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Bortezomib Maintenance in High Risk DLBCL (Borma)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01965977
Recruitment Status : Unknown
Verified October 2020 by Won Seog Kim, Samsung Medical Center.
Recruitment status was:  Active, not recruiting
First Posted : October 18, 2013
Last Update Posted : October 23, 2020
Sponsor:
Collaborator:
Janssen, LP
Information provided by (Responsible Party):
Won Seog Kim, Samsung Medical Center

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)

Condition or disease Intervention/treatment Phase
Diffuse Large B Cell Lymphoma Drug: Bortezomib Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Open-label, Multicenter Phase II Study of Bortezomib for Maintenance Therapy in Patients With High Risk Diffuse Large B Cell Lymphoma
Actual Study Start Date : April 8, 2015
Actual Primary Completion Date : October 30, 2018
Estimated Study Completion Date : October 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Bortezomib

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 Name: velcade




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01965977


Locations
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Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
Janssen, LP
Investigators
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Principal Investigator: Wonseog Kim, M.D., Ph.D. Samsung Medical Center
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Responsible Party: Won Seog Kim, MD, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01965977    
Other Study ID Numbers: SMC2013-04-124
First Posted: October 18, 2013    Key Record Dates
Last Update Posted: October 23, 2020
Last Verified: October 2020
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Bortezomib
Antineoplastic Agents