A Nonrandomized Dose-escalation Study of Clofarabine in Combination With Gemtuzumab Ozogamicin for Relapsed/Refractory Acute Myeloid Leukemia (AML) for Patients Less Than 60 Years-old
- Identify the maximum tolerated dose and dose-limiting toxicities of clofarabine when
administered with gemtuzumab ozogamicin in patients with refractory acute myeloid
leukemia (AML) or with AML that has relapsed within 1 year after cytarabine-containing
- Estimate the rates of complete response and/or partial complete response with
incomplete platelet recovery in patients treated with this regimen.
- Estimate the duration of remission in patients treated with this regimen and not
proceeding to high-dose therapy and allogeneic stem cell transplantation.
- Estimate the frequency with which patients enrolled on this study proceed to allogeneic
or autologous blood or bone marrow stem cell transplantation.
OUTLINE: This is a dose-escalation study of clofarabine.
Patients receive induction therapy comprising clofarabine IV on days 1-5 and gemtuzumab
ozogamicin IV over 2 hours on days 1, 4, and 7 during course 1 only. Beginning in course 2,
after blood counts recover, patients receive consolidation therapy comprising clofarabine IV
on days 1-5. Consolidation treatment repeats upon blood count recovery for up to 2 courses
in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients in remission after consolidation therapy are
followed monthly for the first 6 months, and then every 3-4 months for 2 years.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose of clofarabine
Thomas C. Shea, MD
UNC Lineberger Comprehensive Cancer Center
United States: Institutional Review Board
|Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill||Chapel Hill, North Carolina 27599-7570|