Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
ImmunoGen, Inc.
OBJECTIVES: Primary * Determine the safety and tolerability of BB-10901 * Determine the maximum tolerated dose of this drug in these patients. Secondary * Determine the pharmacokinetics of this drug in these patients. * Determine the efficacy of this drug in these patients. OUTLINE: This is an open-label, multicenter, dose-escalation study. Patients receive BB-10901 IV over 40 minutes once daily on days 1-3.\* Treatment repeats every 21 days NOTE: \*Patients who do not tolerate 3 consecutive daily infusions of BB-10901 may receive infusions of BB-10901 on 3 alternate days, upon approval by the investigator and/or the independent Safety Review Board. Cohorts of 4-6 patients receive escalating doses of BB-10901 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 4-6 patients experience dose-limiting toxicity in course 1. Up to 40 patients are treated at the MTD. After completion of study treatment, patients are followed for short term and long term follow up and survival. PROJECTED ACCRUAL: Approximately 100 patients will be accrued to this study.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
