Phase 2
Completed N=40
Therapy for Pediatric Relapsed or Refractory Acute Lymphoblastic Leukemia
Source: ClinicalTrials.gov NCT00186875 ↗Enrolled (actual)
40
Serious AEs
20.0%
Results posted
Dec 2013
Primary outcomePrimary: Response Rate — 0.846; 0.786; 0.154; 0.214 proportion of participants
Summary
The main purpose of this study is to find out how well participants with relapsed or refractory ALL respond to treatment with an etoposide- and teniposide-based induction chemotherapy regimen and what the side effects are.
Primary Objectives:
* To estimate the response rate for patients with refractory or relapsed ALL.
* To estimate the survival rate of patients with refractory or relapsed ALL treated with risk-directed therapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Response Rate |
0.846; 0.786; 0.154; 0.214 | — |
| PRIMARY Overall Survival (OS) |
0.654; 0.357 | — |
Eligibility Criteria
Inclusion Criteria
- Childhood ALL in first relapse OR in first hematological relapse after an extramedullary relapse, OR not attaining a complete remission with frontline therapies, OR lymphoblastic leukemia in first relapse.
- Patients must be 21 years of age or younger
- Informed consent explained to and signed by parent/legal guardian.
Exclusion Criteria
- Life expectancy less than 8 weeks
- Patients with mature B cell ALL
Data sourced from ClinicalTrials.gov (NCT00186875). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.