{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"30"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"24"}],"units":"Participants"}],"description":"The maximum tolerated dose is defined as the highest alemtuzumab dose at which less than 40% of patients develop the dose limiting toxicity (DLT), where DLT is defined as the inability to proceed (due to medical complications) with the protocol treatment within six weeks of receiving the last dose of alemtuzumab. Groups of six patients will be enrolled into each cohort at the time of re-registration prior to starting Course IV. After a cohort has accrued 6 patients and at least 3 have completed the 2-6 week post alemtuzumab observation period without DLT, the incoming patients will be assigned to the next cohort in the table while the DLT and other toxicities continue to be assessed for the newly closed cohort. If less than 3 out of 6 enrolled patients in a cohort have completed the 2-6 week post alemtuzumab observation period without DLT, additional patients may continue to enroll in that same cohort, i.e., accrual will not be suspended while waiting for patient follow-up data.","groups":[{"description":"See detailed description or participant flow.","id":"OG000","title":"Phase I - Alemtuzumab and Combination Chemotherapy"}],"paramType":"NUMBER","populationDescription":"Only participants who started Alemtuzumab were analyzed per study design. Specifically, one patient declined Alemtuzumab and was excluded from this analysis.","reportingStatus":"POSTED","timeFrame":"6 weeks","title":"Maximum Tolerated Dose (MTD) of Alemtuzumab (Phase I)","type":"PRIMARY","unitOfMeasure":"mg"}