Biomarker Guided Treatment in DLBCL

Sponsor

Ruijin Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04025593

Collaborator

(none)

128

Enrollment

Location

Arms

46.5

Anticipated Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Diffuse Large B Cell Lymphoma	Drug: Cyclophosphamide Drug: Rituximab Drug: Doxorubicin Drug: Vincristine Drug: Prednisone Drug: Ibrutinib Drug: Lenalidomide Drug: chidamide Drug: decitabine	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

128 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Randomized, Phase 2 Study of Biomarker Guided Treatment in DLBCL

Actual Study Start Date :

Jul 17, 2019

Anticipated Primary Completion Date :

Jul 1, 2021

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: RCHOP	Drug: Cyclophosphamide 750mg/m2 day 1 Drug: Rituximab 375mg/m2 day 0 Drug: Doxorubicin 50mg/m2 day 1 Drug: Vincristine 1.4mg/m2, max 2mg day 1 Drug: Prednisone 60mg/m2, max 100mg day 1-5
Experimental: RCHOPX	Drug: Cyclophosphamide 750mg/m2 day 1 Drug: Rituximab 375mg/m2 day 0 Drug: Doxorubicin 50mg/m2 day 1 Drug: Vincristine 1.4mg/m2, max 2mg day 1 Drug: Prednisone 60mg/m2, max 100mg day 1-5 Drug: Ibrutinib 420mg/day qd Drug: Lenalidomide 25mg day1-10 Drug: chidamide 20mg day 1,4,8,11 Drug: decitabine decitabine 10mg/m2 day-5 to day-1

Arm

Intervention/Treatment

Active Comparator: RCHOP

Drug: Cyclophosphamide

750mg/m2 day 1

Drug: Rituximab

375mg/m2 day 0

Drug: Doxorubicin

50mg/m2 day 1

Drug: Vincristine

1.4mg/m2, max 2mg day 1

Drug: Prednisone

60mg/m2, max 100mg day 1-5

Experimental: RCHOPX

Drug: Cyclophosphamide

750mg/m2 day 1

Drug: Rituximab

375mg/m2 day 0

Drug: Doxorubicin

50mg/m2 day 1

Drug: Vincristine

1.4mg/m2, max 2mg day 1

Drug: Prednisone

60mg/m2, max 100mg day 1-5

Drug: Ibrutinib

420mg/day qd

Drug: Lenalidomide

25mg day1-10

Drug: chidamide

20mg day 1,4,8,11

Drug: decitabine

decitabine 10mg/m2 day-5 to day-1

Outcome Measures

Primary Outcome Measures

complete response rate [21 days after 6 cycles of treatment (each cycle is 21 days)]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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<1.510^9/L Platelet<7510^9/L ALT or AST >2ULN,AKP or bilirubin >1.5ULN 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.