Phase 2 N=40 Treatment

Therapy for Pediatric Relapsed or Refractory Acute Lymphoblastic Leukemia

Acute Lymphoblastic Leukemia · Lymphoma, Lymphoblastic

Bottom Line

View on ClinicalTrials.gov: NCT00186875 ↗

Enrolled (actual)

Serious AEs

20.0%

Results posted

Dec 2013

Primary outcome: Primary: Response Rate — 0.846; 0.786; 0.154; 0.214 proportion of participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Etoposide, cytarabine, vincristine, dexamethasone (Drug); methotrexate, teniposide, PEG-asparaginase (Drug); mitoxantrone, cyclophosphamide, mercaptopurine, vinblastine (Drug); L-asparaginase, erwinia asparaginase (Drug); chemotherapy, intrathecal chemotherapy, steroid therapy (Procedure); Hematopoietic Stem Cell Transplant (Procedure); Natural Killer (NK) Cell Transplant (Procedure)
Age: Pediatric, Adult
Sex: All
Sponsor: St. Jude Children's Research Hospital
Primary completion: Aug 2016

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	—

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.

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

View full record on ClinicalTrials.gov →

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.