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R2 and Combination Chemotherapy Versus R and Combination Chemotherapy in Newly Diagnosed Highly Aggressive B-NHL

NCT04152577 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2019-11-05

No results posted yet for this study

Summary

In this study，lenalidomide was added in the first-line treatment in the newly diagnosed highly invasively non-Hodgkin B-cell lymphoma. The R2-CHOP/R2-EPOCH etc was applied compared with the classical R-CHOP/R-EPOCH etc. The investigators tried to explore a more effective and safe treatment regimen for patients with high-risk B-cell lymphoma to improve the patient's poor prognosis.

Conditions

  • Lymphoma, B-Cell

Interventions

DRUG

R2-combination chemotherapy

R2-CHOP/CHOPE/DA-EPOCH/HD MTX R2-CHOP : lenalidomide 25mg/d po D1-10; Rituximab：375mg/m2，ivgtt，D0 Cyclophosphamide 750mg / m2 d1, doxorubicin 70mg / m2 or Doxorubicin liposome 30-40 mg / m2 d2, vincristine 1.4mg / m2 or vindesine 3mg / m2 d2, prednisone 100mg d1-5 R2-DA-EPOCH: lenalidomide 25mg/d po D1-10; Rituximab：375mg/m2，ivgtt，D0 Epirubicin 15mg／m２ ,d1-4; Etoposide 50mg／m２ ,d1-4; Vincristine 0.4mg/ ｍ２ ，d1-4; Cyclophosphamide 750mg/ ｍ２ , d５; Prednisone 60mg/m２/d, d1-5; R2-HD MTX: lenalidomide 25mg/d po D1-10; Rituximab：375mg/m2，ivgtt，D0； MTX 3.5g／ｍ２,ｄ1

DRUG

R-combination chemotherapy

R-CHOP/CHOPE/DA-EPOCH/HD MTX R-CHOP : Rituximab：375mg/m2，ivgtt，D0 Cyclophosphamide 750mg / m2 d1, doxorubicin 70mg / m2 or Doxorubicin liposome 30-40 mg / m2 d2, vincristine 1.4mg / m2 or vindesine 3mg / m2 d2, prednisone 100mg d1-5 R-DA-EPOCH: Rituximab：375mg/m2，ivgtt，D0 Epirubicin 15mg／m２ ,d1-4; Etoposide 50mg／m２ ,d1-4; Vincristine 0.4mg/ ｍ２ ，d1-4; Cyclophosphamide 750mg/ ｍ２ , d５; Prednisone 60mg/m２/d, d1-5; R-HD MTX: Rituximab：375mg/m2，ivgtt，D0； MTX 3.5g／ｍ２,ｄ1

Sponsors & Collaborators

  • Shandong Provincial Hospital

    lead OTHER_GOV

Principal Investigators

  • Xin Wang, MD,PhD · Shandong Provincial Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-05
Primary Completion
2021-10-01
Completion
2022-01-01

Countries

  • China

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04152577 on ClinicalTrials.gov