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

• Status: Completed
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York Medical College
• Collaborator: Genzyme, a Sanofi Company
• Treatments: Clofarabine

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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