rate after induction (4 or 6 Cycles) by investigator (INV)
Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria
Measured: From enrollment to the end of treatment at cycle 4 or 6 (each cycle is 28 days)
Secondary outcomes (3)
Objective Response rate after induction by investigator (INV)
ORR is defined as the proportion of patients achieving complete response (CR) or partial response (PR), as determined by INV according to 2014 Lugano criteria
Measured: From enrollment to the end of end of treatment at cycle 4 or 6 (each cycle is 28 days)
Overall survival (OS)
Overall survival (OS) is defined as the duration from the date of initiation of the first cycle of treatment to the date of death because of any cause
Measured: From the date of cycle 1, day 1 to the date of death regardless of cause, assessed up to 3 years
Progression free survival (PFS)
-PFS defined as time from the date of enrollment to the date of first confirmed disease progression or death due to any cause, whichever occurs first, as determined by INV
Measured: From the date of cycle 1, day 1 to the date of death regardless of cause, assessed up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study startJul 2024 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FLStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe 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
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06474481
- Sponsor's protocol ID
- TN-FL001
- Status last verified
- Jun 2024
- First submitted
- 12 Jun 2024
- Last updated
- 25 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Zanubrutinib With G-CHOP Regimens in the Frontline Treatment of Intermediate-high Risk Follicular Lymphoma
- ClinicalTrials.gov ID
- NCT06474481
- Acronym / sponsor ID
- TN-FL001
- Conditions
- FL
- Keywords
- Zanubrutinib, Intermediate-high risk Follicular Lymphoma, G-CHOP
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- Jul 2024 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 25 Jun 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 an open-label, single-arm study to evaluate the efficacy and safety of zanubrutinib and G-CHOP in untreated Intermediate-high risk Follicular Lymphoma patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Drug: Zanubrutinib, Drug: Obinutuzumab, Drug: Prednisone, Drug: Cyclophosphamide, Drug: Vincristine, Drug: DoxorubicinInduction: Zanubrutinib and G-CHOP 4-6cycles Maintenance: Zanubrutinib and Obinutuzumab 1 year |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Histologically confirmed CD20 positive (+) follicular lymphoma, grade 1, 2, or 3a
- Have had no prior systemic treatment for lymphoma
- Meeting Groupe d'Etude des Lymphomes Folliculaires (GELF) criteria for initiation of treatment
- 18-75 years old.
- ECOG Performance Status of 0-2 within 10 days prior to registration.
Key exclusion criteria (11 listed)
- Known active central nervous system lymphoma or leptomeningeal disease
- Evidence of diffuse large B-cell transformation
- Grade 3b FL
- Concurrent malignancy or malignancy within the last 3 years (except for ductal breast cancer in situ, non-melanoma skin cancer, prostate cancer not requiring treatment, and cervical carcinoma in situ) whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen are not eligible for this trial
- Known history of human immunodeficiency virus (HIV), or active hepatitis C Virus, or active hepatitis B Virus infection, or any uncontrolled active significant infection, including suspected or confirmed John Cunningham (JC) virus 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 |
|---|---|---|
| ZanubrutinibZanubrutinib, 160mg PO BID.on days 1-28 Induction treatment: 4-6cycles ; Maintenance: 1 year; | Drug | Treatment arm |
| ObinutuzumabInduction treatment: Obinutuzumab (G), 1000mg, IV, D1/8/15 (C1), D1 (C2-4/6); for 4-6 cycles, 1 cycle = 28 days Maintenance: Obinutuzumab (G), 1000mg, IV, every 2 months for 1 year; | Drug | Treatment arm |
| PrednisonePrednisone (P), 100 mg, PO, D2-6；for 4-6 cycles for CHOP treatment , 1 cycle = 28 days | Drug | Treatment arm |
| CyclophosphamideCyclophosphamide (C), 750 mg/m2, IV, D2; for 4-6 cycles for CHOP treatment , 1 cycle = 28 days | Drug | Treatment arm |
| VincristineVincristine (O), 1.4 mg/m2 (maximum 2 mg), IV, D2; for 4-6 cycles for CHOP treatment , 1 cycle = 28 days | Drug | Treatment arm |
| DoxorubicinDoxorubicin (H), 50 mg/m2, IV, D2; for 4-6 cycles for CHOP treatment ，1 cycle = 28 days | Drug | Treatment arm |
Primary outcome
CR (complete response) rate after induction (4 or 6 Cycles) by investigator (INV)
Time frame: From enrollment to the end of treatment at cycle 4 or 6 (each cycle is 28 days)
Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria
3 secondary outcomes
Objective Response rate after induction by investigator (INV)
Time frame: From enrollment to the end of end of treatment at cycle 4 or 6 (each cycle is 28 days)
Overall survival (OS)
Time frame: From the date of cycle 1, day 1 to the date of death regardless of cause, assessed up to 3 years
Progression free survival (PFS)
Time frame: From the date of cycle 1, day 1 to the date of death regardless of cause, assessed up to 3 years
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 25 Jun 2024.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Zanubrutinib, Obinutuzumab and Prednisone in people with FL, run by Tianjin Medical University Cancer Institute and Hospital.
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 14 inclusion and 11 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 25 Jun 2024. 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 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 Huilai Zhang, MD,PhD (0086-22-23359337, info@tjmuch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CR (complete response) rate after induction (4 or 6 Cycles) by investigator (INV) (time frame: From enrollment to the end of treatment at cycle 4 or 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 25 Jun 2024.