The primary objective of this study is to assess objective response rate (ORR) in patients with relapsed or refractory MCL who failed ibrutinib treatment or were unable to tolerate ibrutinib.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
4
Starting dose 60 mg (dose reduction due to toxicities to 45 mg allowed). Administered in slow IV bolus on days 1, 8 and 15 of each 28 day cycle until disease progression or until another criterion is met for withdrawal from study treatment.
Unnamed facility
Baltimore, Maryland, United States
Unnamed facility
Hackensack, New Jersey, United States
Unnamed facility
New York, New York, United States
Unnamed facility
New York, New York, United States
Unnamed facility
Objective response rate (ORR)
ORR is defined as the proportion of patients who have a best overall response of complete response (CR) or partial response (PR) during study conduct according to the criteria defined by the Lugano response criteria in NHL 2014.
Time frame: 24 weeks
Complete response rate (CRR)
Defined as the proportion of patients who have a best overall response of CR during study conduct according to the criteria defined by the Lugano response criteria in NHL 2014
Time frame: 24 weeks
Disease control rate (DCR)
Defined as the proportion of patients who have a best response of CR, PR, or stable disease (SD)
Time frame: 24 weeks
Progression-free survival (PFS)
Defined as the time (in days) from the date of first administration of study treatment to radiological disease progression or death from any cause (if death occurs before radiological progression is documented). PFS for patients without radiological progression or death at the time of analysis will be censored at the last date of evaluable tumor assessment. PFS for alive patients who have no tumor assessments after baseline will be censored at day 1.
Time frame: 24 weeks
Duration of response (DOR)
Defined as the time (in days) from the date of first observed tumor response of CR or PR, whichever was noted earlier, to radiological disease progression or death from any cause (if death occurs before radiological progression is documented)
Time frame: 24 weeks
Overall survival (OS)
Defined as the time (in days) from the date of first administration of study treatment to death from any cause. The OS time for patients alive at the time of analysis will be censored at their last known alive date.
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Burlington, Vermont, United States
Time frame: 24 weeks
Number of participants with treatment emergent adverse events (TEAEs) as a measure of safety and tolerability
Time frame: Approximately 7 months