Reduced Chemotherapy in Low Risk DLBCL

Sponsor

Ruijin Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02752815

Collaborator

(none)

290

Enrollment

Location

Arms

Anticipated Duration (Months)

5.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diffuse Large B-cell Lymphoma	Drug: Rituximab Drug: Cyclophosphamide Drug: Epirubicin Drug: Vincristine Drug: Prednisone	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

290 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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.

Actual Study Start Date :

Apr 1, 2016

Anticipated Primary Completion Date :

Apr 1, 2020

Anticipated Study Completion Date :

Jun 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 6R-CHOP+2R 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	Drug: Rituximab Drug: Cyclophosphamide Drug: Epirubicin Drug: Vincristine Drug: Prednisone
Experimental: 4R-CHOP+4R 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	Drug: Rituximab Drug: Cyclophosphamide Drug: Epirubicin Drug: Vincristine Drug: Prednisone

Arm

Intervention/Treatment

Active Comparator: 6R-CHOP+2R

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

Drug: Rituximab

Drug: Cyclophosphamide

Drug: Epirubicin

Drug: Vincristine

Drug: Prednisone

Experimental: 4R-CHOP+4R

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

Drug: Rituximab

Drug: Cyclophosphamide

Drug: Epirubicin

Drug: Vincristine

Drug: Prednisone

Outcome Measures

Primary Outcome Measures

Progression free survival [2-year]

Secondary Outcome Measures

Overall survival [2-year]
Complete Response rate [21 days after 8 cycles of treatment（each cycle is 21 days）]
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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<1.510^9/L Platelet<8010^9/L Hemoglobulin<100g/L ALT or AST >2ULN,AKP or bilirubin >1.5ULN 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