Clinical trial · Interventional
Clove In The Treatment Of Relapsed Or Resistant Acute Leukemia In Children
Clofarabine, Cyclophosfamide, And Etoposide For The Treatment Of Relapsed Or Resistant Acute Leukemia In Pediatric Patients
- 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)
Study Hypothesis. combination chemotherapy with Clofarabine VP16 and Cyclophosphamide is able to induce remission in resistant/refractory acute leukemias in pediatric. Forty children with relapsed or refractory Acute Lymphoblastic Leukemia (ALL) or Acute Myeloid Leukemia (AML) entered the study and received the association of clofarabine (40 mg/m2/day) in combination with etoposide (100 mg/m2/day) and Cyclophosphamide (440 mg/m2/day) in 1 or 2 induction cycles End point were complete remission (CR)or CR without platelet recovery (CRp) and toxicity
Conditions
Conditions (1)
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 Leukemia | Acute Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Clofarabine VP 16 ciclophospahamide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- children with advanced leukemia
- interventionNames
- Drug: Clofarabine VP 16 ciclophospahamide
Primary outcomes (1)
- measure
- response to treatment
- timeFrame
- after an expected average of 3 weeks after the first dose of each chemotherapy course
Secondary outcomes (1)
- measure
- Number of patients with toxicity as a measure of safety and tolerability
- timeFrame
- at an expected average of 4 weeks after the first dose of each chemotherapy course
- description
- Grade of toxicity defined according to the National Cancer's Inst. Common terminology Criteria (NCI CTCAE v3.0)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Month
- Maximum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * presence of \> 25% of blast in bone marrow * treatment with second line therapies * patients with resistant disease i.e. with \>25% of blasts 21 days after the last cytostatic agent administration * children with persistent high MRD level (\> 10-3) after first or further line chemotherapy, were considered eligible to the treatment * Relapsed after \> months after SCT * Karnofsky score \>50 * a Forced Espiratory Volume \>30% * sufficient hepatic and renal function defined as creatinine levels \<2 × ULN, bilirubin \<1.5 × ULN * aspartate and alanine aminotransferases \<10 × ULN. Exclusion Criteria: * isolated extra-medullary relapse, and active infections
References
Publications (0)
Data not yet available