Reduced Chemotherapy in Low Risk DLBCL

Diffuse Large B-cell Lymphoma Clinical Trial

Official title:

Four Cycles of R-CHOP Followed by Four Cycles of Rituximab Versus 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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02752815
• Other study ID #: NHL-006
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: June 14, 2016
• Est. completion date: December 31, 2024

Study information

• Verified date: December 2022
• Source: Ruijin Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 290
• Est. completion date: December 31, 2024
• Est. primary completion date: October 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diffuse Large B-cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Intervention

Drug:
• Rituximab

• Cyclophosphamide

• Epirubicin

• Vincristine

• Prednisone

Locations

Country	Name	City	State
China	Shanghai Ruijin Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival		2-year
Secondary	Overall survival		2-year
Secondary	Complete Response rate		21 days after 8 cycles of treatment(each cycle is 21 days)
Secondary	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