Reduced Chemotherapy in Low Risk DLBCL

Shanghai Jiao Tong University

Status and phase: Active, not recruiting; Phase 4

Conditions: Diffuse Large B-cell Lymphoma

Treatments: Drug: Epirubicin; Drug: Prednisone; Drug: Rituximab; Drug: Cyclophosphamide; Drug: Vincristine

Study type: Interventional

Funder types: Other

Identifiers

NCT02752815

NHL-006

Details and patient eligibility

About

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.

Enrollment: 290 estimated patients

Sex: All

Ages: 14 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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290 participants in 2 patient groups

6R-CHOP+2R

Active Comparator group

Description:

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

Treatment:

Drug: Epirubicin

Drug: Rituximab

Drug: Cyclophosphamide

Drug: Vincristine

Drug: Prednisone

4R-CHOP+4R

Experimental group

Description:

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

Treatment:

Drug: Epirubicin

Drug: Rituximab

Drug: Cyclophosphamide

Drug: Vincristine

Drug: Prednisone