Trial of Bortezomib Cytarabine and Dexamethasone in Mantle Cell Lymphoma

  • STATUS
    Recruiting
  • End date
    Jun 21, 2025
  • participants needed
    32
  • sponsor
    Seoul National University Hospital
Updated on 21 January 2021
cytarabine
dexamethasone
neutrophil count
bortezomib
renal function tests
refractory mantle cell lymphoma

Summary

The purpose of this study is to determine whether bortezomib, cytarabine, and dexamethasone are effective in the treatment of relapsed or refractory mantle cell lymphoma after 1 to 3 lines of previous treatment.

Details
Condition Lymphoma, Mantle cell lymphoma, Non-Hodgkin's Lymphoma
Treatment Bortezomib, Cytarabine, Dexamethasone, Pegteograstim
Clinical Study IdentifierNCT02840539
SponsorSeoul National University Hospital
Last Modified on21 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Pathologically confirmed mantle cell lymphoma
Relapse or progression after 1-3 lines of previous chemotherapy with or without immunologic agents
ECOG performance status 2 or less
Adequate hematologic, hepatic, and renal function i. White blood cells 3,000 /ul ii. Absolute neutrophil count 1,000 /ul iii. Platelets 50,000 /ul iv. Hemoglobin 9.0 g/dL v. Total bilirubin < 2 times upper limit of normal vi. AST, ALT < 2.5 times upper limit of normal vii. Serum creatinine < 1.5 times upper limit of normal

Exclusion Criteria

Previously treated with 4 or more lines of chemotherapy with or without immunologic agents
Previously treated with bortezomib
Treated with a cytarabine-containing regimen as the last line and within 6 months before registration
Other cancer diagnosed within 5 years before registration
Uncontrolled symptomatic CNS involvement of mantle cell lymphoma
Uncontrolled systemic infection
Inherited immunodeficiency disease or AIDS
Pregnancy
Breast-feeding
Peripheral neuropathy of grade 3 or higher
Other health conditions considered to be inappropriate for this trial in the primary physician's opinion
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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