Borma: Bortezomib Maintenance in High Risk DLBCL
Study Details
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)
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| 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.
Study Design
Arms and Interventions
| 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:
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Outcome Measures
Primary Outcome Measures
- 3years relapse free survival [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
- 3years overall survival [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 [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 [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 [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Newly histologically confirmed CD20 positive diffuse large B-cell lymphomas and only Non-GCB type will be included
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High intermediate or high risk by IPI risk, or Bulky mass ≥ 10cm at diagnosis
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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.
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Additional surgery or radiotherapy are accepted
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Age ≥ 20
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Performance status (ECOG) ≤ 2
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Adeqaute renal function: Cr < 2.5 mg/dL
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Adeqaute liver functions: Transaminase (AST/ALT) < 3 x upper normal value UNV)Bilirubin < 1.5 x UNV Alkaline phosphatase < 5 xUNV
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Adeqaute BM functions: ANC > 1,000/uL and platelet > 75,000/uL and hemoglobin > 9.0 g/dL
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Written Informed consent
Exclusion Criteria:
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Tumor response after 6-8 cycles CTx< CR
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Consider stem cell transplantation
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Central nervous system (CNS) metastases
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Pregnant or lactating women, patients of childbearing potential not employing adequate contraception
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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
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Any other malignancies within the past 5 years except curatively treated non- melanoma skin cancer or in situ carcinoma of cervix uteri.
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Prior history of allegic reaction to study treatment drugs
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Peripheral neuropathy grade 2 or worse
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DLBCL of the testis and primary mediastinal DLBCL
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Samsung Medical Center | Seoul | Korea, Republic of | 135-710 |
Sponsors and Collaborators
- Samsung Medical Center
- Janssen, LP
Investigators
- Principal Investigator: Wonseog Kim, M.D., Ph.D., Samsung Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SMC2013-04-124