NCT06566807

Brief Summary

This is a multi-center, prospective study. The main purpose is to evaluate the efficacy and safety of Orelabrutinib combined with Obinutuzumab for previously untreated MZL.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for phase_2

Timeline
27mo left

Started Aug 2024

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress43%
Aug 2024Aug 2028

First Submitted

Initial submission to the registry

August 14, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 22, 2024

Completed
3 days until next milestone

Study Start

First participant enrolled

August 25, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2026

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2028

Last Updated

August 22, 2024

Status Verified

August 1, 2024

Enrollment Period

2 years

First QC Date

August 14, 2024

Last Update Submit

August 20, 2024

Conditions

Marginal Zone Lymphoma

Keywords

orelabrutinibMarginal Zone Lymphoma

Outcome Measures

Primary Outcomes (1)

  • Overall response rate (ORR)

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

    At the end of Cycle 6 (each cycle is 28 days)

Secondary Outcomes (9)

  • the complete response rate

    (up to 2 year)

  • BOR

    Up to 2 years

  • Duration of Response (DOR)

    [ Time Frame: Up to 3 years ]

  • TTR

    [ Time Frame: Up to 3 years ]

  • 24-month time to CR TTCR24

    Up to 2 years

  • +4 more secondary outcomes

Study Arms (1)

O2

EXPERIMENTAL
Drug: Orelabrutinib, obinutuzumab

Interventions

Orelabrutinib, obinutuzumabDRUG

orelabrutinib，150mg，D1-D28 obinutuzumab，1000mg，D1、D8、D15/cycle1 D1/cycle2-6 . The patients will be treated with 6 cycles of O2 regimen. Patients with CR/PR after 6 cycles of O2 treatment will be treated with 1 year of single-agent orelabrutinib regimen.

O2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged ≥18 years, gender not limited;
  • Histopathologically confirmed CD20-positive marginal zone lymphoma including MALT, SMZL, NMZL;
  • MZL that has progressed, recurred, or is not suitable for local treatment after previous local treatment (local treatments include surgery, radiotherapy, Helicobacter pylori treatment, and hepatitis C treatment);
  • ECOG 0-2;
  • Indication for treatment as judged by the investigator (symptomatic, with cytopenia, at risk of end-organ damage, bulky disease, persistent progression, or patient\'s desire for treatment);
  • Major organ function meets the following criteria: a) Complete blood count: Absolute neutrophil count ≥1.5×10\^9/L, platelets ≥75×10\^9/L, hemoglobin ≥75g/L; if accompanied by bone marrow invasion, absolute neutrophil count ≥1.0×10\^9/L, platelets ≥50×10\^9/L, hemoglobin ≥50g/L; b) Blood biochemistry: Total bilirubin ≤1.5 ULN, AST or ALT ≤2 ULN; serum creatinine ≤1.5 ULN; serum amylase ≤ULN; c) Coagulation function: International normalized ratio (INR) ≤1.5 ULN.
  • Expected survival time ≥3 months;
  • Voluntarily sign a written informed consent form before the trial screening.

You may not qualify if:

  • Currently or previously diagnosed with other malignant tumors, unless curative treatment has been performed and there is evidence of no recurrence or metastasis within the last 5 years;
  • Lymphoma involving the central nervous system or transformation to a higher grade;
  • Active bleeding within 2 months prior to screening, or currently taking anticoagulant medications, or the investigator considers there to be a definite bleeding tendency;
  • Major surgery within 6 weeks prior to screening or minor surgery within 2 weeks prior to screening;
  • Active infection or uncontrolled HBV (positive for HBsAg and/or HBcAb and positive for HBV DNA titer), HCV Ab positive, HIV/AIDS, or other serious infectious diseases;
  • Any mental or cognitive disorder that may limit the understanding, execution, and compliance with the informed consent form and the study;
  • Pregnant or lactating women and women of childbearing age who are unwilling to take contraceptive measures;
  • Need to continuously take drugs with moderate to severe inhibitory or strong inductive effects on cytochrome P450 CYP3A;
  • Other conditions that the investigator considers unsuitable for participating in this trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University#Huai'an First People's Hospital#

Huai'an, Jiangsu, 210000, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, B-Cell, Marginal Zone

Interventions

orelabrutinibobinutuzumab

Condition Hierarchy (Ancestors)

Lymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Central Study Contacts

Chunling Wang

CONTACT

15189552696wcl6506@163.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

August 14, 2024

First Posted

August 22, 2024

Study Start

August 25, 2024

Primary Completion (Estimated)

August 10, 2026

Study Completion (Estimated)

August 10, 2028

Last Updated

August 22, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)