Biomarker Guided Treatment in DLBCL

Diffuse Large B Cell Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04025593
• Other study ID #: Guidance-01
• Status: Recruiting
• Phase: Phase 2
• Start date: July 17, 2019
• Est. completion date: June 1, 2023

Study information

• Verified date: November 2020
• Source: Ruijin Hospital
• Contact: WL Z, MD PhD
• Phone: 64370045
• Email: zhao.weili[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 128
• Est. completion date: June 1, 2023
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diffuse Large B Cell Lymphoma
• Lymphoma, Large B-Cell, Diffuse

Intervention

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

Locations

Country	Name	City	State
China	Ruijin hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	complete response rate		21 days after 6 cycles of treatment (each cycle is 21 days)
Secondary	progression free survival		2 year
Secondary	overall survival		2 year
Secondary	overall response rate		21 days after 6 cycles of treatment (each cycle is 21 days)
Secondary	Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0		Up to 30 days after completion of study treatment