Reduced Chemotherapy in Low Risk DLBCL

Phase 4

Active, not recruiting

• Conditions: Diffuse Large B-cell Lymphoma
• Interventions: Drug: Rituximab; Drug: Cyclophosphamide; Drug: Epirubicin; Drug: Vincristine; Drug: Prednisone

• Registration Number: NCT02752815
• Lead Sponsor: Ruijin Hospital

Brief Summary

This is a clinical trial to compare the efficacy and safety of four cycles of R-CHOP followed by four cycles of Rituximab with six cycles of R-CHOP followed by two cycles of Rituximab in the treatment of de novo, low-risk, non-bulky diffuse large B-cell lymphoma.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-04-20
• Study First Submitted QC: 2016-04-22
• Study First Posted: 2016-04-27
• Study Start: 2016-06-14
• Primary Completion: 2022-10-30
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-01
• Last Update Posted: 2022-12-05
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 290

Inclusion Criteria

• Histologically confirmed de novo diffuse large B-cell lymphoma, complete response after 4 cycles of standard R-CHOP21
• Age>=14 y.o.,<=75 y.o.
• IPI=0-1
• non-bulky (largest diameter <7.5cm)
• ECOG =0-1
• Life expectancy>6 months
• Informed consented

Exclusion Criteria

• Chemotherapy before
• Stem cell transplantation before
• History of malignancy, except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
• Uncontrollable cardio-cerebral vascular, coagulative, autoimmune, serious infectious disease
• Primary cutaneous, CNS DLBCL
• LVEF≤50%
• Other uncontrollable medical condition that may that may interfere the participation of the study
• Lab at enrollment(unless caused by lymphoma) Neutrophile<1.5*10^9/L Platelet<80*10^9/L Hemoglobulin<100g/L ALT or AST >2*ULN,AKP or bilirubin >1.5*ULN Creatinine>1.5*ULN
• Not able to comply to the protocol for mental or other unknown reasons
• Pregnant or lactation
• If HbsAg positive, should check HBV DNA, DNA positive patients cannot be enrolled. If HBsAg negative but HBcAb positive (whatever HBsAb status), should check HBV DNA,DNA positive patients cannot be enrolled.
• HIV infection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
6R-CHOP+2R	Cyclophosphamide	6 cycles of R-CHOP Rituximab 375 mg/m2 IV d1 Cyclophosphamide 750mg/m2 IV d2 Epirubicin 70mg/m2 IV d2 Vincristine 1.4 mg/m2 IV d2 Prednisone 60 mg/m2 PO d2-6 Frequency 21days 2 cycles of Rituximab monotherapy Rituximab 375 mg/m2 IV d1 Frequency 21days
6R-CHOP+2R	Epirubicin	6 cycles of R-CHOP Rituximab 375 mg/m2 IV d1 Cyclophosphamide 750mg/m2 IV d2 Epirubicin 70mg/m2 IV d2 Vincristine 1.4 mg/m2 IV d2 Prednisone 60 mg/m2 PO d2-6 Frequency 21days 2 cycles of Rituximab monotherapy Rituximab 375 mg/m2 IV d1 Frequency 21days
6R-CHOP+2R	Vincristine	6 cycles of R-CHOP Rituximab 375 mg/m2 IV d1 Cyclophosphamide 750mg/m2 IV d2 Epirubicin 70mg/m2 IV d2 Vincristine 1.4 mg/m2 IV d2 Prednisone 60 mg/m2 PO d2-6 Frequency 21days 2 cycles of Rituximab monotherapy Rituximab 375 mg/m2 IV d1 Frequency 21days
6R-CHOP+2R	Rituximab	6 cycles of R-CHOP Rituximab 375 mg/m2 IV d1 Cyclophosphamide 750mg/m2 IV d2 Epirubicin 70mg/m2 IV d2 Vincristine 1.4 mg/m2 IV d2 Prednisone 60 mg/m2 PO d2-6 Frequency 21days 2 cycles of Rituximab monotherapy Rituximab 375 mg/m2 IV d1 Frequency 21days
6R-CHOP+2R	Prednisone	6 cycles of R-CHOP Rituximab 375 mg/m2 IV d1 Cyclophosphamide 750mg/m2 IV d2 Epirubicin 70mg/m2 IV d2 Vincristine 1.4 mg/m2 IV d2 Prednisone 60 mg/m2 PO d2-6 Frequency 21days 2 cycles of Rituximab monotherapy Rituximab 375 mg/m2 IV d1 Frequency 21days
4R-CHOP+4R	Rituximab	4 cycles of R-CHOP Rituximab 375 mg/m2 IV d1 Cyclophosphamide 750mg/m2 IV d2 Epirubicin 70mg/m2 IV d2 Vincristine 1.4 mg/m2 IV d2 Prednisone 60 mg/m2 PO d2-6 Frequency 21days 2 cycles of Rituximab monotherapy Rituximab 375 mg/m2 IV d1 Frequency 21days
4R-CHOP+4R	Cyclophosphamide	4 cycles of R-CHOP Rituximab 375 mg/m2 IV d1 Cyclophosphamide 750mg/m2 IV d2 Epirubicin 70mg/m2 IV d2 Vincristine 1.4 mg/m2 IV d2 Prednisone 60 mg/m2 PO d2-6 Frequency 21days 2 cycles of Rituximab monotherapy Rituximab 375 mg/m2 IV d1 Frequency 21days
4R-CHOP+4R	Epirubicin	4 cycles of R-CHOP Rituximab 375 mg/m2 IV d1 Cyclophosphamide 750mg/m2 IV d2 Epirubicin 70mg/m2 IV d2 Vincristine 1.4 mg/m2 IV d2 Prednisone 60 mg/m2 PO d2-6 Frequency 21days 2 cycles of Rituximab monotherapy Rituximab 375 mg/m2 IV d1 Frequency 21days
4R-CHOP+4R	Vincristine	4 cycles of R-CHOP Rituximab 375 mg/m2 IV d1 Cyclophosphamide 750mg/m2 IV d2 Epirubicin 70mg/m2 IV d2 Vincristine 1.4 mg/m2 IV d2 Prednisone 60 mg/m2 PO d2-6 Frequency 21days 2 cycles of Rituximab monotherapy Rituximab 375 mg/m2 IV d1 Frequency 21days
4R-CHOP+4R	Prednisone	4 cycles of R-CHOP Rituximab 375 mg/m2 IV d1 Cyclophosphamide 750mg/m2 IV d2 Epirubicin 70mg/m2 IV d2 Vincristine 1.4 mg/m2 IV d2 Prednisone 60 mg/m2 PO d2-6 Frequency 21days 2 cycles of Rituximab monotherapy Rituximab 375 mg/m2 IV d1 Frequency 21days

Primary Outcome Measures

Name	Time	Method
Progression free survival	2-year

Secondary Outcome Measures

Name	Time	Method
Complete Response rate	21 days after 8 cycles of treatment（each cycle is 21 days）
Overall survival	2-year
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0	Each cycle of treatment（each cycle is 21 days）and then every 3 months for 2 years

Trial Locations

Locations (1)

Shanghai Ruijin Hospital; 🇨🇳 Shanghai, Shanghai, China