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Trial Title:
Orelabrutinib Combined With Obinutuzumab and Lenalidomide (OGL Regimen) as First-line Treatment for Marginal Zone Lymphoma.
NCT ID:
NCT06454968
Condition:
Marginal Zone Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, B-Cell, Marginal Zone
Lenalidomide
Obinutuzumab
Conditions: Keywords:
Orelabrutinib
Marginal Zone Lymphoma
obinutuzumab
lenalidomide
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Orelabrutinib, obinutuzumab, lenalidomide
Description:
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
Arm group label:
OGL
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).
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking Union Medical College Hospital
Address:
City:
Beijing
Zip:
100730
Country:
China
Status:
Recruiting
Contact:
Last name:
wei Wang
Phone:
+86 13810131294
Email:
wangweipumc@163.com
Start date:
June 20, 2024
Completion date:
June 1, 2028
Lead sponsor:
Agency:
Peking Union Medical College Hospital
Agency class:
Other
Source:
Peking Union Medical College Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06454968
