R2-CHOP in Untreated DEL-DLBCL：An Open-lable，Multicenter，Phase II Study

April 12, 2021 updated by: Li Zhiming, Sun Yat-sen University

Lenalidomide Combined With Anti-CD20 Monoclonal Antibodies-CHOP in Untreated Diffuse Large B-Cell Lymphoma Patients With MYC and BCL2 Co-expression : An Open-lable，Multicenter，Phase II Study

To assess the efficacy and safety of lenalidomide combined with rituximab, vincristine, doxorubicin, cyclophosphamide, and prednisone (r2-chop) in the initial treatment of DEL-DLBCL. The primary endpoint is the complete response rate, and the second endpoints are survival time (OS and PFS) and overall response rate.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with MYC and BCL2 co-expression Diffuse Large B-Cell Lymphoma diagnosed by histopathologyImmunohistochemistry confirmed that the positive expression rate of BCL-2≥50% and c-Myc≥ 40%.
  • Male or female patients: 18-80 years old.
  • ECOG physical condition score: 0-2 points for patients.
  • IPI score≥3.
  • Patients have not received any anti-tumor therapy such as radiotherapy, chemotherapy, targeted therapy or stem cell transplantation.
  • In those patients with at least one evaluable or measurable lesion meeting Lugano 2014 criteria, the evaluable lesion was: 18F fluorodeoxyglucose / positron emission tomography (18FDG / PET) examination showed that the uptake of lymph nodes or extranodal areas was increased (higher than that of liver) and pet and / or computed The features of tomography (CT) were in accordance with lymphoma. The measurable lesions were nodal lesions with a length of > 15 mm or extranodal lesions with a length of > 10 mm, accompanied by an increase in 18FDG uptake. There was no measurable lesion and the uptake of 18FDG was increased.
  • Patients with good function of main organs, i.e. one week before admission, met the following requirements: WBC >= 3.5×10^9 / L, NEU≥1.5×10^9/L, Hb >= 80g / L, PLT >= 100 ×10^9 / L; heart and liver functions were normal (total bilirubin <= 1.5 times of normal value, ALT and AST <= 2.5 times of normal value), renal functions were normal (serum creatinine <= 1.5 times of normal value), and coagulation function was not abnormal.
  • LVEF≥50%, measured by echocardiography.
  • No other tumor-specific concomitant therapy has been administered (including steroids).
  • Pregnant women of childbearing age must have a pregnancy test (serum or urine) within 14 days before enrollment and the result is negative, and they are willing to use reliable methods of contraception during the test.
  • Patients have no other serious diseases in conflict with this clinical trial protocols.
  • The subjects who volunteer to join the study and sign the informed consent form, have good compliance and cooperate with the follow-up.

Exclusion Criteria:

  • Other types of DLBCL: Diffuse large B-cell lymphoma associated with chronic inflammation, lymphomatoid granulomatosis, Primary mediastinal (thymic) large B-cell lymphoma, ALK-positive large B-cell lymphoma, Primary effusion lymphoma, Burkitt lymphoma, High-grade B-cell lymphoma(including High-grade B-cell lymphoma, NOS, High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements), B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and classic Hodgkin lymphoma, Primary diffuse large B-cell lymphoma of the CNS, EBV-positive diffuse large B-cell lymphoma.
  • Transformed DLBCL (transformed DLBCL from follicular lymphoma, chronic lymphocytic leukemia/small B lymphocytic lymphoma), Diffuse large B-cell lymphoma with secondary involvement of the central nervous system (SCNS-DLBCL).
  • Other malignancies within the past 5 years except for carcinoma of the cervix or basal or squamous cell carcinomas of the skin.
  • Major surgical procedures (excluding diagnostic surgical procedures) performed in the past 2 months.
  • Prior treatment for NHL, concomitant chemotherapy, radiotherapy immunotherapy, monoclonal antibody therapy, surgical treatment (except for diagnostic surgery and biopsy).
  • Prior treatment with cytotoxic drugs or anti-CD20 monoclonal antibody for other conditions (e.g. Rheumatoid arthritis)
  • Prior treatment with thalidomide, lenalidomide, or other drugs.
  • Prior treatment with any monoclonal antibody within the preceding 3 months. Prior treatment with live (attenuated) virus vaccine within the preceding 1 month.
  • Patients taking hematopoietic cytokines within 2 weeks before enrollment.
  • Patients with suspected active or latent TB infections.
  • Patients with known active bacterial, viral, fungal, mycobacterium, parasitic or other infections (excluding fungal nail infection) or any serious systemic infections requiring intravenous antibiotic treatment or hospitalization (excluding neoplastic fever) in the 4 weeks prior to enrollment.
  • Other serious conditions that may limit patients participation in the trial, such as Uncontrolled diabetes, Severe cardiac insufficiency (NYHA grade II or above), Acute coronary syndrome in the last 6 months, Coronary revascularization includes stent implantation, coronary artery bypass surgery, and other cardiac and vascular related procedures in the last 6 months, severe arrhythmia (including frequent ventricular premature beats, ventricular tachycardia , fast atrial fibrillation/ atrial flutter, severe bradycardia), Uncontrolled high blood pressure(>150/100mmHg), gastric ulcer(gastric ulcers were at risk of perforation), Active autoimmune disease, Severe hypertension, Severe respiratory disease(obstructive pulmonary disease or history of bronchospasm).
  • Any contraindication of the CHOP drugs, including previously received anthracycline antibiotics; Patients with diabetes cannot tolerate prednisone therapy.
  • Patients had a history of alcohol abuse or drug abuse.
  • Allergic physique or known sensitivity or allergy to the active ingredient, excipient, murine products, heterologous proteins of any drug used in this treatment(including CHOP).
  • Patients with serious mental illness.
  • Patients who are unable to comply during the trial and/or follow-up phase.
  • The researchers considered the patients unsuitable for the study.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment arm
  1. Lenalidomide：25mg po QN,D1-10
  2. Rituximab: 375mg/m2, ivdrip, D1
  3. CTX: 750mg/m2, iv or ivdrip, D1
  4. THP: 50mg/m2, iv or ivdrip, D1
  5. VCR： 1.4 mg/m2 , iv（max：2mg）, D1
  6. Pred: 60mg/m2, po, D1-5
Drug: R2-CHOP(Lenalidomide,Rituximab,cyclophosphamide，hydroxyldaunorubicin，Vincristine，Prednisone）)
Lenalidomide：25mg po QN,d1-10 Rituximab: 375mg/m2, ivdrip, d1 Cyclophosphamide: 750mg/m2, iv or ivdrip, d1 Hydroxyldaunorubicin: 50mg/m2, iv or ivdrip, d1 Vincristine： 1.4 mg/m2 , iv（max：2mg）, d1 Prednisone: 60mg/m2, po, d1-5 every 3 weeks was a course of treatment

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Complete response rate
Time Frame: Up to 3 years
The complete response rate
Up to 3 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Progression-free survival
Time Frame: Up to 3 years
PFS was defined as time from study registration to first disease progression or death whichever occurred first, otherwise subject data were censored at time last known disease free.
Up to 3 years
Overall Survival
Time Frame: Up to three years
OS was defined as time from study registration to death, and otherwise censored at time last known alive.
Up to three years
Objective Remission Rate
Time Frame: Up to 2 years
CR+PR
Up to 2 years

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sun Yat-sen 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 (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 10, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 8, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 13, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 13, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • B2020-052-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

YES

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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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

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