Trial of Bortezomib, Cytarabine, and Dexamethasone in Mantle Cell Lymphoma
NCT ID: NCT02840539
Last Updated: 2023-03-20
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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COMPLETED
PHASE2
19 participants
INTERVENTIONAL
2016-10-11
2022-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Experimental
Bortezomib, Cytarabine, Dexamethasone, Pegteograstim
Bortezomib, Cytarabine, Dexamethasone, Pegteograstim
Bortezomib: 1.3mg/m2 per day, SC (mixed with normal saline 1.4ml) on day 1, 4, 8, and 11 of each 28-day cycle
Cytarabine: 1.5g/m2 per day, IV (in the vein) over 3 hours on day 2 and 3 of each 28-day cycle for subjects aged less than 65 and 1g/m2 with the same route and schedule for those aged 65 or older
Dexamethasone: 20mg per day, IV (in the vein) or PO on day 1, 4, 8, and 11 of each 28-day cycle
Pegfilgrastim: 6mg once, SC on day 13 of each 28-day cycle Number of cycles: 6 unless progression or unacceptable toxicity develops within 6 cycles
Interventions
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Bortezomib, Cytarabine, Dexamethasone, Pegteograstim
Bortezomib: 1.3mg/m2 per day, SC (mixed with normal saline 1.4ml) on day 1, 4, 8, and 11 of each 28-day cycle
Cytarabine: 1.5g/m2 per day, IV (in the vein) over 3 hours on day 2 and 3 of each 28-day cycle for subjects aged less than 65 and 1g/m2 with the same route and schedule for those aged 65 or older
Dexamethasone: 20mg per day, IV (in the vein) or PO on day 1, 4, 8, and 11 of each 28-day cycle
Pegfilgrastim: 6mg once, SC on day 13 of each 28-day cycle Number of cycles: 6 unless progression or unacceptable toxicity develops within 6 cycles
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Consortium for Improving Survival of Lymphoma
OTHER
Seoul National University Hospital
OTHER
Responsible Party
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YOUNGIL KOH
Associate Professor
Principal Investigators
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Youngil Koh, MD
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
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Seoul National University Hospital
Seoul, , South Korea
Countries
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References
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Robak T, Huang H, Jin J, Zhu J, Liu T, Samoilova O, Pylypenko H, Verhoef G, Siritanaratkul N, Osmanov E, Alexeeva J, Pereira J, Drach J, Mayer J, Hong X, Okamoto R, Pei L, Rooney B, van de Velde H, Cavalli F; LYM-3002 Investigators. Bortezomib-based therapy for newly diagnosed mantle-cell lymphoma. N Engl J Med. 2015 Mar 5;372(10):944-53. doi: 10.1056/NEJMoa1412096.
Shin J, Lee JY, Lee GW, Kim WS, Park Y, Do YR, Kim DS, Kim KH, Choi YS, Byun JM, Hong J, Kim I, Yoon SS, Koh Y. Phase II study of bortezomib, cytarabine and dexamethasone in relapsed or refractory mantle cell lymphoma. Br J Haematol. 2023 Sep;202(6):e54-e57. doi: 10.1111/bjh.18965. Epub 2023 Jul 5. No abstract available.
Other Identifiers
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SNUH-1602-153-747
Identifier Type: -
Identifier Source: org_study_id
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