Comparing ZR2 and R-miniCHOP for treating elderly patients with lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the efficacy and safety of a treatment regimen combining zanubrutinib, rituximab, and lenalidomide (ZR2) against a standard regimen of rituximab with low-dose CHOP (R-miniCHOP) in elderly patients aged 70 and older who are unfit or frail. Participants will be randomly assigned to one of the two treatment groups and will receive their respective therapies over six cycles. The study aims to determine which treatment is more effective for this vulnerable population suffering from diffuse large B-cell lymphoma.

Why it matters

Who can join: the full rules

Inclusion Criteria

Patients must satisfy all of the following criteria to be enrolled in the study:

* Histologically-confirmed diffuse large B-cell lymphoma (without central nervous system involvement)
* Eastern Cooperative Oncology Group performance status 0-3
* Aged ≥ 80 years old or aged 70-79 with comprehensive geriatric assessment stratified as unfit or frail
* International normalized ratio and activated partial thromboplastin time are both 1.5 times lower than the upper limits of normal (ULN).
* At least 1 measurable site of disease (defined as lymph nodes with the long diameters longer than 1.5cm, or extra-nodal sites with the long diameters longer than 1.0cm; meanwhile, any lesion site with at least 2 measurable vertical diameters)
* Life expectancy of at least 3 months determined by researchers
* The patient or his or her legal representative must provide written informed consent prior to any special examination or procedure for the research.
* Anti-lymphoma drugs have not been used before (except glucocorticoids).

Exclusion criteria

Presence of any of the following criteria will exclude a patient from enrollment:

* Uncontrolled cardio- and cerebro-vascular disease, blood clotting disorders, connective tissue diseases, serious infectious diseases and other diseases
* Laboratory measures meet the following criteria at screening (unless caused by lymphoma):

  1. Neutrophils\<1.5×10\^9/L
  2. Platelets\<80×10\^9/L (Platelets\<50×10\^9/L in case of bone marrow involvement)
  3. ALT or AST is 2 times higher than the upper limits of normal (ULN), AKP and bilirubin are 1.5 times higher than the ULN.
  4. Creatinine is 1.5 times higher than the ULN or eGFR is lower than 40ml/min/1.73m\^2 (according to Cockcroft-Gault Equation or MDRD Equation).
* HIV-infected patients
* Left ventricular ejection fraction\<50%
* Patients with HbsAg positive are required to have HBV DNA\<1.0×10\^3 IU/ml before entering the group. In addition, if the patient is HBsAg negative but HBcAb positive (regardless of HBsAb status), HBV DNA test is also required, and HBV DNA\<1.0×10\^3 IU/ml is required before entering the group.
* Other anti-tumor treatments (lymphoma or other types of tumors) are currently in progress.
* Patients with psychiatric disorders or patients who are known or suspected to be unable to fully comply with the study protocol
* Require treatment with strong/moderate CYP3A inhibitors or inducers.
* History of stroke or intracranial hemorrhage within 6 months prior to start of therapy
* Inability to swallow capsules or presence of diseases that significantly affect gastrointestinal function, such as malabsorption syndrome, post-bariatric surgery, inflammatory bowel disease and complete or incomplete intestinal obstruction
* Other medical conditions determined by the researchers that may affect the study

Where it's running

• Ruijin Hospital
  Shanghai, Shanghai, China Recruiting

Study contacts

• Study coordinator: Weili ZHAO
• Email: zwl_trial@163.com
• Phone: +862164370045

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Comparing Pola-ZR2 and ZR2 for treating elderly patients with diffuse large B-cell lymphoma

  This study is testing if adding a new drug called polatuzumab vedotin to a standard treatment helps older patients with diffuse large B-cell lymphoma feel better and improve their outcomes.

  Recruiting Phase 3 Ruijin Hospital · Shanghai · NCT06522555

• Polatuzumab Vedotin plus Rituximab with Reduced-dose chemo for frail seniors with DLBCL

  This trial tests whether a gentler, first-line treatment (Polatuzumab Vedotin with Rituximab and reduced-dose chemo) helps older, frail patients with DLBCL stay disease-free longer.

  Recruiting Phase 4 The First Hospital of Jilin University · Changchun, Jilin · NCT07908888

• Glofitamab combo vs Rituximab combo with chemo for relapsed/refractory DLBCL

  This study tests whether glofitamab with chemotherapy (JS203-GemOx) helps patients with relapsed or refractory DLBCL more than rituximab with chemotherapy.

  Recruiting Phase 3 Shanghai Junshi Bioscience Co., Ltd. · Beijing, Beijing Municipality · NCT07808827

• Polatuzumab vedotin with Zanubrutinib, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone in untreated DLBCL (MCD/BN2/N1)

  This study tests a targeted combination therapy to see if it can treat previously untreated DLBCL with specific molecular subtypes.

  Recruiting Phase 2 The First Affiliated Hospital with Nanjing Medical University · Nanjing, Jiangsu · NCT07608978

• Zanubrutinib, rituximab, lenalidomide plus tislelizumab for relapsed/refractory follicular lymphoma

  This trial tests whether adding the PD‑1 blocker tislelizumab to zanubrutinib, rituximab, and lenalidomide helps adults with relapsed or refractory follicular lymphoma who have had at least two prior therapies.

  Recruiting Phase 2 The First Affiliated Hospital with Nanjing Medical University · Nanjing, Jiangsu · NCT07418190

• Zanubrutinib plus rituximab for secondary HLH linked to B‑cell lymphoma

  This test tries zanubrutinib together with rituximab (plus short steroids and ruxolitinib, with emapalumab if needed) to treat people who have secondary HLH caused by B‑cell lymphoma.

  Recruiting Phase 4 The First Affiliated Hospital of Soochow University · Suzhou, Jiangsu · NCT07270835

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.