Count of number of participants who responded with a Complete Response (complete disappearance of all detectable clinical and radiological evidence of disease) at week 8 and again clinically and radiologically confirmed at week 12.

Intent to treat population

Count of the number of participants who experienced treatment emergent adverse events (TEAEs). TEAEs occurred during the time study intervention was being taken occurring on or after Day 1 and no longer than 30 days after the last dose of study medication.

Safety population

Count of participants' best response within categories defined by the International Working Group (IWG):

> Complete Response (complete disappearance of detectable clinical and radiological evidence of disease),

> Complete Response Unconfirmed (unconfirmed complete disappearance),

> Partial Response (>=50% decrease sum of the product of the greatest diameters in the six largest dominant nodes or nodal masses),

> Stable Disease (neither response nor disease progression),

> Progression (new lesion or increase by 50% of previously involved sites from nadir).

Intent to treat population

Time to event was measured from the date of randomization to the date of first progressive disease (PD) or death.

Intent to treat population

Count of days in which a participant experiences a Partial Response (>=50% decrease sum of the product of the greatest diameters in the six largest dominant nodes or nodal masses) or better. Time to event was measured from the date of response to the date of progressive disease (PD) or death.

Intent to treat population.

A cost-effectiveness analysis from the payer perspective was to be performed. Only direct medical costs for each patient during the study period were to be included for analysis. Costs were to be calculated by multiplying each health care resource unit by the amount reimbursed by a payer. Health care resource utilization units are a way to normalize the quantity of health care provided to each participant so that costs can be compared.

No participants were analyzed because the study was terminated early due to low enrollment.