Clinical trial · Interventional
Combination Chemotherapy in Treating Young Patients With Relapsed or Refractory Acute Leukemia
A Phase I Dose Escalation Trial of Clofarabine in Addition to Topotecan, Vinorelbine, Thiotepa, and Dexamethasone in Pediatric Patients With Relapsed or Refractory Acute 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)
RATIONALE: Drugs used in chemotherapy, such as clofarabine, topotecan, vinorelbine, thiotepa, and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. PURPOSE: This phase I trial is studying the side effects and best dose of clofarabine when given together with topotecan, vinorelbine, thiotepa, and dexamethasone in treating young patients with relapsed or refractory acute leukemia.
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 |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| clofarabine | Drug | Clofarabine | ALIAS |
| dexamethasone | Drug | Dexamethasone | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| thiotepa | Drug | Thiotepa | ALIAS |
| topotecan hydrochloride | Drug | Topotecan | ALIAS |
| vinorelbine tartrate | Drug | Vinorelbine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Clofarabine
- description
- This is a single arm phase I clinical trial to assess safety (morbidity and mortality) of a novel leukemia re-induction regimen. The first component of this trial is a phase I dose escalation study to determine the maximum tolerated dose (MTD) of the novel agent Clofarabine, when used in combination with topotecan, vinorelbine, thiotepa and dexamethasone. A total of three dose levels will be explored in this study.
- interventionNames
- Biological: filgrastim
- Drug: clofarabine
- Drug: dexamethasone
- Drug: thiotepa
- Drug: topotecan hydrochloride
- Drug: vinorelbine tartrate
Primary outcomes (3)
- measure
- Maximum tolerated dose of clofarabine
- timeFrame
- 2 years
- measure
- Overall survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 28 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Must have 1 of the following diagnoses:
* Acute lymphoblastic leukemia (ALL) meeting 1 of the following criteria:
* Refractory to initial induction with two or more standard regimens
* Relapsed \< 24 months after first complete response on a high-risk protocol OR refractory to one standard reinduction regimen
* Second or greater relapse
* Acute myeloid leukemia, acute biphenotypic leukemia, or acute undifferentiated leukemia meeting 1 of the following criteria:
* Refractory to initial induction
* First or greater relapse
* Must have \> 20% bone marrow blasts, or evidence of recurrent disease at an extramedullary site
* No symptomatic CNS disease
* Patients with asymptomatic CNS disease are eligible with the approval of the principal investigator
PATIENT CHARACTERISTICS:
* Karnofsky performance status (PS) 70-100% OR Lansky PS 70-100%
* AST and ALT \< 4 times upper limit of normal
* Bilirubin \< 2.0 mg/dL (unless liver involvement)
* Creatinine within normal range for age OR creatinine clearance \> 60 mL/min/1.73 m\^2
* Adequate cardiac function (either asymptomatic with no prior risk factors, or if symptomatic, left ventricular ejection fraction \> 50% at rest)
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No active uncontrolled viral, bacterial, or fungal infection
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No prior clofarabine
* More than 2 weeks since prior systemic chemotherapy
* At least 7 days since prior chemotherapy for patients with rapidly progressive disease and recoveredReferences
Publications (0)
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