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New treatment option for Follicular Lymphoma
Official title Comparison Between Local Radiotherapy Alone or Combined With Obinutuzumab in Early Stage Follicular Lymphoma: the GAZEBO Trial From the Fondazione Italiana Linfomi
ClinicalTrials.gov ID: NCT05929222
What this study is testing
- What it's testing
- Prospective, multicenter, open label, phase III randomized clinical trial in previously untreated Follicular Lymphoma in early stage. Patients will be randomized to receive Radiotherapy or Radiotherapy plus Obinutuzumab.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
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
- Histological documented diagnosis of Follicular Lymphoma grade I-IIIA as defined in the 2017 edition of World Health Organization (WHO)
- Ann Arbor Stage IA or IIA (includible in one radiation field), or IE, non-bulky (\<7 cm). Stage must be determined by PET/CT scan (Appendix 2)
- Patients performing PET before surgery can also be enrolled without repeating PET after surgery
- No previous treatment except for steroid pre-treatment
- FLIPI \< 2, FLIPI2 ≤ 2
You likely can't join if
- Histological diagnosis of Follicular lymphoma grade IIIb
- Staging \>II or B symptoms or bulky disease (\> 7 cm)
- Stage II with distant involved sites, not includible in a single radiation field
- Primary cutaneous follicular lymphoma
- Known HIV positivity
- Positive serology for hepatitis C (HC) defined as a positive test for HCAb, in which case reflexively perform a HC RNA on the same sample to confirm...
See the full eligibility criteria
Who can join
- Histological documented diagnosis of Follicular Lymphoma grade I-IIIA as defined in the 2017 edition of World Health Organization (WHO)
- Ann Arbor Stage IA or IIA (includible in one radiation field), or IE, non-bulky (\<7 cm). Stage must be determined by PET/CT scan (Appendix 2)
- Patients performing PET before surgery can also be enrolled without repeating PET after surgery
- No previous treatment except for steroid pre-treatment
- FLIPI \< 2, FLIPI2 ≤ 2
- Age ≥ 18 years
- Negative bone marrow biopsy
- Qualitative/quantitative PCR centralized assessment of BCL2/IGH positive cells in peripheral blood (PB), bone marrow (BM).
- Centralized revision of the lymph node biopsy with FISH for t(14;18)
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2
- At least one site of measurable nodal disease pre-biopsy ≥ 2.0 cm in the longest transverse diameter as determined by CT scan or ultrasonography
- Adequate renal function defined as follows:
- Creatinine clearance ≥ 40 mL/min (Cockcroft-Gault formula)
- Adequate hepatic function per local laboratory reference range as follows:
- Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3.0 x UNL
- Bilirubin ≤1.5 x UNL (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin)
- Subject understands and voluntarily signs an informed consent form approved by an Independent National Ethics Committee (NEC), prior to the initiation of any screening or study-specific procedures
- Subject must be able to adhere to the study visit schedule and other protocol requirements
- Life expectancy ≥ 3 months
- Fertility and pregnancy prevention criteria
- Women must be:
- postmenopausal for at least 1 year (must not have had a natural menses for at least 12 months)
- surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy),
- completely abstinent (periodic abstinence from intercourse is not permitted) or if sexually active, be practicing a highly effective method of birth control (e.g., prescription oral contraceptives, contraceptive...
- Women of childbearing potential must have a negative pregnancy test at screening
- Men with female partners of childbearing potential: men must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of \< 1% per year during the treatment period...
- Male even if surgically sterilized (i.e., status post vasectomy) must agree to 1 of the following
- practice effective barrier contraception during the entire study treatment period and through 3 months after the last dose of study drug, or
- agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, post ovulation methods for the female...
What rules you out
- Histological diagnosis of Follicular lymphoma grade IIIb
- Staging \>II or B symptoms or bulky disease (\> 7 cm)
- Stage II with distant involved sites, not includible in a single radiation field
- Primary cutaneous follicular lymphoma
- Known HIV positivity
- Positive serology for hepatitis C (HC) defined as a positive test for HCAb, in which case reflexively perform a HC RNA on the same sample to confirm the result, if negative, the patient is eligible.
- Positive serology for Hepatitis B (HB) defined as a positive test for HBsAg. In addition, if negative for HBsAg but HBcAb positive (regardless of HBsAb status), a quantitative HBVDNA test will be performed and if...
- Central Nervous System (CNS) involvement with lymphoma
- Significant history of neurologic, psychiatric, endocrinological, metabolic, immunologic, or hepatic disease that would preclude participation in the study or compromise ability to give informed consent
- Any history of other active malignancies within 3 years prior to study entry, except for adequately treated in situ carcinoma of the cervix uterine, basal cell carcinoma of the skin or localized squamous cell carcinoma...
- Evidence of other clinically significant uncontrolled condition(s) including, but not limited to:
- Uncontrolled and/or active systemic infection (viral, bacterial or fungal)
- Chronic hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment.
- If female, the patient is pregnant or breast-feeding
- Patients participating in other clinical studies.
The study team makes the final eligibility decision.
Where it's taking place
- Sassuolo, Modena (MO), Italy
- Alessandria, Italy
- Avellino, Italy
- Aviano, Italy
- Bari, Italy
- Biella, Italy
- Brescia, Italy
- Cagliari, Italy
- Candiolo, Italy
- Castelfranco Veneto, Italy
- Catania, Italy
- Cuneo, Italy
- Florence, Italy
- Ivrea, Italy
- Latina, Italy
- Meldola, Italy
- Messina, Italy
- Milan, Italy
- Modena, Italy
- Monza, Italy
+ 20 more site(s).
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 Sassuolo, Modena (MO), Italy; Alessandria, Italy; Avellino, Italy; Aviano, Italy; Bari, Italy; Biella, Italy and 34 more location(s). 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.