Pro-miniCHOP-like Regimen for Treatment-naive Elderly Patients

April 18, 2023 updated by: The First Affiliated Hospital of Soochow University

Prospective Exploratory Clinical Study of Orelabrutinib, Pomalidomide, Rituximab Combined With miniCHOP-like Regimen in Treatment-naive Elderly Patients With DLBCL

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The study will start with an initial 21-days of induction therapy with combination of orelabrutinib, pomalidomide and rituximab(Pro regimen) in eligible patients, following contrast computed temography(CT) to guide the next treatment. Patients whose lesions have 25% or more reduction will next receive Pro-miniCHOP-like regimen for 6 cycles. Patients with reduction less than 25% will receive R-miniCHOP-like regimen also for 6 cycles. After that, maintenance therapy with pomalidomide for two years will be given to patients undergoing Pro-miniCHOP-like regimen.

Study Type

Interventional

Enrollment (Anticipated)

35

Phase

  • Not Applicable

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 Contact Backup

Study Locations

  • China
    • Jiangsu
      • Suzhou, Jiangsu, China, 215006
        • Recruiting
        • The First Affiliated Hospital of Soochow University
        • 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

  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Histopathologically or Cytologically confirmed newly diagnosed untreated DLBCL;
  2. There is at least one radiographically measurable lesion (i.e., ≥ 15mm in diameter);
  3. Age ≥ 70 years;
  4. Life expectancy >3 months;
  5. 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).
  6. Written informed consent obtained from the subject.

Exclusion Criteria:

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

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: rituximab(100mg), orelabrutinib(50mg), pomalidomide(4mg), miniCHOP-like
  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: Rituximab
Rituximab 375mg/m2 ivgtt d1;
Other Names:
  • MabThera
Drug: Orelabrutinib
Orelabrutinib 150mg per day oral administration till progresses or intolerant toxicity;
Other Names:
  • Yinuokai
Drug: Pomalidomide
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.
Other Names:
  • Anyve
Drug: Pro-miniCHOP-like regimen
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.
Drug: R-miniCHOP-like regimen
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Response Rate(ORR) after Pro-miniCHOP-like regimen
Time Frame: At the end of cycle 6 (each cycle is 21 days)
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
Time Frame: At the end of cycle 6 (each cycle is 21 days)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of treatment-emergent adverse events, treatment-related adverse events and serious adverse events
Time Frame: Initiation of study drug until 28 days after last dose
The safety and tolerability of the therapeutic regimen measured by the 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 Survival (OS)
Time Frame: Up to 2 years after the end of last patient's treatment
OS will be assessed from the first drug given to date of death or end of follow-up.
Up to 2 years after the end of last patient's treatment
Progression Free Survival (PFS)
Time Frame: Up to 2 years after the end of last patient's treatment
PFS will be assessed from the first drug given to date of progression, relapse, death or end of follow-up.
Up to 2 years after the end of last patient's treatment
Overall Response Rate(ORR) after Pro induction regimen
Time Frame: At the end of a cycle 1 of induction therapy period (each cycle is 21 days)
The rate of patients who achieved complete response and partial response 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
Time Frame: At the end of a cycle 1 of induction therapy period (each cycle is 21 days)
The rate of patients who achieved complete response after Pro induction regimen.
At the end of a cycle 1 of induction therapy period (each cycle is 21 days)

Collaborators and Investigators

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

Sponsor

The First Affiliated Hospital of Soochow University

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 (Actual)

January 4, 2023

Primary Completion (Anticipated)

July 3, 2025

Study Completion (Anticipated)

July 3, 2026

Study Registration Dates

First Submitted

March 22, 2023

First Submitted That Met QC Criteria

April 10, 2023

First Posted (Actual)

April 12, 2023

Study Record Updates

Last Update Posted (Actual)

April 20, 2023

Last Update Submitted That Met QC Criteria

April 18, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Jinzm 005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing Time Frame

After the end of the study

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

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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