Biomarker Guided Treatment in DLBCL

Conditions

Diffuse Large B Cell Lymphoma

Brief summary

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

Ying Fang, Mu‐Chen Zhang, Yang He, Chen Li, Hai Fang et al. (12 authors)

Signal Transduction and Targeted Therapy2023-10-0627 citations

10.1038/s41392-023-01626-x

Genetic subtype-guided immunochemotherapy in diffuse large B cell lymphoma: The randomized GUIDANCE-01 trial

Mu‐Chen Zhang, Shuang Tian, Di Fu, Li Wang, Shu Cheng et al. (19 authors)

Cancer Cell2023-09-2893 citations

10.1016/j.ccell.2023.09.004

GENETIC SUBTYPE GUIDED RITUXIMAB‐BASED IMMUNOCHEMOTHERAPY IMPROVES OUTCOME IN NEWLY DIAGNOSED DIFFUSE LARGE B‐CELL LYMPHOMA: FIRST REPORT OF A RANDOMIZED PHASE 2 STUDY

M Zhang, Peng Xu, L Wang, Shangli Cheng, Weili Zhao

Hematological Oncology2021-06-0113 citations

10.1002/hon.26_2879

Interventions

DRUGCyclophosphamide

750mg/m2 day 1

DRUGRituximab

375mg/m2 day 0

DRUGDoxorubicin

50mg/m2 day 1

DRUGVincristine

1.4mg/m2, max 2mg day 1

DRUGPrednisone

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

DRUGIbrutinib

420mg/day qd

DRUGLenalidomide

25mg day1-10

DRUGchidamide

20mg day 1,4,8,11

DRUGdecitabine

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

No

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

China

Contacts

Primary ContactWL Z, MD PhD

zhao.weili@yahoo.com64370045

Outcome results

None listed