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Multicenter, investigator initiated trial, investigating the efficacy and safety of IV-immunoglobulin therapy in elderly patients with diffuse large B cell lymphoma treated with R-CHOP

Status Approved

First Submitted Date

2020/11/10
Registered Date

2020/11/24
Last Updated Date

2020/10/29

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0005626
Unique Protocol ID	CNUHH-2020-194
Public/Brief Title	Multicenter, investigator initiated trial, investigating the efficacy and safety of IV-immunoglobulin therapy in elderly patients with diffuse large B cell lymphoma treated with R-CHOP
Scientific Title	Multicenter, investigator initiated trial, investigating the efficacy and safety of IV-immunoglobulin therapy in elderly patients with diffuse large B cell lymphoma treated with R-CHOP
Acronym	IVIG-DLBCL study
MFDS Regulated Study	Yes
IND/IDE Protocol
Registered at Other Registry	No
Healthcare Benefit Approval Status	Submitted pending

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	CNUHH-2020-194
Approval Date	2020-10-14
Institutional Review Board Name	chonnam national university hwasun hospital institutional review borard
Institutional Review Board Address	322, Seoyang-ro, Hwasun-eup, Hwasun-gun, Jeollanam-do
Institutional Review Board Telephone	061-379-7598
Data Monitoring Committee

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Deok-Hwan Yang
Title	professor
Telephone	+82-61-379-7636
Affiliation	Chonnam National University Hospital Hwasun Hospital
Address	322 Seoyang-ro, Hwasun-eup, Hwasun-gun, Jeollanamdo
Contact Person for Public Queries
Name	Dong Won Baek
Title	Assistant professor
Telephone	+82-53-200-5568
Affiliation	Kyungpook National University Hospital
Address	130 Dongdeok-ro,Jung-gu,Daegu 41944
Contact Person for Updating Information
Name	Dong Won Baek
Title	Assistant professor
Telephone	+82-53-200-5568
Affiliation	Kyungpook National University Hospital
Address	130 Dongdeok-ro,Jung-gu,Daegu 41944

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Multi-center Number of center : 2
Overall Recruitment Status	Not yet recruiting
Date of First Enrollment	2020-12-01 Anticipated
Target Number of Participant	158
Primary Completion Date	2023-12-31 , Anticipated
Study Completion Date	2023-12-31 , Anticipated
Name of Study	Chonnam National University Hospital Hwasun Hospital
Recruitment Status	Not yet recruiting
Date of First Enrollment	2020-12-01 ,
Recruitment Status by Participating Study Site 2
Name of Study	Kyungpook National University Hospital
Recruitment Status	Not yet recruiting
Date of First Enrollment	2020-12-01 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	Green Cross
Organization Type	Pharmaceutical Company
Project ID

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Chonnam National University Hospital Hwasun Hospital
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	This multicenter phase II study is to investigate the efficacy and safety of IV-immunoglobulin therapy in elderly patients with newly diagnosed with diffuse large B cell lymphoma treated with R-CHOP chemotherapy. The purpose of this study is to reduce the infection rate after R-CHOP chemotherapy and to improve the clinical outcome in elderly patients from 65 through 74 years old. Patients are randomized to the study and control groups. Patients in the study group receive IV-immunoglobulin between 7 to 10 days after R-CHOP plus Peg-G-CSF therapy. Patients in the control group receive R-CHOP plus Peg-G-CSF therapy.

Study Summary Information

Lay Summary

This multicenter phase II study is to investigate the efficacy and safety of IV-immunoglobulin therapy in elderly patients with newly diagnosed with diffuse large B cell lymphoma treated with R-CHOP chemotherapy. The purpose of this study is to reduce the infection rate after R-CHOP chemotherapy and to improve the clinical outcome in elderly patients from 65 through 74 years old. Patients are randomized to the study and control groups. Patients in the study group receive IV-immunoglobulin between 7 to 10 days after R-CHOP plus Peg-G-CSF therapy. Patients in the control group receive R-CHOP plus Peg-G-CSF therapy.

8. Study Design

Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
Study Type	Interventional Study
Study Purpose	Prevention
Phase	Phase2
Intervention Model	Parallel
Blinding/Masking	Open
Allocation	RCT
Intervention Type	Drug
Intervention Description	Elderly patients (65 ~ 75 years old) who newly diagnosed with diffuse large B cell lymphoma are assigned randomly to R-CHOP, Peg-G-CSF plus IV-immunoglobulin therapy group, and control group (R-CHOP plus Peg-G-CSF).
Number of Arms	2
Arm 1	Arm Label IV-immunoglobulin
	Target Number of Participant 79
	Arm Type Experimental
	Arm Description Elderly patients who newly diagnosed with diffuse large B cell lymphoma receive IV-immunoglobulin 400mg/Kg intravenously between 7 to 10 days after standard R-CHOP chemotherapy, every 3 weeks, 6 cycles.
Arm 2	Arm Label Patients who receive standard chemotherapy only without IV-immunoglobulin
	Target Number of Participant 79
	Arm Type No intervention
	Arm Description Patients are going to receive standard chemotherapy only (R-CHOP plus Peg-G-CSF).

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	(D50-D89)Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism Lymphoma, Non-Hodgkin
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 65Year~74Year
	Description 1. Untreated, newly diagnosed with diffuse large B cell lymphoma 2. Patients who understand and agree with this study protocol 3. Patients who can follow instructions and study protocol 4. Age between 65 to 74 years old, male and female 5. Ann arbor stage II, III or IV 6. Patients who can receive standard R-CHOP chemotherapy 7. ECOG PS 0, 1 or 2
Exclusion Criteria	1. Clinically significant uncontrolled systemic disease 2. Treatment history of immunotherapy or other chemotherapy for diffuse large B cell lymphoma, except corticosteroid less than 8days 3. Ann arbor stage I 5. Treatment history of radiotherapy for diffuse large B cell lymphoma 6. Central nervous system involvement 7. Patients who can not receive R-CHOP therapy 8. Known history of infection with HIV 9. Absolute neutrophil count < 1,500/mm3 10. Platelet count < 75,000/mm3 11. Serum creatinine ≥ 2.0 mg/dl or GFR < 50 mL/min 12. Serum bilirubin ≥ 2 x upper limit of normal (ULN) 13. SGOT/AST or SGPT/ALT ≥ 3 x ULN 14. Prior malignancy (or any other malignancy that requires active treatment), except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, papillary thyroid carcinoma, or other cancer from which the subject has been disease free for over 5 years or which will not limit survival to less than 5 years 15.MUGA scan or TTE Ejection fraction < 45% 16. Treatment history with doxorubicin over 200mg/m2 17. Concurrent participation in another therapeutic clinical trial
Healthy Volunteers	No

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	/Safety/Efficacy
Outcome	Infection rate after chemotherapy
Timepoint	After chemotherapy
Secondary Outcome(s) 1
Outcome	Cycle of chemotherapy
Timepoint	After chemotherapy
Secondary Outcome(s) 2
Outcome	Complete response rate
Timepoint	After chemotherapy
Secondary Outcome(s) 3
Outcome	Overall survival
Timepoint	After chemotherapy
Secondary Outcome(s) 4
Outcome	Progression free survival
Timepoint	After chemotherapy

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	No

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