A Study of Bortezomib Plus GDP in the Treatment of Refractory and Relapsed Non-GCB DLBCL
NCT ID: NCT02542111
Last Updated: 2017-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
30 participants
INTERVENTIONAL
2015-05-31
2018-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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V-GDP
Bortezomib 1.6 mg/m2/d iv d1 and d8 Gemcitabine 1000mg/m2/d iv d1 and d8 Dexamethasone 40mg/d iv d1-4 cisplatin 25 mg/m2 iv d2-4 Frequency every 28 days Total cycles 4
Bortezomib
Bortezomib IV
Gemcitabine
Gemcitabine IV
Dexamethasone
Dexamethasone IV
Cisplatin
Cisplatin IV
Interventions
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Bortezomib
Bortezomib IV
Gemcitabine
Gemcitabine IV
Dexamethasone
Dexamethasone IV
Cisplatin
Cisplatin IV
Eligibility Criteria
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Inclusion Criteria
2. No history of stem cell transplantation, and no intention for stem cell transplantation.
3. Age between 16-75.
4. ECOG\<3.
5. At least 1 measurable tumor mass.
6. Minimum life expectancy of 3 months.
7. Written informed consent.
8. No uncontrolled CNS involvement by lymphoma:No CNS disease at time of relapse;CNS disease diagnosed at initial presentation allowed provided a complete response for CNS disease was achieved and maintained.
Exclusion Criteria
2. Clinically significant active infection.
3. Impaired liver, renal or other organ function not caused by lymphoma, which will interfere with the treatment schedule.
4. Any significant medical or psychiatric condition that might prevent the patient from complying with all study procedures.
5. Subject has ≥grade 2 peripheral neuropathy or grade 1 with pain within 14 days before enrollment.
6. Patients who are pregnant or breast-feeding.
7. HIV infection.
16 Years
75 Years
ALL
No
Sponsors
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Ruijin Hospital
OTHER
Responsible Party
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Zhao Weili
Professor
Principal Investigators
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Weili Zhao, Prof
Role: PRINCIPAL_INVESTIGATOR
Ruijin Hospital
Locations
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Ruijin Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Pengpeng XU, MD
Role: primary
Other Identifiers
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V-GDP
Identifier Type: -
Identifier Source: org_study_id