R-CHOP Versus R-CDOP as First-line Treatment for Elderly Patients With Diffuse Large-B-cell Lymphoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

216 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2020-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The combination of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP regimen) has been the first-line chemotherapy for elderly patients with diffuse large B-cell lymphoma (DLBCL). The treatment-related toxicities, especially the severe cardiac toxicities induced by anthracycline drugs (doxorubicin), have become a major concern among elderly patients. Pegylated liposomal doxorubicin is a formulation of doxorubicin with a prolonged circulation time and unique toxicity profile. Previous single arm studies of elderly patients with lymphoma used pegylated liposomal doxorubicin instead of traditional doxorubicin in combination with rituximab, cyclophosphamide, vincristine, and prednisone (the novel R-CDOP regimen), and demonstrated better safety profile, including less bone marrow suppression and less cardiac toxicities, while maintaining the efficacy. However, the efficacy and safety of these two regimens (R-CHOP and R-CDOP) have not been head-to-head compared in a randomized study. The aim of this study is to compare the efficacy and safety of R-CDOP (rituximab, cyclophosphamide, pegylated liposomal doxorubicin, vincristine, and prednisone) and R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) in previously untreated elderly patients with DLBCL.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lymphoma, Large B-Cell, Diffuse

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

R-CHOP

This group received R-CHOP regimen as the first-line chemotherapy. Rituximab, 375mg/m2, iv, d0; Cyclophophamide, 750mg/m2, iv, d1; Doxorubicin, 50mg/m2, iv, d1; Vincristine, 2mg/m2 (max 2mg), iv, d1; Prednisone, 100mg, po, d1-5. Repeat every 21 days for 6-8 cycles or until the criteria of terminating treatment was met.

Group Type ACTIVE_COMPARATOR

Doxorubicin

Intervention Type DRUG

50 mg/m2, IV (in the vein) on day 1 of each 21 day cycle

Rituximab

Intervention Type DRUG

375 mg/m2, IV (in the vein) on day 0 of each 21 day cycle

Cyclophophamide

Intervention Type DRUG

750 mg/m2, IV (in the vein) on day 1 of each 21 day cycle

Vincristine

Intervention Type DRUG

1.4 mg/m2 (2mg in maxium), IV (in the vein) on day 1 of each 21 day cycle

Prednisone

Intervention Type DRUG

100mg/d, PO on day 1-5 of each 21 day cycle

R-CDOP

This group received R-CDOP regimen as the first-line chemotherapy. Rituximab, 375mg/m2, iv, d0; Cyclophophamide, 750mg/m2, iv, d1; Pegylated liposomal doxorubicin, 30mg/m2, iv, d1; Vincristine, 2mg/m2 (max 2mg), iv, d1; Prednisone, 100mg, po, d1-5. Repeat every 21 days for 6-8 cycles or until the criteria of terminating treatment was met.

Group Type EXPERIMENTAL

Pegylated liposomal doxorubicin

Intervention Type DRUG

30 mg/m2, IV (in the vein) on day 1 of each 21 day cycle

Rituximab

Intervention Type DRUG

375 mg/m2, IV (in the vein) on day 0 of each 21 day cycle

Cyclophophamide

Intervention Type DRUG

750 mg/m2, IV (in the vein) on day 1 of each 21 day cycle

Vincristine

Intervention Type DRUG

1.4 mg/m2 (2mg in maxium), IV (in the vein) on day 1 of each 21 day cycle

Prednisone

Intervention Type DRUG

100mg/d, PO on day 1-5 of each 21 day cycle

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Pegylated liposomal doxorubicin

30 mg/m2, IV (in the vein) on day 1 of each 21 day cycle

Intervention Type DRUG

Doxorubicin

50 mg/m2, IV (in the vein) on day 1 of each 21 day cycle

Intervention Type DRUG

Rituximab

375 mg/m2, IV (in the vein) on day 0 of each 21 day cycle

Intervention Type DRUG

Cyclophophamide

750 mg/m2, IV (in the vein) on day 1 of each 21 day cycle

Intervention Type DRUG

Vincristine

1.4 mg/m2 (2mg in maxium), IV (in the vein) on day 1 of each 21 day cycle

Intervention Type DRUG

Prednisone

100mg/d, PO on day 1-5 of each 21 day cycle

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Pathologically confirmed diagnosis of CD20-positive diffuse large B-cell lymphoma
* 60\~80 years old
* Ann Arbor stage I\~IV
* ECOG physical score of 0\~2
* Have not received previous treatment to lymphoma, including chemotherapy, radiotherapy, or biotherapy
* Have at least one clinically measurable lesion: \>= 2cm under physical examination, or \>= 1.5cm under computed tomography (CT) or magnetic resonance (MR)
* Life expectancy of \>= 3 months
* Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamate pyruvate transaminase and total bilirubin \<= 2 × upper limit of normal (ULN)
* Glomerular filtration rate (MDRD method) \>= 30ml/min
* No abnormalities in blood coagulative function
* Generally normal bone marrow function: while blood cell \>= 3,000/μL, absolute neutrophil count \>= 1,500/μL, hemoglobin \>= 100g/L, platelet \>= 75,000/μL
* No evidence of active hepatitis B or C virus, or human immunodeficiency virus infection
* Left ventricular ejection fraction (LVEF) \>= 45% measured by two dimensional echocardiography or multi-gated acquisition (MUGA) scan
* Cardiac function of class I-II in New York Heart Association (NYHA) classification

Exclusion Criteria

* Patients with indolent lymphoma
* Positive results for in situ hybridization for Epstein-Barr virus encoded RNA (EBER)
* Serum Epstein-Barr virus DNA \>= 1,000 copies/ml
* Double-hit lymphoma confirmed by fluorescence in situ hybridization (FISH)
* Primary mediastinal B-cell lymphoma
* Involvement of central nervous system
* Bulky disease (\>= 10cm)
* History of cardiac disease, including clinically significant ventricular tachycardia, atrial fibrillation, conduction block, myocardial infarction within 1 year, congestive heart failure, symptomatic coronary heart disease which needs medication
* Known allergic reaction to any component of the agents used in the chemotherapeutic regimens that are used in the study
* Previous exposure to anthracycline drugs, rituximab, or chemotherapy for lymphoma
* History of malignant carcinoma within 5 years (except carcinoma in situ of the skin and uterine cervix, and prostatic carcinoma)
* Currently enrolled in other clinical studies
* Other conditions that the investigators consider as inappropriate for enrolling into this study

Minimum Eligible Age

60 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Wenqi Jiang

Chief of Department of Internal Medicine, Sun Yat-sen University Cancer Center

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Wen-qi Jiang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Site Status RECRUITING