Bortezomib Maintenance in High Risk DLBCL (Borma)
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|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
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|Condition or disease||Intervention/treatment||Phase|
|Diffuse Large B Cell Lymphoma||Drug: Bortezomib||Phase 2|
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 (Clinical Trial)|
|Actual Enrollment :||59 participants|
|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|
bortezomib 1.3mg/m2 subcutaneous on day 1 and15
Bortezomib 1.3mg/m2, on day 1 and 15 SC Repeat every month for 12months
Other Name: velcade
- 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.
- 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.
- 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.
- 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.
- 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.
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|Ages Eligible for Study:||19 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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
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
|Korea, Republic of|
|Samsung Medical Center|
|Seoul, Korea, Republic of, 135-710|
|Principal Investigator:||Wonseog Kim, M.D., Ph.D.||Samsung Medical Center|
|Responsible Party:||Won Seog Kim, MD, Samsung Medical Center|
|Other Study ID Numbers:||
|First Posted:||October 18, 2013 Key Record Dates|
|Last Update Posted:||October 23, 2020|
|Last Verified:||October 2020|
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Immune System Diseases