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New treatment option for Follicular Lymphoma
Official title Zanubrutinib in Combination With Obinutuzumab (ZO) for Newly Diagnosed Follicular Lymphoma
ClinicalTrials.gov ID: NCT06553352
What this study is testing
What is Zanubrutinib combined with Obinutuzumab?
Zanubrutinib combined with Obinutuzumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for follicular lymphoma.
Also referred to as Zanubrutinib combined with Obinutuzumab (ZO).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To evaluate the efficacy and side effects of Zanubrutinib combined with Obinutuzumab (ZO) in the treatment of newly diagnosed follicular lymphoma.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age: ≥18 years old and gender-neutral;
- Follicular lymphoma definitively diagnosed according to the REAL/WHO classification, stage II-IV requiring treatment according to the GELF code;
- ECOG score 0-2;
- Lymphoma how well it works evaluation criteria using Lugano 2014 Lymphoma must have at least one measurable or evaluable lesion: signed informed...
You likely can't join if
- , etc History taking and pre-treatment baseline examination and registration on case report form (CRF) ZO regimen of chemotherapy for 6 cycles...
- HBV-positive serology (concealed carriers: anti-HBeAg +, HbsAg-, anti-HBsAg +/-) Enrollment only if HBV-DNA test is negative;
- Normal major organ function: liver function serum bilirubin ≤ 2.0 × ULN , serum ALT and AST ≤ 2.5 × ULN, renal function: serum Cr ≤ 2.0 × ULN...
- Informed consent (patients must sign an informed consent form for all studies). Exclusion Criteria:
- Medically significant CNS lymphoma or molluscum contagiosum or large cell transformation;
- HIV-positive patients and or HCV active infection (documented by HCV-RNA positive test);
See the full eligibility criteria
- Age: ≥18 years old and gender-neutral;
- Follicular lymphoma definitively diagnosed according to the REAL/WHO classification, stage II-IV requiring treatment according to the GELF code;
- ECOG score 0-2;
- Lymphoma how well it works evaluation criteria using Lugano 2014 Lymphoma must have at least one measurable or evaluable lesion: signed informed consent, people recruited based on inclusion and
- , etc History taking and pre-treatment baseline examination and registration on case report form (CRF) ZO regimen of chemotherapy for 6 cycles, followed by zebrutinib monotherapy orally for 6 months, with observation of...
- HBV-positive serology (concealed carriers: anti-HBeAg +, HbsAg-, anti-HBsAg +/-) Enrollment only if HBV-DNA test is negative;
- Normal major organ function: liver function serum bilirubin ≤ 2.0 × ULN , serum ALT and AST ≤ 2.5 × ULN, renal function: serum Cr ≤ 2.0 × ULN; (unless due to lymphoma);
- Informed consent (patients must sign an informed consent form for all studies). Exclusion Criteria:
- Medically significant CNS lymphoma or molluscum contagiosum or large cell transformation;
- HIV-positive patients and or HCV active infection (documented by HCV-RNA positive test);
- Patients should not have active or uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia Patients should not have transfusion-dependent thrombocytopenia or bleeding disorders Patients should not have...
- Known bleeding disorders (e.g., vascular hemophilia or hemophilia) in combination with warfarin or other vitamin K antagonists require treatment with a potent cytochrome P450 (CYP) 3A inhibitor;
- Patients with acute coronary syndrome within 6 months prior to study entry must not have had a stroke or intracranial hemorrhage within the past 6 months Prior Surgery: no major surgery within 28 days prior to...
- Severe COPD with combined hypoxemia;
- Active bacterial, fungal, and, or viral infections not controlled by systemic therapy;
- In addition to cured basal cell carcinoma of the skin or cervical cancer in situ or early prostate cancer that does not require systemic therapy, or early breast cancer that requires surgery alone. Other malignant...
- Pregnancy and Lactation: Female patients must have a negative serum pregnancy test within 72 hours prior to initiation of regimen therapy and use effective contraception during regimen therapy and for at least 12 weeks...
The study team makes the final eligibility decision.
Where it's taking place
- Xiamen, Fujian, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Xiamen, Fujian, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.