Leukemia Clinical Trial
Official title:
S0910, A Phase II Study of Epratuzumab (NSC-716711) in Combination With Cytarabine and Clofarabine for Patients With Relapsed or Refractory Ph- Negative Precursor B-Cell Acute Lymphoblastic Leukemia
RATIONALE: Monoclonal antibodies, such as epratuzumab, 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. Drugs used in chemotherapy, such
as cytarabine and clofarabine, work in different ways to stop the growth of cancer cells,
either by killing the cells or by stopping them from dividing. Giving epratuzumab together
with cytarabine and clofarabine may kill more cancer cells.
PURPOSE: This phase II trial is studying the side effects and how well giving epratuzumab
together with cytarabine and clofarabine works in treating patients with relapsed or
refractory acute lymphoblastic leukemia.
OBJECTIVES:
- To test whether the complete remission (CR) rate (CR and incomplete CR) in adult
patients with relapsed or refractory precursor B-cell acute lymphoblastic leukemia is
sufficiently high after treatment with cytarabine, clofarabine, and epratuzumab to
warrant further investigation.
- To estimate the frequency and severity of toxicities associated with the dosing schedule
of cytarabine, clofarabine, and epratuzumab used in this study.
- To investigate, preliminarily, the effect of laboratory correlates (minimal
post-treatment residual disease) and cytogenetic factors on prognosis in this patient
population. (Not reported here due to limited MRD data)
OUTLINE: This is a multicenter study.
Patients receive cytarabine IV over 2 hours on days 1-5, clofarabine IV over 1 hour on days
2-6, and epratuzumab IV over at least 1 hour on days 7, 14, 21, and 28 in the absence of
disease progression or unacceptable toxicity*.
NOTE: * Prophylactic intrathecal methotrexate is required for patients < 22 years of age, and
is recommended (but not required) for patients ≥ 22 years of age.
Blood samples, bone marrow samples, and/or tumor tissue samples may be collected for further
laboratory analysis.
Patients are followed up every 3 months for 2 years, then annually for 3 years (until 5 years
after registration).
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