Biomarker Guided Treatment in DLBCL

Phase 2

• Conditions: Diffuse Large B Cell Lymphoma
• Interventions: Drug: Cyclophosphamide; Drug: Rituximab; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone; Drug: Ibrutinib; Drug: Lenalidomide; Drug: chidamide; Drug: decitabine

• Registration Number: NCT04025593
• Lead Sponsor: Ruijin Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-17
• Study First Submitted: 2019-07-17
• Study First Submitted QC: 2019-07-17
• Study First Posted: 2019-07-19
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-17
• Last Update Posted: 2020-11-19
• Primary Completion: 2021-07-01
• Study Completion: 2023-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 128

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RCHOP	Cyclophosphamide	-
RCHOP	Rituximab	-
RCHOP	Doxorubicin	-
RCHOP	Vincristine	-
RCHOPX	Cyclophosphamide	-
RCHOP	Prednisone	-
RCHOPX	Rituximab	-
RCHOPX	Doxorubicin	-
RCHOPX	Prednisone	-
RCHOPX	Vincristine	-
RCHOPX	Ibrutinib	-
RCHOPX	Lenalidomide	-
RCHOPX	chidamide	-
RCHOPX	decitabine	-

Primary Outcome Measures

Name	Time	Method
complete response rate	21 days after 6 cycles of treatment (each cycle is 21 days)

Secondary Outcome Measures

Name	Time	Method
progression free survival	2 year
overall survival	2 year
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0	Up to 30 days after completion of study treatment
overall response rate	21 days after 6 cycles of treatment (each cycle is 21 days)

Trial Locations

Locations (1)

Ruijin hospital; 🇨🇳 Shanghai, Shanghai, China