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New treatment option for Follicular Lymphoma
Official title Orelabrutinib Plus Rituximab Followed by Maintenance With Orelabrutinib for Relapsed and Refractory Follicular Lymphoma(RR FL)
ClinicalTrials.gov ID: NCT04989621
What this study is testing
What is Orelabrutinib and Rituximab?
Orelabrutinib and Rituximab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for follicular lymphoma.
Also referred to as induction treatment.
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
- This phase 2 trial studies the efficacy and safety of orelabrutinib plus rituximab followed by maintenance with orelabrutinib for relapsed and refractory follicular lymphoma(RR FL)
- 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
- Histologically confirmed grade 1, 2, or 3A FL;
- Patients received prior anti-lymphoma treatment;
- At least one evaluable lesion according to 2014 Lugano criteria;
- Age 18 years or older;
- Eastern Cooperative Oncology Group (ECOG) of 0-2;
You likely can't join if
- Patients who required warfarin or had a history of stroke or intracranial hemorrhage within 6 months, active transformed disease;
- Histological transformation of follicular lymphoma;
- Known central nervous system lymphoma;
- Received a prior allogeneic hematopoietic stem cell transplant. Prior autologous hematopoietic stem cell transplant is allowed;
- people who have received prior treatment with ibrutinib, or other BTK inhibitors;
- Uncontrolled active infection, with the exception of tumor-related B symptom fever;
See the full eligibility criteria
- Histologically confirmed grade 1, 2, or 3A FL;
- Patients received prior anti-lymphoma treatment;
- At least one evaluable lesion according to 2014 Lugano criteria;
- Age 18 years or older;
- Eastern Cooperative Oncology Group (ECOG) of 0-2;
- Life expectancy \> 3 months;
- Able to participate in all required study procedures;
- Proper functioning of the major organs:
- Patients who required warfarin or had a history of stroke or intracranial hemorrhage within 6 months, active transformed disease;
- Histological transformation of follicular lymphoma;
- Known central nervous system lymphoma;
- Received a prior allogeneic hematopoietic stem cell transplant. Prior autologous hematopoietic stem cell transplant is allowed;
- people who have received prior treatment with ibrutinib, or other BTK inhibitors;
- Uncontrolled active infection, with the exception of tumor-related B symptom fever;
- Prior nitrosoureas within 6 weeks, chemotherapy within 3 weeks, therapeutic anticancer antibodies within 4 weeks, radio- or toxin-immunoconjugates within 10 weeks, radiation therapy or other investigational agents...
- people who progressed or become refractory while on treatment with PI3K inhibitors are excluded. However, people who were responding to PI3K inhibitors, but had treatment discontinued due to toxicity, are eligible;
- Patients require treatment with strong CYP3A inhibitors;
- Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of Screening;
- Patients with active hepatitis B or active hepatitis C. Patients who are positive for hepatitis B Surface Antigen (HBsAg) or hepatitis C Virus (HCV) antibodies at screening stage must pass further detection of hepatitis...
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, 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 Guangzhou, Guangdong, 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.