Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06454968

Orelabrutinib Combined With Obinutuzumab and Lenalidomide (OGL Regimen) as First-line Treatment for Marginal Zone Lymphoma.

This is a multicenter prospective single arm phase II study, and the purpose of this study is to evaluate the safety and efficacy of orelabrutinib combined with obinutuzumab and lenalidomide in untreated marginal zone lymphoma. The primary objective was the best complete response rate (CRR).

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Marginal Zone Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, B-Cell, Marginal Zone Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location status: Recruiting

Location contact

wei Wang

CONTACT

[email protected]

+86 13810131294

About this study

Marginal zone lymphomas (MZL) are a type of lymphoma that originates from the marginal zone tissue of the lymphoid follicles (Mucosa-associated lymphoid tissue, MALT), and include three subtypes: MALT lymphoma, nodal MZL, and splenic MZL. The incidence of MZL is second only to diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL), accounting for approximately 7.8% of all non-Hodgkin lymphomas (NHL). MZL is considered an indolent lymphoma, with patients generally having a better overall survival prognosis. Despite this, some patients still face the challenges of disease relapse or transformation into large cell lymphoma, leading to a poor prognosis.

We conduct this prospective, phase II, single-arm clinical study to initially explore the efficacy and safety of Orelabrutinib combined with obinutuzumab and lenalidomide in patients with previously untreated marginal zone lymphoma. The patients will be treated with 6 cycles of OGL regimen. Patients with CR/PR after 6 cycles of OGL treatment will be treated with 6 cycles of single-agent orelabrutinib regimen.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Orelabrutinib, obinutuzumab, lenalidomide

Drug

Orelabrutinib: 150mg qd d1-d21/C1-C6 obinutuzumab: 1000mg iv d1,d8,d15/c1, 1000mg iv d1/C2-C6 lenalidomide：25mg po qd d1-14/C1-C6 Orelabrutinib: 150mg qd d1-d28/C7-C12

Primary outcomes

  1. the best complete response rate

    Time frame: At the end of cycle 12(the first 6 cycles are 21 days each, and the following 6 cycles are 28 days each)

    CRR is defined as the proportion of patients with a best response of CR

Secondary outcomes

  1. ORR

    Time frame: At the end of therapy(up to 42 weeks)

    ORR is defined as the proportion of patients with a response of CR or PR

  2. CRR

    Time frame: At the end of therapy(up to 42 weeks)

    CRR is defined as the proportion of patients with a best response of CR

  3. The best ORR

    Time frame: At the end of cycle 12(the first 6 cycles are 21 days each, and the following 6 cycles are 28 days each)

    The best ORR is defined as the proportion of patients with a best response of CR or PR

  4. 2 years progression-free survival Progression free survival (PFS)

    Time frame: From date of signing the informed consent until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years]

    PFS is defined as the time from registration to the first occurrence of progression or relapse as assessed by the investigator, or death from any cause. PFS for patients without disease progression, relapse, or death will be censored at the time of the last tumor assessment.

  5. 2 years overall survival

    Time frame: From date of signing the informed consent until the date of death from any cause, whichever came first, assessed up to 2 years]

    Overall survival is defined as the period from the induction registration to death from any cause. Patients who have not died until the time of the analysis will be censored at their last contact date.

  6. TTR

    Time frame: Up to 2 years

    TTR is defined as the time from registration to the first response.

  7. Duration of Response (DOR)

    Time frame: Up to 2 years

    Duration of response as defined as the period from the first response (at least PR) to treatment until evidence of disease progression, relapse or death of any cause. Patients alive without progression and relapse will be censored at the latest tumor assessment date or the stopping date.

  8. The occurrence of adverse events and serious adverse events

    Time frame: One month after the end of treatment（up to 46 weeks）

    Adverse events will be graded by the investigator according to the NCI-CTCAE Version 5.0.

Study contacts

Contact information is provided by the study sponsor or research team.

Jiayue Li

CONTACT

[email protected]

+86 1069156874

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study title

Orelabrutinib Combined With Obinutuzumab and Lenalidomide (OGL Regimen) as First-line Treatment for Marginal Zone Lymphoma：a Multicenter Prospective Single Arm Trial

Important dates

Study start
2024
Primary completion
2026
Study completion
2028
First posted
Jun 12, 2024
Registry last updated
Jun 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.