NCT01158885

Clofarabine With Cytarabine for Patients With Minimal Residual Disease Positive Leukemia

Clofarabine With Cytarabine for MRD Positive Leukemia

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Therapeutic Advances in Childhood Leukemia Consortium · Academic / Other
• Sex: All
• Age: 1 Year – 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Minimal Residual Disease
• Leukemia, Lymphoblastic, Acute
• Leukemia, Myelogenous, Acute

Interventions

Type	Name	Description
DRUG	Clofarabine	20 mg/m2/day intravenously (IV) over 2 hours (given at hours 0 to 2) on days 1 through 5.
DRUG	Cytarabine intravenous	1 gram/m2/day intravenously (IV) over 2 hours to be given 4 hours after the initiation of clofarabine on days 1 through 5.
DRUG	Methotrexate	Methotrexate to be given intrathecally (IT) to all acute lymphoblastic leukemia (ALL) patients on day 1 at the dose defined by age below: * 8 mg for patients age 1-1.99 * 10 mg for patients age 2-2.99 * 12 mg for patients 3-8.99 years of age * 15 mg for patients \>9 years of age
DRUG	Intrathecal (IT) Cytarabine	Intrathecal (IT) cytarabine is optional for acute myelogenous leukemia (AML) patients. If intrathecal cytarabine is to be given, it must be given at least 72 hours but not more than 7 days prior to the initiation of intravenous cytarabine. Dose should be given according to age as defined below: * 30 mg for patients age 1-1.99 * 50 mg for patients age 2-2.99 * 70 mg for patients \>3 years of age

Timeline

• Start date: 2010-08-01
• Primary completion: 2012-10-24
• Completion: 2012-10-24
• First posted: 2010-07-08
• Last updated: 2021-10-26
• Results posted: 2019-10-07

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study