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

November 29, 2023 updated by: Yanyan Liu, Henan Cancer Hospital

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2

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

  • Name: Yanyan Liu, M.D. Ph.D
  • Phone Number: +8613818176375
  • Email: yyliu@zzu.edu.cn

Study Locations

  • China
    • Henan
      • Zhengzhou, Henan, China
        • Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university

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

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 or aaIPI score 2-3/ Immunohistochemical staining of double expression (BCL2 ≥ 50% 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) 0-2
  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

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: R-CHOP regimen Combined With Lenalidomide

Experimental: R-CHOP regimen Combined With Lenalidomide Induction 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.

Patients will exit and receive salvage treatment for the following situations: disease progression, stable disease after 2 cycles treatment, partial response after 4 cycles treatment or unacceptable toxicity develops.

Maintenance Treatment for patients with CR after 6 cycles: Rituximab, 375mg/m2, Intravenous administration on day 0 repeated every 3 weeks until disease progression or unacceptable toxicity develops, up to 2 cycles.

PS: Methotrexate, 1g/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.
Drug: Vincristine
Induction Chemotherapy: 1.4mg/m2 (Max: 2mg), Intravenous administration on day 1 of each 3-week cycle until disease progression/stable disease after 2 cycles treatment, partial response after 4 cycles treatment or unacceptable toxicity develops, up to 6 cycles.
Other Names:
  • Vincristine Injection
Drug: Prednisone
Induction Chemotherapy: 100mg, oral administration on day 1 to 5 of each 3-week cycle until disease progression/stable disease after 2 cycles treatment, partial response after 4 cycles treatment or unacceptable toxicity develops, up to 6 cycles.
Other Names:
  • Prednisone Oral Product
Drug: Rituximab

Induction Chemotherapy: 375mg/m2, Intravenous administration on day 0 of each 3-week cycle until disease progression, stable disease after 2 cycles treatment, partial response after 4 cycles treatment or unacceptable toxicity develops, up to 6 cycles.

Maintenance Treatment for patients with CR after 6 cycles: Rituximab, 375mg/m2, Intravenous administration on day 0 repeated every 3 weeks until disease progression or unacceptable toxicity develops, up to 2 cycles (Total 8 cycles).

Other Names:
  • RiTUXimab Injection
Drug: Lenalidomide
Induction Chemotherapy: 25mg, oral administration on day 1 to 10 of each 3-week cycle until disease progression, stable disease after 2 cycles treatment, partial response after 4 cycles treatment or unacceptable toxicity develops, up to 6 cycles.
Other Names:
  • Lenalidomide capsule
Drug: Cyclophosphamide
Induction Chemotherapy: 750mg/m2, Intravenous administration on day 1 of each 3-week cycle until disease progression, stable disease after 2 cycles treatment, partial response after 4 cycles treatment or unacceptable toxicity develops, up to 6 cycles.
Other Names:
  • Cyclophosphamide Injection
Drug: Epirubicin
Induction Chemotherapy: 70mg/m2, Intravenous administration on day 1 of each 3-week cycle until disease progression, stable disease after 2 cycles treatment, partial response after 4 cycles treatment or unacceptable toxicity develops, up to 6 cycles.
Other Names:
  • Epirubicin hydrochloride
Drug: Methotrexate
Induction Chemotherapy: 1g/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.
Other Names:
  • Methotrexate Injectable Solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
exploratory endpoint
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
The correlation between hotspot driven gene mutations and complete response rate, PFS, or OS
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

Collaborators and Investigators

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

Sponsor

Henan Cancer Hospital

Investigators

  • Study Director: Yanyan Liu, M.D. Ph.D, Henan Cancer Hospital

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 2, 2020

Primary Completion (Actual)

November 29, 2023

Study Completion (Estimated)

January 2, 2025

Study Registration Dates

First Submitted

December 26, 2019

First Submitted That Met QC Criteria

December 27, 2019

First Posted (Actual)

January 2, 2020

Study Record Updates

Last Update Posted (Estimated)

December 5, 2023

Last Update Submitted That Met QC Criteria

November 29, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HNSZLYYNHL02

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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