Leukemia Clinical Trial
Official title:
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
RATIONALE: Drugs used in chemotherapy, such as clofarabine, work in different ways to stop
the growth of cancer cells, either by killing the cells or by stopping them from dividing.
Monoclonal antibodies, such as gemtuzumab, can block cancer growth in different ways. Some
block the ability of cancer cells to grow and spread. Others find cancer cells and help kill
them or carry cancer-killing substances to them. Giving clofarabine together with gemtuzumab
may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of clofarabine when
given together with gemtuzumab in treating patients with relapsed or refractory acute
myeloid leukemia.
OBJECTIVES:
Primary
- 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
therapy.
Secondary
- 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.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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