Bortezomib Maintenance in High Risk DLBCL (Borma)

October 21, 2020 updated by: Won Seog Kim, Samsung Medical Center

Open-label, Multicenter Phase II Study of Bortezomib for Maintenance Therapy in Patients With High Risk Diffuse Large B Cell Lymphoma

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)

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

High-intermediate or high risk in IPI has a long-term chance of cure in the range about 50% in patients with DLBCL treated by R-CHOP. These high risk patients should be considered for additional new treatment to standard R-CHOP or investigational approaches in the context of clinical trials that are designed to ensure that potentially curative therapy.

Bortezomib has shown activity in vitro against DLBCL-derived cell lines. Single-agent bortezomib or chemotherapy combined bortezomib are feasible in follicular, mantle cell, marginal zone lymphoma and DLBCL with manageable toxicities. Bortezomib enhances the activity of chemotherapy in non-GCB but not GCB DLBCL, and provide a rational therapeutic approach based on genetically distinct DLBCL subtypes.

High CR/CRu rate with bortezomib with standard R-CHOP suggests it may be a good backbone for additional maintenance leading to durable response. However, there is no study of bortezomib as maintenance therapy after treated with R-CHOP in high risk patients with DLBCL. So we applied additional bortezomib as maintenance therapy in order to assess improving efficacy and survival rates in high risk patients with non-GCB DLBCL who had been confirmed CR after treated with R-CHOP.

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bortezomib
bortezomib 1.3mg/m2 subcutaneous on day 1 and15
Drug: Bortezomib
Bortezomib 1.3mg/m2, on day 1 and 15 SC Repeat every month for 12months
Other Names:
  • velcade

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3years relapse free survival
Time Frame: from the date of first drug administration until the date of last follow up, assessed up to 4years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
3years overall survival
Time Frame: from the date of first drug administration until the date of last follow up, assessed up to 4years
3years overall 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
3years event free survival
Time Frame: from the date of first drug administration until the date of last follow up, assessed up to 4years
3years event 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
Toxicity profiles
Time Frame: from the date of first drug administration until the date of the 30th day after last cycle of chemotherapy
Safety profiles will be evaluated using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
from the date of first drug administration until the date of the 30th day after last cycle of chemotherapy
Quality of life scale
Time Frame: from the date of first drug administration until the date of last follow up, assessed up to 4years
Quality of life will be assessed after starting maintenance therapy for 1year and then following up for 3years by using FACT&GOG-Ntx.
from the date of first drug administration until the date of last follow up, assessed up to 4years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Collaborators

Janssen, LP

Investigators

  • Principal Investigator: Wonseog Kim, M.D., Ph.D., Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 8, 2015

Primary Completion (Actual)

October 30, 2018

Study Completion (Anticipated)

October 30, 2021

Study Registration Dates

First Submitted

October 16, 2013

First Submitted That Met QC Criteria

October 16, 2013

First Posted (Estimate)

October 18, 2013

Study Record Updates

Last Update Posted (Actual)

October 23, 2020

Last Update Submitted That Met QC Criteria

October 21, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMC2013-04-124

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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