CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 47 enrolled
Drug / intervention
Etoposide, cytarabine, vincristine, dexamethasone +6 moredrug
Likely dose
Not stated in record
Key inclusion· 2
  • Childhood ALL in first relapse OR first hematological relapse after extramedullary relapse OR failure to achieve complete remission with frontline therapy OR lymphoblastic leukemia in first relapse
  • Age ≤21 years
Key exclusion· 2
  • Life expectancy less than 8 weeks
  • Mature B cell ALL

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00186875
NCT00186875Phase 2Completed

A Study of Therapy for Pediatric Relapsed or Refractory Acute Lymphoblastic Leukemia

St. Jude Children's Research Hospital·interventional·Posted Sep 16, 2005·Updated Jul 28, 2017

In Brief

A Phase 2 clinical trial evaluating Etoposide, cytarabine, vincristine, dexamethasone, methotrexate, teniposide, PEG-asparaginase, and 5 other interventions for Acute Lymphoblastic Leukemia and Lymphoma, Lymphoblastic. Completed, enrolled 47 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 16, 2005
Enrollment StartNov 1, 2003
Primary CompletionAug 1, 2016
TodayJul 2, 2026
Enrollment to primary: 12.8 yearsPosted 20.8 years ago

Interventions

Etoposide, cytarabine, vincristine, dexamethasonedrug

See Detailed Description section for details of treatment interventions.

methotrexate, teniposide, PEG-asparaginasedrug

See Detailed Description section for details of treatment interventions.

mitoxantrone, cyclophosphamide, mercaptopurine, vinblastinedrug

See Detailed Description section for details of treatment interventions.

L-asparaginase, erwinia asparaginasedrug

See Detailed Description section for details of treatment interventions.

chemotherapy, intrathecal chemotherapy, steroid therapyprocedure

See Detailed Description section for details of treatment interventions.

Hematopoietic Stem Cell Transplantprocedure

See Detailed Description section for details of treatment interventions.

Natural Killer (NK) Cell Transplantprocedure

See Detailed Description section for details of treatment interventions.