Biomarker Guided Treatment in DLBCL

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