Spots Global Cancer Trial Database for Clofarabine With Cytarabine for Patients With Minimal Residual Disease Positive Leukemia

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Trial Identification

Brief Title: Clofarabine With Cytarabine for Patients With Minimal Residual Disease Positive Leukemia

Official Title: Clofarabine With Cytarabine for MRD Positive Leukemia

Study ID: NCT01158885

Conditions

Minimal Residual Disease

Leukemia, Lymphoblastic, Acute

Leukemia, Myelogenous, Acute

Interventions

Clofarabine

Cytarabine intravenous

Methotrexate

Intrathecal (IT) Cytarabine

Study Description

Brief Summary: This study will test the ability of clofarabine + cytarabine to eliminate minimal residual disease (MRD) in acute myelogenous leukemia (AML) and acute lymphoblastic leukemia (ALL) patients whose bone marrows exhibit complete remission by morphology. The toxicity profile of this regimen will be evaluated in addition to toxicity experienced by patients who proceed to stem cell transplant. Overall length of remission will also be collected.

Detailed Description: Recent studies have demonstrated that even low levels of minimum residual disease (MRD) (\>0.01% abnormal blasts) after aggressive re-induction therapy indicate a relatively poor outcome in relapsed acute lymphoblastic leukemia (ALL) patients, including those who proceed to allogeneic stem cell transplant (alloSCT). A similarly poor prognosis was seen in pediatric acute myelogenous leukemia patients with sub-morphologic disease prior to alloSCT. Studies to identify therapies that can eliminate persistent leukemia, have low toxicity profiles and can serve as a bridge to transplant are needed. This study will test the ability of clofarabine + cytarabine to eliminate minimal residual disease (MRD) in acute myelogenous leukemia and acute lymphoblastic leukemia patients whose bone marrows exhibit complete remission by morphology. The toxicity profile of this regimen will be evaluated in addition to toxicity experienced by patients who proceed to stem cell transplant. Overall length of remission will also be collected.