NCT05809180

Brief Summary

The proposed study is a prospective, single-center and open-ended study in patients over the age of 70 with treatment-naive diffuse large B-cell lymphoma (DLBCL). This study intends to explore a new treatment pattern using Pro-miniCHOP-like regimen and simultaneously evaluate its safety and efficacy for future clinical practice.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
2mo left

Started Jan 2023

Longer than P75 for not_applicable

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 Progress97%
Jan 2023Jul 2026

Study Start

First participant enrolled

January 4, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 22, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 12, 2023

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 3, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 3, 2026

Expected
Last Updated

April 20, 2023

Status Verified

February 1, 2023

Enrollment Period

2.5 years

First QC Date

March 22, 2023

Last Update Submit

April 18, 2023

Conditions

Diffuse Large B Cell Lymphoma

Keywords

Diffuse Large B-Cell LymphomaOrelabrutinibpomalidomideRituximab

Outcome Measures

Primary Outcomes (2)

  • Overall Response Rate(ORR) after Pro-miniCHOP-like regimen

    The rate of patients who achieved complete response and partial response after Pro-miniCHOP-like regimen.

    At the end of cycle 6 (each cycle is 21 days)

  • Complete Response Rate(CRR) after Pro-miniCHOP-like regimen

    The rate of patients who achieved complete response after Pro-miniCHOP-like regimen.

    At the end of cycle 6 (each cycle is 21 days)

Secondary Outcomes (5)

  • Incidence of treatment-emergent adverse events, treatment-related adverse events and serious adverse events

    Initiation of study drug until 28 days after last dose

  • Overall Response Rate(ORR) after Pro induction regimen

    At the end of a cycle 1 of induction therapy period (each cycle is 21 days)

  • Complete Response Rate(CRR) after Pro induction regimen

    At the end of a cycle 1 of induction therapy period (each cycle is 21 days)

  • Overall Survival (OS)

    Up to 2 years after the end of last patient's treatment

  • Progression Free Survival (PFS)

    Up to 2 years after the end of last patient's treatment

Study Arms (1)

rituximab(100mg), orelabrutinib(50mg), pomalidomide(4mg), miniCHOP-like

EXPERIMENTAL

1. Phase I(induction therapy): Patients receive Rituximab on day 1, Pomalidomide on days 1-7 and oral administration of Orelabrutinib per day. 2. Phase II(stratified response therapy): Part A: (25% or more reduction): Patients receive Pro-miniCHOP-like regimen every 21 days for 6 cycles.(Rituximab on day 1, Pomalidomide on days 1-7, Orelabrutinib per day till progression or intolerant toxicity, Cyclophosphamide on day 2, Doxorubicin/Doxorubicin Liposome on day 2, Vindesine on day 2 and Dexamethasone on days 2-6). Part B: (reduction less than 25%): Patients receive R-miniCHOP-like regimen every 21 days for 6 cycles.(Rituximab on day 1, Cyclophosphamide on day 2, Doxorubicin/Doxorubicin Liposome on day 2, Vindesine on day 2 and Dexamethasone on days 2-6). 3. Phase III(maintenance and follow-up): Patients take Pomalidomide orally on days 1-7 in a cycle of 21 days for 2 years.

Drug: RituximabDrug: OrelabrutinibDrug: PomalidomideDrug: Pro-miniCHOP-like regimenDrug: R-miniCHOP-like regimen

Interventions

RituximabDRUG

Rituximab 375mg/m2 ivgtt d1;

Also known as: MabThera
rituximab(100mg), orelabrutinib(50mg), pomalidomide(4mg), miniCHOP-like
OrelabrutinibDRUG

Orelabrutinib 150mg per day oral administration till progresses or intolerant toxicity;

Also known as: Yinuokai
rituximab(100mg), orelabrutinib(50mg), pomalidomide(4mg), miniCHOP-like
PomalidomideDRUG

Pomalidomide 4mg d1-7 each cycle. After Phase II of treatment, single agent pomalidomide 4 mg d1-d7 in 21-day cycles for 2 years.

Also known as: Anyve
rituximab(100mg), orelabrutinib(50mg), pomalidomide(4mg), miniCHOP-like
Pro-miniCHOP-like regimenDRUG

rituximab 375mg/m2 ivgtt d1; orelabrutinib 150mg per day oral administration till progresses or intolerant toxicity; pomalidomide 4mg d1-7; cyclophosphamide 400mg/m2 ivgtt d2; doxorubicin 25mg/m2 ivgtt d2/ doxorubicin liposome 15 mg/m2 ivgtt d2; vindesine 2mg ivgtt d2; dexamethasone 10mg ivgtt d2-6.

rituximab(100mg), orelabrutinib(50mg), pomalidomide(4mg), miniCHOP-like
R-miniCHOP-like regimenDRUG

rituximab 375mg/m2 ivgtt d1; cyclophosphamide 400mg/m2 ivgtt d2; doxorubicin 25mg/m2 ivgtt d2/ doxorubicin liposome 15 mg/m2 ivgtt d2; vindesine 2mg ivgtt d2; dexamethasone 10mg ivgtt d2-6.

rituximab(100mg), orelabrutinib(50mg), pomalidomide(4mg), miniCHOP-like

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Histopathologically or Cytologically confirmed newly diagnosed untreated DLBCL;
  • There is at least one radiographically measurable lesion (i.e., ≥ 15mm in diameter);
  • Age ≥ 70 years;
  • Life expectancy \>3 months;
  • Patients with proper organic function (alanine aminotransferase, bilirubin, creatinine \< 3 times the upper limit of normal; cardiac ejection fraction ≥ 50%; SPO2\>90% under non-oxygenated conditions).
  • Written informed consent obtained from the subject.

You may not qualify if:

  • Patients with severe liver and kidney dysfunction (alanine aminotransferase, bilirubin, creatinine \> 3 times the upper limit of normal);
  • Patients with organic heart disease with clinical symptoms or cardiac dysfunction (NYHA grade ≥2);
  • Uncontrolled active infection;
  • Patients with central nervous system DLBCL;
  • A history of vascular embolism;
  • Co-existence of other tumors;
  • Systemic corticosteroid therapy is needed;
  • Any other psychological conditions that prevent patients from participating in the study or signing the informed consent form.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

Rituximaborelabrutinibpomalidomide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Central Study Contacts

Zhengming Jin

CONTACT

67781856jinzhengming519519@163.com

Changju Qu

CONTACT

67781856qcj310@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2023

First Posted

April 12, 2023

Study Start

January 4, 2023

Primary Completion

July 3, 2025

Study Completion (Estimated)

July 3, 2026

Last Updated

April 20, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will share

All the data would be available at the First Affiliated Hospital and other researchers after the end of the study.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
After the end of the study

Locations

CN(1)