Clinical trial NCT02840539: Trial of Bortezomib, Cytarabine, and Dexamethasone in Mantle Cell Lymphoma
Official title: A Phase 2 Trial to Evaluate the Efficacy of Bortezomib, Cytarabine, and Dexamethasone in Patients With Relapsed or Refractory Mantle Cell Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Mantle Cell Lymphoma
Keywords: Mantle cell lymphoma
Bortezomib
Cytarabine
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Consortium for Improving Survival of Lymphoma
First posted: 2016-07-21
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Overall response
timeFrame: within 28 days after the last cycle of treatment
Secondary outcomes:
measure: Complete response
timeFrame: within 28 days after the last cycle of treatment
measure: Overall survival
timeFrame: 5 years
measure: Progression-free survival
timeFrame: 5 years
Other outcomes:
measure: Quality of life
timeFrame: within 28 days after the last cycle of treatment
measure: Toxicity
timeFrame: within 28 days after the last cycle of treatment
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Youngil Koh, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.