Mantle Cell Lymphoma
Conditions
Keywords
Mantle cell lymphoma, Bortezomib, Cytarabine
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.
Interventions
DRUGBortezomib, 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
Sponsors
Consortium for Improving Survival of Lymphoma
Seoul National University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall response | within 28 days after the last cycle of treatment | Lugano classification |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complete response | within 28 days after the last cycle of treatment | Lugano classification |
| Overall survival | 5 years | Interval from registration to death from any cause |
| Progression-free survival | 5 years | Interval from registration to progression or death from any cause |
Other
| Measure | Time frame | Description |
|---|---|---|
| Quality of life | within 28 days after the last cycle of treatment | EORTC QLQ-C30 |
| Toxicity | within 28 days after the last cycle of treatment | NCI CTCAE version 4.03 |
Countries
South Korea
Outcome results
None listed