Clinical Trials /

R-CHOP Combined With Lenalidomide in the First-line Treatment for Patients With Diffuse Large B Cell Lymphoma

NCT04214626

Description:

This is a prospective single arm, multi-center, phase II clinical trial to observe the efficacy and safety of R-CHOP (Rituximab-Cyclophosphamide, Epirubicin, Vincristine and Prednisone) combined with lenalidomide in the first-line treatment for patients with medium to high risk/high risk diffuse large B cell lymphoma.

Related Conditions:
  • Diffuse Large B-Cell Lymphoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: R-CHOP Combined With Lenalidomide in the First-line Treatment for Patients With Diffuse Large B Cell Lymphoma
  • Official Title: A Single Arm, Multi-center, Phase II Clinical Trial of R-CHOP Combined With Lenalidomide in the First-line Treatment for Patients With Medium to High Risk/High Risk Diffuse Large B Cell Lymphoma

Clinical Trial IDs

  • ORG STUDY ID: HNSZLYYNHL02
  • NCT ID: NCT04214626

Conditions

  • Diffuse Large B Cell Lymphoma

Interventions

DrugSynonymsArms
RituximabRiTUXimab InjectionR-CHOP regimen Combined With Lenalidomide
LenalidomideLenalidomide capsuleR-CHOP regimen Combined With Lenalidomide
CyclophosphamideCyclophosphamide InjectionR-CHOP regimen Combined With Lenalidomide
EpirubicinEpirubicin hydrochlorideR-CHOP regimen Combined With Lenalidomide
VincristineVincristine InjectionR-CHOP regimen Combined With Lenalidomide
PrednisonePrednisone Oral ProductR-CHOP regimen Combined With Lenalidomide
MethotrexateMethotrexate Injectable SolutionR-CHOP regimen Combined With Lenalidomide

Purpose

This is a prospective single arm, multi-center, phase II clinical trial to observe the efficacy and safety of R-CHOP (Rituximab-Cyclophosphamide, Epirubicin, Vincristine and Prednisone) combined with lenalidomide in the first-line treatment for patients with medium to high risk/high risk diffuse large B cell lymphoma.

Detailed Description

      Diffuse large B cell lymphoma (DLBCL) is the most common type of non-Hodgkin's lymphoma
      (NHL). Currently, R-CHOP is world-widely used in the first-line treatment for DLBCL. There
      are about one second of patients suffering relapse and drug resistance. Lenalidomide is an
      analog of thalidomide, the mechanism of anti-tumor action has not been fully elucidated.
      Lenalidomide has been proved to inhibit the proliferation of tumor cells in certain
      hematopoietic systems. At present, it has been approved for the treatment of multiple myeloma
      with good efficacy and safety. The goal of our trial is to assess the efficacy and safety of
      R-CHOP combined with lenalidomide in the first-line treatment for patients with medium to
      high risk/high risk diffuse large B cell lymphoma.
    

Trial Arms

NameTypeDescriptionInterventions
R-CHOP regimen Combined With LenalidomideExperimentalInduction Chemotherapy: Rituximab, 375mg/m2, Intravenous administration on day 0, Lenalidomide, 25mg oral administration on day 1 to 10, combined with regimen:CHOP (Cyclophosphamide, Epirubicin, Vincristine and Prednisone): repeated every 3 weeks, up to 6 cycles. PS: Methotrexate, 3mg/m2, Intravenous administration on day 3 of each 3-week cycle, from 2 to 5 cycles for patients with high recurrence risk of the central nervous system. Maintenance Treatment: Rituximab, 375mg/m2, Intravenous administration on day 0 repeated every 4 weeks, up to 2 cycles; Lenalidomide, 10mg oral administration on day 1 to 21 repeated every 4 weeks, up to 12 cycles.
  • Rituximab
  • Lenalidomide
  • Cyclophosphamide
  • Epirubicin
  • Vincristine
  • Prednisone
  • Methotrexate

Eligibility Criteria

        Inclusion Criteria:

          1. Age between 18 to 70 years old (including 18 and 70)

          2. Diagnosed as diffuse large B cell lymphoma

          3. Subjects must be untreated (medium to high risk/high risk: International Prognostic
             Index (IPI) score 3-5, aaIPI score 2-3 or NCCN-IPI score≥ 4/ Immunohistochemical
             staining of double expression (BCL2 ≥ 70% and C-MYC ≥ 40%) or P53 protein mutation
             positive ≥ 50%)

          4. No receiving chemotherapy before enrollment

          5. Having at least one measurable lesions

          6. World health organization-Eastern Cooperative Oncology Group Performance Status (ECOG)
             0-1

          7. Life expectancy no less than 3 months

          8. enough main organ function

          9. Pregnancy test within 7 days must be negative for women of childbearing period, and
             appropriate measures should be taken for contraception for women in childbearing
             period during the study and six months after this study

         10. Agreeing to sign the written informed consents

        Exclusion Criteria:

          1. Diagnosed as high-grade B-cell lymphoma, including non-specified and double-strike or
             triple-strike

          2. Diagnosed as grey-zone lymphoma

          3. Diagnosed as central nervous system lymphoma

          4. Diagnosed as primary mediastinal large B-cell lymphoma

          5. Diagnosed as CD20 negative diffuse large B-cell lymphoma

          6. Other malignant tumor history or active malignant tumor need be treated

          7. Serious surgery and trauma less than two weeks

          8. Systemic therapy for serious acute/chronic infection

          9. Congestive heart failure, uncontrolled coronary heart disease, arrhythmia and heart
             infarction less than 6 months

         10. Vaccination with live attenuated vaccine less than 4 weeks

         11. HIV-positive, AIDS patients and untreated active hepatitis

         12. Patients with a history of deep vein thrombosis or pulmonary embolism less than 12
             months

         13. Patients with a history of mental illness

         14. Researchers determine unsuited to participate in this trial
      
Maximum Eligible Age:70 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:2-year progression-free survival
Time Frame:from the day of the first cycle of treatment to the date of confirmed progressive disease or death, whichever occurs first, up to 2 years after last patient's enrollment
Safety Issue:
Description:the total proportion of patients with no progression from date of the first day of treatment to the date of confirmed progressive disease or death which one occurs first

Secondary Outcome Measures

Measure:objective response rate
Time Frame:every 6 weeks from the day of the first cycle of induction chemotherapy treatment and every 8 weeks from the day of the first cycle of maintenance treatment to 18 months after last patient's enrollment
Safety Issue:
Description:the total proportion of patients with complete response (CR) and partial response (PR)
Measure:2-year overall survival
Time Frame:from date of the first cycle of treatment to the date of death from any cause, assessed up to 2 years
Safety Issue:
Description:from date of first day of treatment to the date of death by any cause
Measure:incidence and relationship with study drugs of grade 3-4 adverse events
Time Frame:from the date of the first cycle of treatment to 18 months after last patient's enrollment
Safety Issue:
Description:the incidence and relationship with study drugs of grade 3 or 4 adverse events (based on NCI CTC-AE v4.03)

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Henan Cancer Hospital

Trial Keywords

  • Diffuse Large B Cell Lymphoma
  • R-CHOP
  • Lenalidomide

Last Updated

December 31, 2019