Biomarker Guided Treatment in DLBCL

November 17, 2020 updated by: Zhao Weili, Ruijin Hospital

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

128

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200025
        • Recruiting
        • Ruijin Hospital
        • Contact:
          • Pp X, MD, PhD
          • Phone Number: 610707 86-21-64370045
          • Email: xpproc@msn.com
        • Principal Investigator:
          • WL Z, MD, PhD
        • Sub-Investigator:
          • PP X, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
progression free survival
Time Frame: 2 year
2 year
overall survival
Time Frame: 2 year
2 year
overall response rate
Time Frame: 21 days after 6 cycles of treatment (each cycle is 21 days)
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
Time Frame: Up to 30 days after completion of study treatment
Up to 30 days after completion of study treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruijin Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 17, 2019

Primary Completion (Anticipated)

July 1, 2021

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

July 17, 2019

First Submitted That Met QC Criteria

July 17, 2019

First Posted (Actual)

July 19, 2019

Study Record Updates

Last Update Posted (Actual)

November 19, 2020

Last Update Submitted That Met QC Criteria

November 17, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Guidance-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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