If found to be eligible to take part in this study, participants will be assigned to a study
group based on when joining the study. Up to 4 groups of up to 6 participants will be
enrolled in the Phase I portion of the study, and up to 53 participants will be enrolled in
If enrolled in the Phase I portion, the dose of Lintuzumab-Ac225 received will depend on
when participant joined this study. The first group of participants will receive the lowest
dose level of Lintuzumab-Ac225. Each new group will receive a higher dose of
Lintuzumab-Ac225 than the group before it, if no intolerable side effects were seen. This
will continue until the highest tolerable dose of Lintuzumab-Ac225 is found.
If enrolled in the Phase II portion, participant will receive Lintuzumab-Ac225 at the
highest dose that was tolerated in the Phase I portion.
All participants will receive the same dose level of cytarabine.
Study Drug Administration:
Participants will receive cytarabine as an injection under the skin. This is called a
subcutaneous injection. During the first office visit, participant or a caregiver will be
taught to give these injections at home. Participant will get cytarabine injections 2 times
each day during Days 1-10 of each study cycle. Cycle 1 may last up to 52 days and will
depend on how participant recovers from the Lintuzumab-Ac225. All other cycles will be 28
Participant will receive Lintuzumab-Ac225 by vein over 15-30 minutes at a time point about 4
to 7 days after your last dose of cytarabine in Cycle 1. Participant will receive it a
second time about 4 to 7 days after that.
One (1) day before the second dose of Lintuzumab-Ac225, participant will begin taking lasix
(furosemide) by mouth every day for 10 days. Furosemide is taken to prevent possible damage
to the kidneys.
One (1) day after last dose of furosemide, participant will begin taking spironolactone by
mouth every day for up to 1 year. It is also taken to prevent possible kidney damage.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum Tolerated Dose (MTD) of Lintuzumab-Ac225
Cycle 1, up to 52 days
Farhad Ravandi-Kashani, MD
UT MD Anderson Cancer Center
United States: Food and Drug Administration
|UT MD Anderson Cancer Center||Houston, Texas 77030|