Seoul National University Hospital
Seoul, 03080, South Korea
NCT Number: NCT02840539
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 2
Seoul, 03080, South Korea
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 names: Protezomib, Cytarabine, Dexamethasone, Neulapeg
Time frame: within 28 days after the last cycle of treatment
Lugano classification
Time frame: within 28 days after the last cycle of treatment
Lugano classification
Time frame: 5 years
Interval from registration to death from any cause
Time frame: 5 years
Interval from registration to progression or death from any cause
Time frame: within 28 days after the last cycle of treatment
EORTC QLQ-C30
Time frame: within 28 days after the last cycle of treatment
NCI CTCAE version 4.03
Seoul National University Hospital
Other
A Phase 2 Trial to Evaluate the Efficacy of Bortezomib, Cytarabine, and Dexamethasone in Patients With Relapsed or Refractory Mantle Cell Lymphoma
Acronym: BATMAN
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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