Bortezomib Maintenance in High Risk DLBCL

• Status: Active, not recruiting
• Trial end date: 2021-10-30
• Target enrollment: 0
• Participant gender: All

Summary

This study is an Open-labeled, multicenter Phase II study of Bortezomib for maintenance therapy in patients with high risk diffuse large B cell lymphoma (DLBCL). Primary objective is 3 years relapse free survival (RFS) and Secondary objectives are 3 years overall survival (OS), 3 years event free survival (EFS),Toxicities profiles, Quality of Life (FACT&GOG-Ntx)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Samsung Medical Center
• Collaborator: Janssen, LP
• Treatments: Bortezomib

Criteria

Inclusion Criteria:

1. Newly histologically confirmed CD20 positive diffuse large B-cell lymphomas and only Non-GCB type will be included

2. High intermediate or high risk by IPI risk, or Bulky mass ≥ 10cm at diagnosis

3. Complete response is confirmed after six or eight cycles R-CHOP chemotherapy by CT scan with confirmed negative PET-CT based on the Revised International Workshop Criteria.

4. Additional surgery or radiotherapy are accepted

5. Age ≥ 20

6. Performance status (ECOG) ≤ 2

7. Adeqaute renal function: Cr < 2.5 mg/dL

8. Adeqaute liver functions: Transaminase (AST/ALT) < 3 x upper normal value UNV)Bilirubin < 1.5 x UNV Alkaline phosphatase < 5 xUNV

9. Adeqaute BM functions: ANC > 1,000/uL and platelet > 75,000/uL and hemoglobin > 9.0 g/dL

10. Written Informed consent

Exclusion Criteria:

1. Tumor response after 6-8 cycles CTx< CR

2. Consider stem cell transplantation

3. Central nervous system (CNS) metastases

4. Pregnant or lactating women, patients of childbearing potential not employing adequate contraception

5. Other serious illness or medical conditions A. Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry B. History of significant neurologic or psychiatric disorders including dementia or seizures C. Active uncontrolled infection

6. Any other malignancies within the past 5 years except curatively treated non- melanoma skin cancer or in situ carcinoma of cervix uteri.

7. Prior history of allegic reaction to study treatment drugs

8. Peripheral neuropathy grade 2 or worse

9. DLBCL of the testis and primary mediastinal DLBCL