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Bortezomib Maintenance in High Risk DLBCL (Borma)

Primary Purpose

Diffuse Large B Cell Lymphoma

Status

Unknown status

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Bortezomib

About this trial

This is an interventional basic science trial for Diffuse Large B Cell Lymphoma

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Samsung Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bortezomib

Arm Description

bortezomib 1.3mg/m2 subcutaneous on day 1 and15

Outcomes

Primary Outcome Measures

3years relapse free survival

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

Secondary Outcome Measures

3years overall survival

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

3years event free survival

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

Toxicity profiles

Safety profiles will be evaluated using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

Quality of life scale

Quality of life will be assessed after starting maintenance therapy for 1year and then following up for 3years by using FACT&GOG-Ntx.

Full Information

NCT ID

NCT01965977

First Posted

October 16, 2013

Last Updated

October 21, 2020

Sponsor

Samsung Medical Center

Collaborators

Janssen, LP

1. Study Identification

Unique Protocol Identification Number

NCT01965977

Brief Title

Bortezomib Maintenance in High Risk DLBCL

Acronym

Borma

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Unknown status

Study Start Date

April 8, 2015 (Actual)

Primary Completion Date

October 30, 2018 (Actual)

Study Completion Date

October 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Samsung Medical Center

Collaborators

Janssen, LP

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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)

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diffuse Large B Cell Lymphoma

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

59 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Bortezomib

Arm Type

Experimental

Arm Description

bortezomib 1.3mg/m2 subcutaneous on day 1 and15

Intervention Type

Drug

Intervention Name(s)

Bortezomib

Other Intervention Name(s)

velcade

Intervention Description

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

Primary Outcome Measure Information:

Title

3years relapse free survival

Description

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

Time Frame

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

Secondary Outcome Measure Information:

Title

3years overall survival

Description

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

Time Frame

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

Title

3years event free survival

Description

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

Time Frame

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

Title

Toxicity profiles

Description

Safety profiles will be evaluated using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

Time Frame

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

Title

Quality of life scale

Description

Quality of life will be assessed after starting maintenance therapy for 1year and then following up for 3years by using FACT&GOG-Ntx.

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wonseog Kim, M.D., Ph.D.

Organizational Affiliation

Samsung Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Samsung Medical Center

City

Seoul

ZIP/Postal Code

135-710

Country

Korea, Republic of

12. IPD Sharing Statement

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Bortezomib Maintenance in High Risk DLBCL

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