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Reduced Chemotherapy in Low Risk DLBCL

Primary Purpose

Diffuse Large B-cell Lymphoma

Status
Active
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Rituximab
Cyclophosphamide
Epirubicin
Vincristine
Prednisone
Sponsored by
Ruijin Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diffuse Large B-cell Lymphoma

Eligibility Criteria

14 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Histologically confirmed de novo diffuse large B-cell lymphoma, complete response after 4 cycles of standard R-CHOP21
  • Age>=14 y.o.,<=75 y.o.
  • IPI=0-1
  • non-bulky (largest diameter <7.5cm)
  • ECOG =0-1
  • Life expectancy>6 months
  • Informed consented

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 cutaneous, CNS DLBCL
  • LVEF≤50%
  • Other uncontrollable medical condition that may that may interfere the participation of the study
  • Lab at enrollment(unless caused by lymphoma) Neutrophile<1.5*10^9/L Platelet<80*10^9/L Hemoglobulin<100g/L ALT or AST >2*ULN,AKP or bilirubin >1.5*ULN Creatinine>1.5*ULN
  • Not able to comply to the protocol for mental or other unknown reasons
  • Pregnant or lactation
  • 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.
  • HIV infection

Sites / Locations

  • Shanghai Ruijin Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

6R-CHOP+2R

4R-CHOP+4R

Arm Description

6 cycles of R-CHOP Rituximab 375 mg/m2 IV d1 Cyclophosphamide 750mg/m2 IV d2 Epirubicin 70mg/m2 IV d2 Vincristine 1.4 mg/m2 IV d2 Prednisone 60 mg/m2 PO d2-6 Frequency 21days 2 cycles of Rituximab monotherapy Rituximab 375 mg/m2 IV d1 Frequency 21days

4 cycles of R-CHOP Rituximab 375 mg/m2 IV d1 Cyclophosphamide 750mg/m2 IV d2 Epirubicin 70mg/m2 IV d2 Vincristine 1.4 mg/m2 IV d2 Prednisone 60 mg/m2 PO d2-6 Frequency 21days 2 cycles of Rituximab monotherapy Rituximab 375 mg/m2 IV d1 Frequency 21days

Outcomes

Primary Outcome Measures

Progression free survival

Secondary Outcome Measures

Overall survival
Complete Response rate
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0

Full Information

First Posted
April 20, 2016
Last Updated
December 1, 2022
Sponsor
Ruijin Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02752815
Brief Title
Reduced Chemotherapy in Low Risk DLBCL
Official Title
Four Cycles of R-CHOP Followed by Four Cycles of Rituximab Versus Six Cycles of R-CHOP Followed by Two Cycles of Rituximab in the Treatment of de Novo, Low-risk, Non-bulky Diffuse Large B-cell Lymphoma.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 14, 2016 (Actual)
Primary Completion Date
October 30, 2022 (Actual)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruijin Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a clinical trial to compare the efficacy and safety of four cycles of R-CHOP followed by four cycles of Rituximab with six cycles of R-CHOP followed by two cycles of Rituximab in the treatment of de novo, low-risk, non-bulky 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 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
290 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
6R-CHOP+2R
Arm Type
Active Comparator
Arm Description
6 cycles of R-CHOP Rituximab 375 mg/m2 IV d1 Cyclophosphamide 750mg/m2 IV d2 Epirubicin 70mg/m2 IV d2 Vincristine 1.4 mg/m2 IV d2 Prednisone 60 mg/m2 PO d2-6 Frequency 21days 2 cycles of Rituximab monotherapy Rituximab 375 mg/m2 IV d1 Frequency 21days
Arm Title
4R-CHOP+4R
Arm Type
Experimental
Arm Description
4 cycles of R-CHOP Rituximab 375 mg/m2 IV d1 Cyclophosphamide 750mg/m2 IV d2 Epirubicin 70mg/m2 IV d2 Vincristine 1.4 mg/m2 IV d2 Prednisone 60 mg/m2 PO d2-6 Frequency 21days 2 cycles of Rituximab monotherapy Rituximab 375 mg/m2 IV d1 Frequency 21days
Intervention Type
Drug
Intervention Name(s)
Rituximab
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
Epirubicin
Intervention Type
Drug
Intervention Name(s)
Vincristine
Intervention Type
Drug
Intervention Name(s)
Prednisone
Primary Outcome Measure Information:
Title
Progression free survival
Time Frame
2-year
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
2-year
Title
Complete Response rate
Time Frame
21 days after 8 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
Each cycle of treatment（each cycle is 21 days）and then every 3 months for 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed de novo diffuse large B-cell lymphoma, complete response after 4 cycles of standard R-CHOP21 Age>=14 y.o.,<=75 y.o. IPI=0-1 non-bulky (largest diameter <7.5cm) ECOG =0-1 Life expectancy>6 months Informed consented 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 cutaneous, CNS DLBCL LVEF≤50% Other uncontrollable medical condition that may that may interfere the participation of the study Lab at enrollment(unless caused by lymphoma) Neutrophile<1.5*10^9/L Platelet<80*10^9/L Hemoglobulin<100g/L ALT or AST >2*ULN,AKP or bilirubin >1.5*ULN Creatinine>1.5*ULN Not able to comply to the protocol for mental or other unknown reasons Pregnant or lactation 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. HIV infection
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weili Zhao, MD, PhD
Organizational Affiliation
Ruijin Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Ruijin Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200023
Country
China

12. IPD Sharing Statement

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Reduced Chemotherapy in Low Risk DLBCL

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