Lenalidomide Combined With R-CHOP(R2-CHOP) in Newly Diagnosed Double-expressor Diffuse Large B-Cell Lymphoma Patients

November 14, 2019 updated by: Junning Cao, MD, Fudan University

Lenalidomide Combined With R-CHOP in Newly Diagnosed Double-expressor Diffuse Large B-Cell Lymphoma Patients

In this phase II study, the investigators are aiming to explore lenalidomide combined with R-CHOP (R2-CHOP) in newly diagnosed double-expressor Diffuse Large B-Cell Lymphoma patients (DLBCL)

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Double expressor lymphoma is a subtype of diffuse large B-cell lymphoma defined as having increased expression of MYC and BCL-2 by immunohistochemistry. Patients with double-expressor lymphomas have a poor prognosis when treated with standard chemoimmunotherapy and have increased risk of progression and recurrence. The investigators conducted this study to evaluate the efficacy of lenalidomide combined with R-CHOP (R2-CHOP) in newly diagnosed double-expressor, untreated Diffuse Large B-Cell Lymphoma patients (DLBCL). Lenalidomide is the second-generation immunomodulatory drug, and its anti-tumor mechanism may involve immunomodulatory, antiinflammatory, and antiangiogenic effects and suppression of tumor necrosis factor-alpha (TNF-α) from peripheral blood mononuclear cells. In this phase II study, the investigators are aiming to explore lenalidomide combined with R-CHOP (R2-CHOP) in newly diagnosed double-expressor Diffuse Large B-Cell Lymphoma patients (DLBCL), in order to find a potential promising way to treat this kind of disease.

Study Type

Interventional

Enrollment (Anticipated)

62

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

Study Locations

  • China
      • Shanghai, China, 200032
        • Recruiting
        • 270 Dongan Road, Fudan University Shanghai Cancer Center
        • Contact:

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 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age range 18-75 years old
  2. Eastern Cooperative Oncology Group performance status 0 to 2;
  3. Newly diagnosed, untreated, histological confirmed diffuse large B cell lymphoma, and Myc≥40% as well as Bcl-2≥50% through immunohistochemistry；
  4. Measurable disease was defined as at least one lesion ≥1.5 cm in length-diameter and ≥1.0cm in short-diameter by CT or MRI.
  5. White blood cell ≥ 3.5×109/L, absolute neutrophil count ≥ 1.5×109/L，platelet ≥ 80×109/L，hemoglobin ≥ 90 g/L. If abnormal factors of peripheral blood caused by bone marrow or spleen involvement of lymphoma, whether to enroll depends on the judgment of researchers
  6. Total bilirubin < 1.5×upper limit of normal(ULN), ALT and AST < 1.5× ULN
  7. serum creatine <1.5×ULN, and creatinine clearance rate (CCR) ≥ 40 ml/min
  8. Ultrasonic cardiogram or nuclide cardiac function showed left ventricle ejection fraction ≥ 50%
  9. Women of childbearing potential and men who are sexually active are consent to practicing a highly effective method of birth control. Women of childbearing potential must have a negative serum β-hCG within 2 weeks of enrollment
  10. Patients have written informed consent to participate in the study.

Exclusion Criteria:

  1. Prior sever allergy to humanized or mouse derived monoclonal antibody. Unable to receive either lenalidomide or R-CHOP background chemotherapy.
  2. History of myocardial diseases, such as unstable angina pectoris, acute myocardial infarction within 6 months of enrollment, congenital heart failure NYHA III/IV
  3. Particular kind of DLBCL，such as primary mediastinal/thymic B-cell lymphoma, EBV positive DLBCL, primary cutaneous large B lymphoma, leg type.
  4. Presence of CNS involvement
  5. Having surgeries ≥ grade 2 within 3 weeks of enrollment.
  6. History or now in the treatment process of other malignancies except cured basal cell carcinoma of skin (melanoma not included), and carcinoma in-situ of uterine cervix.
  7. More than grade 3 neurotoxicity within 2 two weeks of enrollment
  8. Receiving any treatment for lymphoma except short use of corticosteroid (no more than 10 days)
  9. History of deep vein thrombosis or pulmonary embolism within 12 months of enrollment
  10. Unable or reject to receive antithrombotic treatment
  11. Presence of active HBV infection (HBsAg positive and HBV-DNA≥ 104), HCV infection, acquired and congenital immunodeficiency diseases include but not limited to HIV
  12. Pregnant or lactating women
  13. Previously received organ transplant
  14. Serious uncontrolled infection
  15. Having contraindications to the use of large doses of hormone, such as uncontrolled hyperglycemia, gastric ulcer, mental disorder.
  16. Severe neurol of mental illness, including dementia and epilepsy.
  17. Drug abuse, medical, psychological or social conditions which may interfering with subjects' participation in the study or evaluation of the results
  18. Patients considered unsuitable to participate in the study by the researchers

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: R2-CHOP
Lenalidomide combined with rituximab, cyclophosphamide, vincristine, doxorubicin, prednisone
Drug: Lenalidomide combined with R-CHOP
rituximab 375 mg/m2,ivgtt D1 cyclophosphamide 750 mg/m2 iv D2 vincristine 1.4 mg/m2 [capped at 2.0 mg], iv D2 doxorubicin 50 mg/m2 iv D2 prednisone 100 mg/m2 per day PO D2-6 Lenalidomide 25mg PO QD D2-11
Other Names:
  • R2-CHOP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
2-year progression free survival
Time Frame: From date of patients sign informed consent until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years
the period from the date of patients sign informed consent to the observed progression of the disease or the occurrence of death for any reason
From date of patients sign informed consent until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
objective response rate
Time Frame: at the end of Cycle 6 (each cycle is 21 days)
the ratio of numbers of patients with complete response and partial response to all the participants receiving treatment
at the end of Cycle 6 (each cycle is 21 days)
overall survival
Time Frame: From date of patients sign informed consent until the date of death or the date of last follow-up time, whichever came first, assessed up to 2 years
time between the date of patients sign informed consent and the date of death or the date of last follow-up time
From date of patients sign informed consent until the date of death or the date of last follow-up time, whichever came first, assessed up to 2 years
Hematology and non hematology toxicity
Time Frame: Throughout the treatment period，up to 6 months
number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Throughout the treatment period，up to 6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
serum cfDNA biomarkers and tissue biomarkers
Time Frame: up to 2 years
detection of serum and tissue biomarkers in the treatment of double-expressor lymphoma
up to 2 years

Collaborators and Investigators

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

Sponsor

Fudan University

Investigators

  • Principal Investigator: Junning Cao, Fudan University

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)

October 22, 2019

Primary Completion (Anticipated)

October 1, 2021

Study Completion (Anticipated)

October 1, 2021

Study Registration Dates

First Submitted

October 23, 2019

First Submitted That Met QC Criteria

November 14, 2019

First Posted (Actual)

November 15, 2019

Study Record Updates

Last Update Posted (Actual)

November 15, 2019

Last Update Submitted That Met QC Criteria

November 14, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DE-LYM2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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