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

NCT06454968 | Recruiting Phase 2

• 1 other identifier: PUMCH-NHL-017
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Marginal Zone Lymphoma

Keywords

Orelabrutinib; Marginal Zone Lymphoma; obinutuzumab; lenalidomide

Outcome Measures

Primary Outcomes (1)

• the best complete response rate

  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 Outcomes (8)

• ORR

  At the end of therapy(up to 42 weeks)

• CRR

  At the end of therapy(up to 42 weeks)

• The best ORR

  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)

  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

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

Study Arms (1)

OGL

EXPERIMENTAL

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

Interventions

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

OGL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, B-Cell, Marginal Zone

Interventions

orelabrutinib; obinutuzumab; Lenalidomide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Jiayue Li

CONTACT

+86 1069156874; pumchkyc@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2024
• First Posted: June 12, 2024
• Study Start: June 20, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2028
• Last Updated: June 18, 2024

Record last verified: 2024-05

Locations

CN (1)