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

Sponsor
The First Affiliated Hospital of Soochow University
Study ID
NCT05809180
Status
Recruiting
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Conditions

  • Diffuse Large B Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
70 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    Rituximab 375mg/m2 ivgtt d1;
  • Orelabrutinib — DRUG
    Orelabrutinib 150mg per day oral administration till progresses or intolerant toxicity;
  • Pomalidomide — DRUG
    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.
  • Pro-miniCHOP-like regimen — DRUG
    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.
  • R-miniCHOP-like regimen — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jan 4, 2023
Status verified
Feb 2023
Primary completion
Jul 3, 2025
Completion
Jul 3, 2026

Study Design

Enrollment
35 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

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

Central Contacts

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