NCT04152577

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2019

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

June 5, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 27, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 5, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

November 5, 2019

Status Verified

November 1, 2019

Enrollment Period

2.3 years

First QC Date

October 27, 2019

Last Update Submit

November 4, 2019

Conditions

Lymphoma, B-Cell

Keywords

Lenalidomide，rituximab，chemotherapy，highly aggressive B-NHL

Outcome Measures

Primary Outcomes (2)

  • Overall Response Rate after 3 cycles

    Percentage of patients with complete remission （CR）or partial remission （PR）

    at the end of 3 cycles( each cycle is 21 days)

  • Overall Response Rate after 6 cycles

    Percentage of patients with complete remission （CR）or partial remission （PR）

    at the end of 6 cycles( each cycle is 21 days)

Secondary Outcomes (2)

  • Progression free survival（PFS）

    2 years

  • overall survival（OS）

    2 years

Study Arms (2)

R2-combination chemotherapy

EXPERIMENTAL

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: R2-combination chemotherapy

R-combination chemotherapy

ACTIVE COMPARATOR

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

Drug: R-combination chemotherapy

Interventions

R2-combination chemotherapyDRUG

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

R2-combination chemotherapy
R-combination chemotherapyDRUG

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

R-combination chemotherapy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Newly diagnosed highly aggressively B-Cell Non-Hodgkin's lymphoma (NHL) confirmed by histopathology
  • The patient has at least ≥1 measurable tumor lesion with a diameter \>1.5 cm;
  • The patient has not undergone systemic chemotherapy or immunotherapy before;
  • ECOG score ≤ 2 points;
  • Liver and kidney function meets the following conditions: creatinine clearance rate ≥ 30ml / min, total bilirubin, AST and ALT ≤ 2.5 × ULN;
  • No history of malignant tumors within 5 years, except for cured carcinomas in situ such as basal cell carcinoma of the skin, cervical cancer, breast cancer, prostate cancer, etc.;
  • agree to take contraceptive measures during the trial period and within 3 months after the end of the trial;
  • Patients volunteered to participate in the study and signed informed consent.

You may not qualify if:

  • Serious cardiovascular and other important organs and blood, endocrine system lesions, and other history of malignant tumors;
  • Severe mental illness;
  • Pregnant or lactating women and men or women who intend to conceive in the near future;
  • The expected survival time is less than 6 months;
  • HBV, HCV or HIV infection or seropositive;
  • there are active infections;
  • Allergies or allergies to rituximab;
  • Compliance or poor follow-up;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Hematology, Provincial Hospital Affiliated to Shandong University

Jin'an, Shandong, 250012, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, B-Cell

Condition Hierarchy (Ancestors)

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

Study Officials

  • Xin Wang, MD,PhD

    Shandong Provincial Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xin Wang, MD,PhD

CONTACT

+86-531-68778331xinw8331@163.com

Xiao Lv, MD,PhD

CONTACT

+86-531-68778331lvxiao8377@sina.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Hematology Department

Study Record Dates

First Submitted

October 27, 2019

First Posted

November 5, 2019

Study Start

June 5, 2019

Primary Completion

October 1, 2021

Study Completion

January 1, 2022

Last Updated

November 5, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)