Bortezomib Maintenance in High Risk DLBCL

NCT01965977 | Unknown Phase 2 DMC

• 1 other identifier: SMC2013-04-124
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Diffuse Large B Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• 3years relapse free survival

  3years relapse free survival will be assessed after starting maintenance therapy for 1year and then following up for 3years.

  from the date of first drug administration until the date of last follow up, assessed up to 4years

Secondary Outcomes (4)

• 3years overall survival

  from the date of first drug administration until the date of last follow up, assessed up to 4years

• 3years event free survival

  from the date of first drug administration until the date of last follow up, assessed up to 4years

• Toxicity profiles

  from the date of first drug administration until the date of the 30th day after last cycle of chemotherapy

• Quality of life scale

  from the date of first drug administration until the date of last follow up, assessed up to 4years

Study Arms (1)

Bortezomib

EXPERIMENTAL

bortezomib 1.3mg/m2 subcutaneous on day 1 and15

Drug: Bortezomib

Interventions

Bortezomib DRUG

Bortezomib 1.3mg/m2, on day 1 and 15 SC Repeat every month for 12months

Also known as: velcade

Bortezomib

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Newly histologically confirmed CD20 positive diffuse large B-cell lymphomas and only Non-GCB type will be included
• High intermediate or high risk by IPI risk, or Bulky mass ≥ 10cm at diagnosis
• 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.
• Additional surgery or radiotherapy are accepted
• Age ≥ 20
• Performance status (ECOG) ≤ 2
• Adeqaute renal function: Cr \< 2.5 mg/dL
• Adeqaute liver functions: Transaminase (AST/ALT) \< 3 x upper normal value UNV)Bilirubin \< 1.5 x UNV Alkaline phosphatase \< 5 xUNV
• Adeqaute BM functions: ANC \> 1,000/uL and platelet \> 75,000/uL and hemoglobin \> 9.0 g/dL
• Written Informed consent

You may not qualify if:

• Tumor response after 6-8 cycles CTx\< CR
• Consider stem cell transplantation
• Central nervous system (CNS) metastases
• Pregnant or lactating women, patients of childbearing potential not employing adequate contraception
• 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
• Any other malignancies within the past 5 years except curatively treated non- melanoma skin cancer or in situ carcinoma of cervix uteri.
• Prior history of allegic reaction to study treatment drugs
• Peripheral neuropathy grade 2 or worse
• DLBCL of the testis and primary mediastinal DLBCL

Sponsors & Collaborators

• Samsung Medical Center: lead
• Janssen, LP: collaborator

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

Bortezomib

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Wonseog Kim, M.D., Ph.D.

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 16, 2013
• First Posted: October 18, 2013
• Study Start: April 8, 2015
• Primary Completion: October 30, 2018
• Study Completion: October 30, 2021
• Last Updated: October 23, 2020

Record last verified: 2020-10

Locations

KR (1)