Allogeneic Stem Cell Transplant With Clofarabine, Ara-C and TBI for AML and ALL

Completed · Phase 1/Phase 2

Conditions studied: Acute Lymphoblastic Leukemia, Acute Myelogenous Leukemia

In brief

Hypothesis: Myeloablative conditioning using a dose escalation of clofarabine in combination with cytarabine (ARA-C) and total body irradiation (TBI) will lead to improved survival for previously untransplanted children and adolescents with acute lymphoblastic leukemia (ALL) and acute non-lymphoblastic leukemia (ANLL)followed by allogeneic stem cell transplantation (AlloSCT).

Key facts

Study ID

NCT00529360

Run by

New York Medical College

People needed

32

Starts

2007-06-01

Expected to finish

2016-03-01

Last updated by the study team

2016-03-24

Who can join

Age: any, up to 30. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age: Patients must be <30 years of age.
• Disease Status: ALL in relapse, induction failure, CR3, or CR3P (Part A ONLY); AML in relapse, induction failure, CR3, or CR3P (Part A ONLY); ALL in CR3 or CR3P (Part A and Part B); AML in CR3 or CR3P (Part A and BONLY); CR3/CR3P must be documented by bone marrow and CNS assessment within 14 days of initiation of the pre-transplant conditioning regimen.
• Creatinine clearance >40 ml/min/m2 or >60 ml/min/1.73 m2 or an equivalent radioisotope glomerular filtration rate (GFR) as determined by the institutional normal range or serum creatinine based on age
• Adequate liver function defined as: Total bilirubin <2.5 mg/dl l, or SGOT (AST) or SGPT (ALT) <5 x upper limit of normal
• Adequate cardiac function defined as: Shortening fraction >27% by echocardiogram, or Ejection fraction of >50% by radionuclide angiogram or echocardiogram.
• Adequate pulmonary function defined as: Corrected DLCO >60% by pulmonary function test; For children who are uncooperative, no evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry >94% on room air.
• Performance Status: For patients age 1-16 years, Lansky score of >60; For patients > 16 years, Karnofsky score of >60.
• Patients must have received a minimum of one round of re-induction and one round of consolidation chemotherapy after relapse #2

You may not qualify if…

• Patients with prior myeloablative allogeneic stem cell transplantation and /or TBI.
• Females who are pregnant (positive HCG) or lactating.
• Karnofsky <60% or Lansky <60% if less than 16 years of age
• Age >30 years of age
• Any patient with uncontrolled infection prior to study entry
• Patients with evidence of active disease.
• Patients with Down syndrome are excluded

Where it is running

• New York Medical College — Vallhala, New York, United States

Full record on ClinicalTrials.gov

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