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

June 16, 2024 updated by: Peking Union Medical College Hospital

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

45

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: OGL
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
Drug: Orelabrutinib, obinutuzumab, lenalidomide
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At the end of cycle 12(the first 6 cycles are 21 days each, and the following 6 cycles are 28 days each)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At the end of therapy(up to 42 weeks)
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
At the end of therapy(up to 42 weeks)
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
At the end of cycle 12(the first 6 cycles are 21 days each, and the following 6 cycles are 28 days each)
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.
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]
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.
From date of signing the informed consent until the date of death from any cause, whichever came first, assessed up to 2 years]
TTR
Time Frame: Up to 2 years
TTR is defined as the time from registration to the first response.
Up to 2 years
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.
Up to 2 years
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.
One month after the end of treatment（up to 46 weeks）

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 20, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

May 27, 2024

First Submitted That Met QC Criteria

June 10, 2024

First Posted (Actual)

June 12, 2024

Study Record Updates

Last Update Posted (Actual)

June 18, 2024

Last Update Submitted That Met QC Criteria

June 16, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PUMCH-NHL-017

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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