Reduced Chemotherapy in Low Risk DLBCL

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Shanghai Jiao Tong University

Status and phase

Active, not recruiting
Phase 4

Conditions

Diffuse Large B-cell Lymphoma

Treatments

Drug: Epirubicin
Drug: Rituximab
Drug: Vincristine
Drug: Prednisone
Drug: Cyclophosphamide

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)

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: Prednisone
Drug: Cyclophosphamide
Drug: Vincristine
Drug: Rituximab
Drug: Epirubicin
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: Prednisone
Drug: Cyclophosphamide
Drug: Vincristine
Drug: Rituximab
Drug: Epirubicin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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