BTK InhibitorsPhase 2NCT06918015
Zanubrutinib Plus GCVP (Obinutuzumab, Cyclophosphamide, Vindesine, Prednisolone) in Previously Untreated Follicular Lymphoma
A Phase 2 study testing ZGCVP in people with BTK Inhibitors and Follicular Lymphoma, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
Previously untreated patients with follicular lymphoma are treated with the ZGCVP regimen (zanubrutinib, obinutuzumab, cyclophosphamide, vindesine, prednisolone) for 6 cycles. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- BTK Inhibitors, Follicular Lymphoma, Immunochemotherapy
- What is being tested?
- ZGCVP
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2025to 1 May 2030
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participate in the clinical study voluntarily, fully understand and be informed of the study, sign the informed consent in person, willing to follow and be able to complete all test procedures.
- 18-80 years old (inclusive), all genders.
- Histopathologically confirmed grade 1-3a follicular lymphoma (FL) at stage III/IV or extensive stage II disease not suitable for radiotherapy, with at least one evaluable lesion (short axis ≥ 1.5 cm), meeting treatment indications according to GELF criteria or having a strong treatment desire.
- No prior anti-tumor therapy, such as chemotherapy, radiotherapy, immunotherapy or biotherapy (tumor vaccine, cytokine, or growth factor controlling cancer).
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-3.
- Adequate bone marrow and organ function, no serious hematopoietic dysfunction, abnormal heart, lung, liver, kidney function and immune deficiency.
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- Blood routine: White blood cell count ≥ 3.0×109/L, Absolute neutrophil count ≥ 1.5×109/L (use of granulocyte colony stimulating factor is permitted), Hemoglobin ≥ 9.0 g/dL (pre-transfusion or use of recombinant human erythropoietin is permitted), Platelet count ≥ 75×109/L (transfusion is permitted to reach this level). If peripheral blood abnormalities are due to lymphoma infiltration of the bone marrow or spleen, enrollment may be considered at the investigator's discretion.
- Echocardiogram: Left ventricular ejection fraction (LVEF) ≥ 50%.
- Liver function: serum bilirubin ≤ 2.5 times the upper limit of normal value, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times the upper limit of normal value (AST is allowed if liver is involved, ALT ≤ 5 times the upper limit of normal value).
- Renal function: creatinine clearance ≥ 60 mL/min (estimated according to the Cockcroft-Gault formula).
- Coagulation function: INR ≤ 1.5 times the upper limit of normal value; PT and APTT ≤ 1.5 times the upper limit of normal value.
- Life Expectancy of at least 6 months.
- Men and women of childbearing potential must use contraception during the study and for at least 90 days after the last dose of study medication.
Who cannot join
- Central nervous system involvement secondary to lymphoma.
- Known severe allergic reactions to humanized or murine monoclonal antibodies, or known contraindications to any drug in the regimen.
- History of other active malignant diseases within 2 years prior to study entry, but eligibility for inclusion: a) adequately treated carcinoma in situ of the cervix; b) local basal cell carcinoma or squamous cell carcinoma of skin; c) Pre-existing malignant disease that is under control and has undergone local radical treatment (surgical or other forms).
- History of Human Immunodeficiency Virus (HIV) infection and/or other acquired Immunodeficiency syndrome. During screening period, patients with hepatitis B virus (HBV) surface antigen or hepatitis C virus (HCV) antibody positive must further test HBV DNA (no more than 2000 iu/ml) and HCV RNA (not exceed the method detection limit). Those ruling out active HBV or HCV infection are permitted to participate in the study. Carriers of the HBV, those with stable HBV after treatment or cured of HCV are also allowed to be enrolled.
- Any active infections, including but not limited to bacterial, fungal or viral infections, that require systemic anti-infective treatment within 14 days prior to initiation treatment.
- Major surgery was performed within 28 days prior to initiation treatment.
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- Combined with severe or uncontrolled disease, including but not limited to congestive heart failure, uncontrolled hypertension, unstable angina, active peptic ulcer, severe hemorrhagic diseases (such as hemophilia, von willebrand disease) or spontaneous bleeding.
- History of stroke or intracranial hemorrhage within 6 months prior to initiation treatment.
- Continuous treatment with strong and moderate CYP3A inhibitors or CYP3A inducers is required.
- History of severe neurological or psychiatric disorders, including but not limited to dementia or epilepsy.
- Conditions related to drug abuse or medical, psychological and social issues that may interfere with study participation or outcome evaluation.
- Investigator Discretion: Any patient deemed unsuitable for enrollment by the investigator.
- Patients deemed unsuitable for the study by investigators.
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
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310058
Haiyan Yang, MD, 86-0571-88122192, yanghy@zjcc.org.cn
Haifeng Yu, MD, 86-0571-88122192, yuhaifeng5533@dingtalk.com
About this study
Official title: A Prospective, Single-arm, Phase II Study of Zanubrutinib in Combination With GCVP (Obinutuzumab, Cyclophosphamide, Vindesine, Prednisolone) in Previously Untreated Follicular Lymphoma
Previously untreated patients with follicular lymphoma are treated with the ZGCVP regimen (zanubrutinib, obinutuzumab, cyclophosphamide, vindesine, prednisolone) for 6 cycles.
Read the detailed description
This is a prospective, single-arm, multi-center, phase II clinical study aiming at evaluating the efficacy and safety of zanubrutinib with GCVP (obinutuzumab, cyclophosphamide, vindesine, prednisolone) in untreated follicular lymphoma (FL). It includes screening (14 days before the first dose), treatment, and follow-up phases.
Screening: Recruitment subjects are grade 1-3a, stage III/IV or extensive stage II (unsuitable for radiotherapy) FL patients, with measurable lesions (short axis ≥1.5cm), meeting GELF criteria or having strong treatment desire.
Treatment: Patients receive the ZGCVP regimen for 6 cycles (21-day/cycle). Imaging evaluation was conducted at the end of every 2 cycles. Enhanced Computed Tomography (CT) and ultrasound are performed after 2 cycles of the ZGCVP regimen, while interim Positron Emission Tomography (iPET) is performed after 4/6 cycles. Bone marrow examination is required for those with initial bone marrow involvement after achieving Imaging complete response. Efficacy assessment indicators include complete response rate (CR), objection response rate (ORR), duration of response (DOR), progression free survival (PFS), overall survival (OS) and disease transformation rate according to Lugano 2014 criteria. Safety assessment indicators inlude adverse events basing on CTCAE 5.0.
Follow-up: Patients achieving CR at stage II underwent observation directly; those at stage III/IV receive obinutuzumab maintenance every 8 weeks for 2 years until disease progression or withdrawal. Patients with disease progression during treatment switch to second-line therapy.
- Conditions
- BTK Inhibitors, Follicular Lymphoma, Immunochemotherapy
- Being tested
- ZGCVP
- Keywords
- BTK inhibitors, follicular lymphoma, immunochemotherapy, first-line therapy
- Medical subject headings
- Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZGCVPDrug
Also called ZGCOP
Patients receive the ZGCVP regimen (zanubrutinib, obinutuzumab, cyclophosphamide, vindesine, prednisolone) for 6 cycles at the following dose:
- Zanubrutinib: 160mg orally twice daily;
- Obinutuzumab: 1000mg intravenously on days 1, 8, and 15 of cycle 1 and on day 1 of subsequent 5 cycles;
- Cyclophosphamide: 750m/m2 intravenously on days 1 of every cycle;
- Vindesine: 3 mg/m2 (maximum dose 4 mg) intravenously on days 1 of every cycle;
- Prednisolone: 30mg orally three times daily on day 1-5 of every cycle. Patients achieving CR at stage II underwent observation directly; those at stage III/IV receive obinutuzumab maintenance every 8 weeks for 2 years (1000mg intravenously) until disease progression or withdrawal. Patients with disease progression during treatment switch to second-line therapy.
| Study group | Role | What they receive |
|---|---|---|
| zanubrutinib, obinutuzumab, cyclophosphamide, vindesine, prednisolone | Experimental | Patients receive the ZGCVP regimen (zanubrutinib, obinutuzumab, cyclophosphamide, vindesine, prednisolone) for 6 cycles at the following dose:
1. Zanubrutinib: 160mg orally twice daily;
2. Obinutuzumab: 1000mg intravenously on days 1, 8, and 15 of cycle 1 and on day 1 of subsequent 5 cycles;
3. Cyclophosphamide: 750m/m2 intravenously on days 1 of every cycle;
4. Vindesine: 3 mg/m2 (maximum dose 4 mg) intravenously on days 1 of every cycle;
5. Prednisolone: 30mg orally three times daily on day 1-5 of every cycle. Receives: Drug: ZGCVP |
What is being measured
The primary outcome is the main question the study is designed to answer.
CRR
Complete response rate
Measured: 21days after the end of treatment
Secondary outcomes (5)
ORR
Objective response rate
Measured: 21days after the end of treatment
DOR
Duration of response
Measured: the time from the date of initial assessment as complete response (CR) or partial response (PR) until the date of disease progression or death from any cause, whichever occurs first, assessed up to 24 months
PFS
Progression free survival
Measured: the time from the date of initial treatment until the date of disease progression or death from any cause, whichever occurs first, assessed up to 24 months
OS
Overall survival
Measured: the time from the date of initial treatment until the date of death from any cause, assessed up to 24 months
Disease Transformation Rate
The probability of histologically confirmed transformation to aggressive lymphoma among enrolled follicular lymphoma patients
Measured: From the first day of treatment until histological confirmation of transformation, death, or end of study follow-up, whichever occurs first, assessed up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start1 May 2025 (estimated)
- Primary completion1 May 2028 (estimated)
- Study completion1 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BTK InhibitorsStudies of the same condition, open and under way.
- More trials run by Zhejiang Cancer 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
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yang haiyan, Zhejiang Cancer Hospital
- Investigators
- Haiyan Yang, MD, Principal investigator, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06918015
- Sponsor's protocol ID
- ZGCVP
- Status last verified
- Apr 2025
- First submitted
- 20 Mar 2025
- Last updated
- 15 Apr 2025
- 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 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-arm, Phase II Study of Zanubrutinib in Combination With GCVP (Obinutuzumab, Cyclophosphamide, Vindesine, Prednisolone) in Previously Untreated Follicular Lymphoma
- ClinicalTrials.gov ID
- NCT06918015
- Acronym / sponsor ID
- ZGCVP
- Conditions
- BTK Inhibitors, Follicular Lymphoma, Immunochemotherapy
- Keywords
- BTK inhibitors, follicular lymphoma, immunochemotherapy, first-line therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 1 May 2028 (estimated)
- Study completion
- 1 May 2030 (estimated)
- First posted
- 9 Apr 2025 (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.
Previously untreated patients with follicular lymphoma are treated with the ZGCVP regimen (zanubrutinib, obinutuzumab, cyclophosphamide, vindesine, prednisolone) for 6 cycles.
Detailed description
This is a prospective, single-arm, multi-center, phase II clinical study aiming at evaluating the efficacy and safety of zanubrutinib with GCVP (obinutuzumab, cyclophosphamide, vindesine, prednisolone) in untreated follicular lymphoma (FL). It includes screening (14 days before the first dose), treatment, and follow-up phases.
Screening: Recruitment subjects are grade 1-3a, stage III/IV or extensive stage II (unsuitable for radiotherapy) FL patients, with measurable lesions (short axis ≥1.5cm), meeting GELF criteria or having strong treatment desire.
Treatment: Patients receive the ZGCVP regimen for 6 cycles (21-day/cycle). Imaging evaluation was conducted at the end of every 2 cycles. Enhanced Computed Tomography (CT) and ultrasound are performed after 2 cycles of the ZGCVP regimen, while interim Positron Emission Tomography (iPET) is performed after 4/6 cycles. Bone marrow examination is required for those with initial bone marrow involvement after achieving Imaging complete response. Efficacy assessment indicators include complete response rate (CR), objection response rate (ORR), duration of response (DOR), progression free survival (PFS), overall survival (OS) and disease transformation rate according to Lugano 2014 criteria. Safety assessment indicators inlude adverse events basing on CTCAE 5.0.
Follow-up: Patients achieving CR at stage II underwent observation directly; those at stage III/IV receive obinutuzumab maintenance every 8 weeks for 2 years until disease progression or withdrawal. Patients with disease progression during treatment switch to second-line therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| zanubrutinib, obinutuzumab, cyclophosphamide, vindesine, prednisolone | Experimental | Drug: ZGCVPPatients receive the ZGCVP regimen (zanubrutinib, obinutuzumab, cyclophosphamide, vindesine, prednisolone) for 6 cycles at the following dose: 1. Zanubrutinib: 160mg orally twice daily; 2. Obinutuzumab: 1000mg intravenously on days 1, 8, and 15 of cycle 1 and on day 1 of subsequent 5 cycles; 3. Cyclophosphamide: 750m/m2 intravenously on days 1 of every cycle; 4. Vindesine: 3 mg/m2 (maximum dose 4 mg) intravenously on days 1 of every cycle; 5. Prednisolone: 30mg orally three times daily on day 1-5 of every cycle. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Participate in the clinical study voluntarily, fully understand and be informed of the study, sign the informed consent in person, willing to follow and be able to complete all test procedures.
- 18-80 years old (inclusive), all genders.
- Histopathologically confirmed grade 1-3a follicular lymphoma (FL) at stage III/IV or extensive stage II disease not suitable for radiotherapy, with at least one evaluable lesion (short axis ≥ 1.5 cm), meeting treatment indications according to GELF criteria or having a strong treatment desire.
- No prior anti-tumor therapy, such as chemotherapy, radiotherapy, immunotherapy or biotherapy (tumor vaccine, cytokine, or growth factor controlling cancer).
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-3.
Key exclusion criteria (13 listed)
- Central nervous system involvement secondary to lymphoma.
- Known severe allergic reactions to humanized or murine monoclonal antibodies, or known contraindications to any drug in the regimen.
- History of other active malignant diseases within 2 years prior to study entry, but eligibility for inclusion: a) adequately treated carcinoma in situ of the cervix; b) local basal cell carcinoma or squamous cell carcinoma of skin; c) Pre-existing malignant disease that is under control and has undergone local radical treatment (surgical or other forms).
- History of Human Immunodeficiency Virus (HIV) infection and/or other acquired Immunodeficiency syndrome. During screening period, patients with hepatitis B virus (HBV) surface antigen or hepatitis C virus (HCV) antibody positive must further test HBV DNA (no more than 2000 iu/ml) and HCV RNA (not exceed the method detection limit). Those ruling out active HBV or HCV infection are permitted to participate in the study. Carriers of the HBV, those with stable HBV after treatment or cured of HCV are also allowed to be enrolled.
- Any active infections, including but not limited to bacterial, fungal or viral infections, that require systemic anti-infective treatment within 14 days prior to initiation treatment.
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 |
|---|---|---|
| ZGCVPAlso: ZGCOPPatients receive the ZGCVP regimen (zanubrutinib, obinutuzumab, cyclophosphamide, vindesine, prednisolone) for 6 cycles at the following dose: 1. Zanubrutinib: 160mg orally twice daily; 2. Obinutuzumab: 1000mg intravenously on days 1, 8, and 15 of cycle 1 and on day 1 of subsequent 5 cycles; 3. Cyclophosphamide: 750m/m2 intravenously on days 1 of every cycle; 4. Vindesine: 3 mg/m2 (maximum dose 4 mg) intravenously on days 1 of every cycle; 5. Prednisolone: 30mg orally three times daily on day 1-5 of every cycle. Patients achieving CR at stage II underwent observation directly; those at stage III/IV receive obinutuzumab maintenance every 8 weeks for 2 years (1000mg intravenously) until disease progression or withdrawal. Patients with disease progression during treatment switch to second-line therapy. | Drug | zanubrutinib, obinutuzumab, cyclophosphamide, vindesine, prednisolone |
Primary outcome
CRR
Time frame: 21days after the end of treatment
Complete response rate
5 secondary outcomes
ORR
Time frame: 21days after the end of treatment
DOR
Time frame: the time from the date of initial assessment as complete response (CR) or partial response (PR) until the date of disease progression or death from any cause, whichever occurs first, assessed up to 24 months
PFS
Time frame: the time from the date of initial treatment until the date of disease progression or death from any cause, whichever occurs first, assessed up to 24 months
OS
Time frame: the time from the date of initial treatment until the date of death from any cause, assessed up to 24 months
Disease Transformation Rate
Time frame: From the first day of treatment until histological confirmation of transformation, death, or end of study follow-up, whichever occurs first, assessed up to 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 15 Apr 2025.
- Individual participant dataSharing planned: No
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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.
Haiyan Yang, MD principal investigator
Zhejiang Cancer Hospital
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 ZGCVP in people with BTK Inhibitors and Follicular Lymphoma, run by Zhejiang Cancer Hospital 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 13 inclusion and 13 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 15 Apr 2025. 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 Haiyan Yang, MD (86-0571-88122192, yanghy@zjcc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CRR (time frame: 21days after the end of 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 15 Apr 2025.