Biomarker Guided Treatment in DLBCL

NCT ID: NCT04025593

Last Updated: 2020-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-17

Study Completion Date

2023-06-01

Brief Summary

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

Detailed Description

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Conditions

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Diffuse Large B Cell Lymphoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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RCHOP

Group Type ACTIVE_COMPARATOR

Cyclophosphamide

Intervention Type DRUG

750mg/m2 day 1

Rituximab

Intervention Type DRUG

375mg/m2 day 0

Doxorubicin

Intervention Type DRUG

50mg/m2 day 1

Vincristine

Intervention Type DRUG

1.4mg/m2, max 2mg day 1

Prednisone

Intervention Type DRUG

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

RCHOPX

Group Type EXPERIMENTAL

Cyclophosphamide

Intervention Type DRUG

750mg/m2 day 1

Rituximab

Intervention Type DRUG

375mg/m2 day 0

Doxorubicin

Intervention Type DRUG

50mg/m2 day 1

Vincristine

Intervention Type DRUG

1.4mg/m2, max 2mg day 1

Prednisone

Intervention Type DRUG

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

Ibrutinib

Intervention Type DRUG

420mg/day qd

Lenalidomide

Intervention Type DRUG

25mg day1-10

chidamide

Intervention Type DRUG

20mg day 1,4,8,11

decitabine

Intervention Type DRUG

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

Interventions

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Cyclophosphamide

750mg/m2 day 1

Intervention Type DRUG

Rituximab

375mg/m2 day 0

Intervention Type DRUG

Doxorubicin

50mg/m2 day 1

Intervention Type DRUG

Vincristine

1.4mg/m2, max 2mg day 1

Intervention Type DRUG

Prednisone

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

Intervention Type DRUG

Ibrutinib

420mg/day qd

Intervention Type DRUG

Lenalidomide

25mg day1-10

Intervention Type DRUG

chidamide

20mg day 1,4,8,11

Intervention Type DRUG

decitabine

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ruijin Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhao Weili

Deputy director of hematology department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ruijin hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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WL Z, MD PhD

Role: CONTACT

Phone: 64370045

Email: [email protected]

Facility Contacts

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Pp X, MD, PhD

Role: primary

Other Identifiers

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Guidance-01

Identifier Type: -

Identifier Source: org_study_id