NCT02428751|UnknownPhase 3

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

Rituximab, Cyclophosphamide, Vincristine, and Prednisone in Combination With Doxorubicin (R-CHOP) Versus in Combination With Pegylated-liposomal Doxorubicin (R-CDOP) as First-line Treatment for Elderly Patients With Diffuse Large-B-cell Lymphoma: a Randomised, Multicentre, Non-inferiority Study

Wenqi Jiang ClinicalTrials.gov

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1 other identifier

308-2015-005

Study Type

interventional

Target

216

Locations

1 country

Sites

Timeline

RegisteredApr 2015

StartedSep 2015

CompletionMay 2020

Brief Summary

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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

216

participants targeted

Target at P25-P50 for phase_3

Timeline

Completed

Started Sep 2015

Longer than P75 for phase_3

Geographic Reach

1 country

7 active sites

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4.7 years study duration

First Submitted

Initial submission to the registry

April 17, 2015

Completed

12 days until next milestone

First Posted

Study publicly available on registry

April 29, 2015

Completed

4 months until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed

4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed

Last Updated

November 18, 2015

Status Verified

November 1, 2015

Enrollment Period

4.5 years

First QC Date

April 17, 2015

Last Update Submit

November 17, 2015

Conditions

Lymphoma, Large B-Cell, Diffuse

Keywords

Lymphoma, Large B-Cell, Diffuseliposomal doxorubicindoxorubicinevent-free survival

Outcome Measures

Primary Outcomes (1)

event-free survival (EFS)
Defined as time from the date of randomization to the date of disease progression, death due to any cause, termination of treatment, or the most recent follow-up
two year

Secondary Outcomes (3)

overall response rate (ORR)
at week 6, 12, 18, and 24 after randomization
complete remission (CR) rate
at week 6, 12, 18, and 24 after randomization
overall survival (OS)
two year

Study Arms (2)

R-CHOP

ACTIVE COMPARATOR

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.

Drug: DoxorubicinDrug: RituximabDrug: CyclophophamideDrug: VincristineDrug: Prednisone

R-CDOP

EXPERIMENTAL

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.

Drug: Pegylated liposomal doxorubicinDrug: RituximabDrug: CyclophophamideDrug: VincristineDrug: Prednisone

Interventions

Pegylated liposomal doxorubicinDRUG

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

R-CDOP

DoxorubicinDRUG

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

R-CHOP

RituximabDRUG

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

R-CDOPR-CHOP

CyclophophamideDRUG

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

R-CDOPR-CHOP

VincristineDRUG

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

R-CDOPR-CHOP

PrednisoneDRUG

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

R-CDOPR-CHOP

Eligibility Criteria

Age60 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Pathologically confirmed diagnosis of CD20-positive diffuse large B-cell lymphoma
\~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

You may not qualify if:

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

Contact the study team to confirm eligibility.