Trial of Bortezomib, Cytarabine, and Dexamethasone in Mantle Cell Lymphoma

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 2 Trial to Evaluate the Efficacy of Bortezomib, Cytarabine, and Dexamethasone in Patients With Relapsed or Refractory Mantle Cell Lymphoma

Conditions
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Mantle Cell Lymphoma

Intervention / Treatment
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* Drug: Bortezomib, Cytarabine, Dexamethasone, Pegteograstim


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Bortezomib, Cytarabine, Dexamethasone, Pegteograstim | Drug: Bortezomib, Cytarabine, Dexamethasone, Pegteograstim<br>* 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<br>* Other names: Protezomib, Cytarabine, Dexamethasone, Neulapeg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response | Lugano classification | within 28 days after the last cycle of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete response | Lugano classification | within 28 days after the last cycle of treatment | 
| Overall survival | Interval from registration to death from any cause | 5 years | 
| Progression-free survival | Interval from registration to progression or death from any cause | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mantle cell lymphoma, Bortezomib, Cytarabine