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

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0005626

Enrollment

158

Registered

2020-11-24

Start date

2020-12-01

Completion date

Unknown

Last updated

2020-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : 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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

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

Design outcomes

Primary

Measure	Time frame
Infection rate after chemotherapy	—

Secondary

Measure	Time frame
Cycle of chemotherapy;Complete response rate;Overall survival;Progression free survival	—

Countries

Korea, Republic of

Contacts

Public ContactDong Won Baek

Kyungpook National University Hospital

Outcome results