Can a Three-Drug cocktail replace chemo for follicular lymphoma?
NCT ID NCT07719855
First seen Jul 22, 2026 · Last updated Jul 23, 2026 · Updated 1 time
Summary
This phase 3 trial is testing whether a combination of three targeted drugs—orelabrutinib, obinutuzumab, and lenalidomide—can work as well as or better than standard chemotherapy for people with previously untreated follicular lymphoma. The goal is to see if this chemo-free approach can control the cancer while causing fewer side effects. The study enrolls adults with grade 1-3A follicular lymphoma who have not received prior treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a combination of orelabrutinib, obinutuzumab, and lenalidomide
- What this could lead to
- If successful, this drug combination could offer a chemotherapy-free option for follicular lymphoma, potentially improving outcomes and quality of life.
- What could go wrong
- This is an early-phase trial, and the combination may cause unexpected side effects or fail to outperform standard chemotherapy. Results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
About 652 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Jul 2026
An estimate. Start dates often move.
- Expected to finish
-
Dec 2033
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Subjects with histopathologically confirmed follicular lymphoma (FL) Grade 1-3A; 2. Subjects who have never received prior anti-lymphoma therapy; 3. Age ≥ 18 years old; 4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2; 5. Adequate bone marrow, hepatic and renal function, defined as: 1)Absolute neutrophil count (ANC) \> 1,000/μL; platelet count \> 50,000/mm³; hemoglobin \> 80 g/dL; 2)Alanine transaminase (ALT) and aspartate transaminase (AST) \< 3 × upper limit of normal (ULN); 3)Total serum bilirubin \< 1.5 × ULN (patients with Gilbert syndrome are eligible); serum creatinine \< 2 × ULN OR creatinine clearance \> 50 mL/min; 6、Tumor tissue available for testing (fresh tissue preferred; archived paraffin-embedded tissue is acceptable); 7、Women of childbearing potential with a negative pregnancy test prior to Day 1 of treatment, who agree to use effective contraception throughout the study period and for at least 1 year after completion of study treatment; 8、Written informed consent obtained from the subject or their legal authorized representative prior to any study-specific examinations or procedures. Exclusion Criteria: 1. Uncontrolled cardiovascular and cerebrovascular diseases, coagulation disorders, connective tissue diseases, severe infectious diseases, etc. 2. Abnormal laboratory parameters at screening (unless attributed to follicular lymphoma): 1. Absolute neutrophil count \< 1.5 × 10⁹/L 2. Platelet count \< 80 × 10⁹/L; if bone marrow involvement is present, platelet count \< 50 × 10⁹/L 3. Alanine transaminase (ALT) or aspartate transaminase (AST) \> 2 × upper limit of normal (ULN); alkaline phosphatase (AKP) or bilirubin \> 1.5 × ULN 4. Serum creatinine \> 1.5 × ULN OR estimated glomerular filtration rate (eGFR) \< 40 mL/min/1.73 m² (calculated via the Cockcroft-Gault equation or Modification of Diet in Renal Disease \[MDRD\] equation) 3. Human immunodeficiency virus (HIV)-positive subjects. 4. Left ventricular ejection fraction (LVEF) \< 50%. 5. HBV screening requirements: Subjects with positive hepatitis B surface antigen (HBsAg) must undergo HBV DNA testing; those with HBV DNA \< 10³ IU/mL are eligible for enrollment. Subjects with negative HBsAg but positive hepatitis B core antibody (HBcAb) (regardless of hepatitis B surface antibody \[HBsAb\] status) must also undergo HBV DNA testing; those with HBV DNA \< 10³ IU/mL are eligible for enrollment. 6. Receiving concurrent anti-tumor therapy (for lymphoma or other malignancies). 7. Subjects with psychiatric disorders, or those with known/suspected poor compliance to the study protocol. 8. Requiring continuous treatment with strong or moderate CYP3A inhibitors or CYP3A inducers (see Appendix 3). Subjects who have taken strong/moderate CYP3A inhibitors or inducers within 7 days prior to the first dose of study drug (or within less than 5 half-lives of such medications) are excluded. 9. History of stroke or intracranial hemorrhage within 6 months before the first dose of study drug. 10. Inability to swallow capsules, or presence of diseases that significantly impair gastrointestinal function, such as malabsorption syndrome, bariatric surgery, inflammatory bowel disease, partial or complete intestinal obstruction. Other uncontrolled concomitant medical conditions deemed by the investigator to interfere with study participation. Any life-threatening disease, medical condition or organ dysfunction that may compromise subject safety, interfere with the absorption or metabolism of oral targeted agents, or expose study outcomes to excessive risk, as judged by the investigator.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Follicular lymphoma (FL) are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Ruijin Hosiptal
Shanghai, Shanghai Municipality, 20025, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- New drug combo aims to outsmart recurring lymphoma
- New combo pill attack aims to control blood cancers
- Smart blood pressure cuffs could protect cancer patients from heart risks
- New cell therapy CT1182 takes on tough lymphoma
- New hope for Tough-to-Treat lymphoma: experimental drug combo enters phase 3 trial
- Chemo-free triplet aims to outsmart incurable lymphoma