Clinical trial · Interventional
Allogeneic Stem Cell Transplant With Clofarabine, Ara-C and TBI for AML and ALL
Clofarabine in Combination With Cytarabine and Total Body Irradiation Followed by Allogeneic Stem Cell Transplantation in Children With Acute Lymphoblastic Leukemia and Acute Non-Lymphoblastic Leukemia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Acute Myelogenous Leukemia | Acute Myeloid Leukemia | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Clofarabine | Drug | Clofarabine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Part A
- description
- Part A will be the dose escalation phase to determine the MTD and/or safe/tolerated dose of clofarabine.
- interventionNames
- Drug: Clofarabine
- type
- EXPERIMENTAL
- label
- Part B
- description
- Part B will accrue patients to further define the event free, disease free and overall survival at the MTD or safe/tolerated dose of clofarabine.
- interventionNames
- Drug: Clofarabine
Primary outcomes (3)
- measure
- To determine the maximum tolerated dose (MTD) and/or the safe, tolerated dose of clofarabine in combination with ARA-C and TBI followed by AlloSCT in children with ALL and ANLL.
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 30 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available