Combination treatment for marginal zone 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 multicenter, prospective, single-arm phase II study evaluates the safety and efficacy of a combination of orelabrutinib, obinutuzumab, and lenalidomide in patients with untreated marginal zone lymphoma. The study aims to determine the best complete response rate after administering six cycles of the OGL regimen. Patients who achieve a complete or partial response will continue treatment with orelabrutinib alone for an additional six cycles. The study focuses on a specific type of B-cell non-Hodgkin lymphoma that can be challenging to treat effectively.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥ 18 years, either sex.
* Histopathologically confirmed B-cell non-Hodgkin lymphoma MZL (splenic, nodal, or extra-nodal).
* At least 1 measurable lesion
* Eligible for treatment: meets the GELF criteria, or has clinical symptoms/organ dysfunction related to the disease
* Patients who are not suitable for local radiotherapy or whose condition progresses after local treatment, and those not suitable for local radiotherapy include the following situations:

  * Ann Arbor non-continuous Stage II or Stage III-IV non-gastric MALT and nodal MZL
  * SMZL (Splenic Marginal Zone Lymphoma)
  * Gastric MALT with Lugano Stage II2/IIE/IV
* ECOG performance status (PS) score of 0-2.
* Expected survival time is ≥3 months
* Sign the Informed consent

Exclusion Criteria:

* Currently has other malignant tumors;
* Lymphoma involving the central nervous system
* Allergic to any of the study drugs;
* Active infection or uncontrolled HBV infection (DNA\>105/ml), HIV/AIDS, or other severe infectious diseases;
* Pregnant or lactating women and women of childbearing age who are unwilling to use contraception;
* Any other conditions deemed unsuitable for participation in this trial by the investigator.

Where it's running

• Peking Union Medical College Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Jiayue Li
• Email: pumchkyc@126.com
• Phone: +86 1069156874

Similar studies

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

• Orelabrutinib and Obinutuzumab for Treating Marginal Zone Lymphoma

  This study is testing a new treatment combining Orelabrutinib and Obinutuzumab for people with previously untreated Marginal Zone Lymphoma to see if it works better and is safer than traditional chemotherapy.

  Recruiting Phase 2 Huai'an First People's Hospital · Huai'an, Jiangsu · NCT06566807

• Orelabrutinib with Obinutuzumab and Short-Course Venetoclax in Treatment-Naïve Mantle Cell Lymphoma

  This trial tests whether a combo of orelabrutinib, obinutuzumab, and a short course of venetoclax is safe and effective for adults with newly diagnosed mantle cell lymphoma.

  Recruiting at 2 sites Phase 2 The First Affiliated Hospital with Nanjing Medical University · Changzhou, Jiangsu and 1 other locations · NCT07719556

• Orelabrutinib for adults with early-stage untreated marginal zone lymphoma

  This trial will try orelabrutinib, a selective oral BTK inhibitor, as first-line treatment for adults with stage I–II marginal zone lymphoma to see if it works and is safe.

  Recruiting at 14 sites Phase 2 Institute of Hematology & Blood Diseases Hospital, China · Guangzhou, Guangdong and 13 other locations · NCT07441993

• Orelabrutinib combined with BR/G for untreated Marginal Zone Lymphoma

  This study is testing if a new drug called Orelabrutinib, combined with other treatments, can help younger and older patients with untreated Marginal Zone Lymphoma feel better and have fewer side effects.

  Recruiting Phase 2 First Affiliated Hospital of Zhejiang University · Hangzhou, Zhejiang · NCT06504940

• Combining Orelabrutinib and Rituximab for Treating Marginal Zone Lymphoma

  This study is testing if combining two medications, Orelabrutinib and Rituximab, can help adults with Marginal Zone Lymphoma who haven't responded to other treatments or can't have local therapy.

  Recruiting The First Affiliated Hospital of Xiamen University · Xiamen, Fujian · NCT06478472

• Combining obinutuzumab and lenalidomide for treating relapsed marginal zone lymphoma

  This study is testing a combination of two medications, obinutuzumab and lenalidomide, to see if they can help people with relapsed marginal zone lymphoma feel better.

  Recruiting Phase 2 Institute of Hematology & Blood Diseases Hospital, China · Tianjin, Tian · NCT05846750

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.