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Biomarker Guided Treatment in DLBCL

Shanghai Jiao Tong University logo

Shanghai Jiao Tong University

Status and phase

Unknown
Phase 2

Conditions

Diffuse Large B Cell Lymphoma

Treatments

Drug: decitabine
Drug: Cyclophosphamide
Drug: chidamide
Drug: Lenalidomide
Drug: Rituximab
Drug: Ibrutinib
Drug: Prednisone
Drug: Doxorubicin
Drug: Vincristine

Study type

Interventional

Funder types

Other

Identifiers

NCT04025593
Guidance-01

Details and patient eligibility

About

This study is to investigate the strategy of biomarker guided treatment in diffuse large B cell lymphoma

Enrollment

128 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Pathologically confirmed diffuse large B-cell lymphoma, CD20 positive
  • ECOG 0,1,2
  • Life expectancy>6 months
  • Informed consented
  • IPI>1

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 CNS lymphoma
  • LVEF≤50%
  • Lab at enrollment (Unless caused by lymphoma) Neutrophile<1.5*10^9/L Platelet<75*10^9/L ALT or AST >2*ULN,AKP or bilirubin >1.5*ULN Creatinine>1.5*ULN Other uncontrollable medical condition that may that may interfere the participation of the study Not able to comply to the protocol for mental or other unknown reasons Pregnant or lactation HIV infection 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

128 participants in 2 patient groups

RCHOP
Active Comparator group
Treatment:
Drug: Prednisone
Drug: Doxorubicin
Drug: Rituximab
Drug: Cyclophosphamide
Drug: Vincristine
RCHOPX
Experimental group
Treatment:
Drug: Prednisone
Drug: Doxorubicin
Drug: decitabine
Drug: chidamide
Drug: Rituximab
Drug: Cyclophosphamide
Drug: Ibrutinib
Drug: Lenalidomide
Drug: Vincristine

Trial contacts and locations

1

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Central trial contact

WL Z, MD PhD

Data sourced from clinicaltrials.gov

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