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Biomarker Guided Treatment in DLBCL

Primary Purpose

Diffuse Large B Cell Lymphoma

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Cyclophosphamide

Rituximab

Doxorubicin

Vincristine

Prednisone

Ibrutinib

Lenalidomide

chidamide

decitabine

About this trial

This is an interventional treatment trial for Diffuse Large B Cell Lymphoma

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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<1.5*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.

Sites / Locations

Ruijin hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

RCHOP

RCHOPX

Arm Description

Outcomes

Primary Outcome Measures

complete response rate

Secondary Outcome Measures

progression free survival

overall survival

overall response rate

Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0

Full Information

NCT ID

NCT04025593

First Posted

July 17, 2019

Last Updated

November 17, 2020

Sponsor

Ruijin Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04025593

Brief Title

Biomarker Guided Treatment in DLBCL

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Unknown status

Study Start Date

July 17, 2019 (Actual)

Primary Completion Date

July 1, 2021 (Anticipated)

Study Completion Date

June 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ruijin Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diffuse Large B Cell Lymphoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

RCHOP

Arm Type

Active Comparator

Arm Title

RCHOPX

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Cyclophosphamide

Intervention Description

750mg/m2 day 1

Intervention Type

Drug

Intervention Name(s)

Rituximab

Intervention Description

375mg/m2 day 0

Intervention Type

Drug

Intervention Name(s)

Doxorubicin

Intervention Description

50mg/m2 day 1

Intervention Type

Drug

Intervention Name(s)

Vincristine

Intervention Description

1.4mg/m2, max 2mg day 1

Intervention Type

Drug

Intervention Name(s)

Prednisone

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Ibrutinib

Intervention Description

420mg/day qd

Intervention Type

Drug

Intervention Name(s)

Lenalidomide

Intervention Description

25mg day1-10

Intervention Type

Drug

Intervention Name(s)

chidamide

Intervention Description

20mg day 1,4,8,11

Intervention Type

Drug

Intervention Name(s)

decitabine

Intervention Description

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

Primary Outcome Measure Information:

Title

complete response rate

Time Frame

21 days after 6 cycles of treatment (each cycle is 21 days)

Secondary Outcome Measure Information:

Title

progression free survival

Time Frame

2 year

Title

overall survival

Time Frame

2 year

Title

overall response rate

Time Frame

21 days after 6 cycles of treatment (each cycle is 21 days)

Title

Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0

Time Frame

Up to 30 days after completion of study treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

WL Z, MD PhD

Phone

64370045

Ext

610707

zhao.weili@yahoo.com

Facility Information:

Facility Name

Ruijin hospital

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200025

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pp X, MD, PhD

Phone

86-21-64370045

Ext

610707

xpproc@msn.com

First Name & Middle Initial & Last Name & Degree

WL Z, MD, PhD

First Name & Middle Initial & Last Name & Degree

PP X, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD

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Biomarker Guided Treatment in DLBCL

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