A Study of Children With Refractory or Relapsed ALL - Full Text View

Sponsored by:	St. Jude Children's Research Hospital
Information provided by:	St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:	NCT00187083

Purpose

The main purpose of this study is to find out which form of asparaginase (the native E. coli/Erwinia) or PEG-asparaginase) is more effective during induction treatment for children with acute lymphoblastic leukemia that has come back after treatment (relapsed) or is resistant to treatment (refractory)

Condition	Intervention	Phase
Acute Lymphoblastic Leukemia	Drug: Topotecan, dexamethasone, vincristine Drug: E. coli Asparaginase, PEG-L-asparaginase Drug: erwinia asparaginase Drug: fludarabine, methotrexate, mercaptopurine Drug: idarubicin, etoposide, cytarbine, teniposide Procedure: chemotherapy, intrathecal chemotherapy, steroid therapy	Phase III

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood

Drug Information available for: Dexamethasone 6-Mercaptopurine Vincristine Methotrexate Fludarabine Teniposide Etoposide Dexamethasone acetate Idarubicin Fludarabine monophosphate Doxiproct plus Topotecan Pegaspargase Dexamethasone Sodium Phosphate Vincristine sulfate Mercaptopurine L-Asparaginase

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Pharmacokinetics/Dynamics Study
Official Title:	A Study of Children With Refractory or Relapsed Acute Lymphoblastic Leukemia (ALLR16)

Further study details as provided by St. Jude Children's Research Hospital:

Primary Outcome Measures:

To compare in a randomized trial the depletion of asparagine in patients who receive the native form of asparaginase or PEG-asparaginase during induction therapy. [ Time Frame: December 2003 ] [ Designated as safety issue: Yes ]

Enrollment:	40
Study Start Date:	February 1997
Study Completion Date:	December 2003
Primary Completion Date:	December 2003 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Native asparaginase	Drug: Topotecan, dexamethasone, vincristine See Detailed Description section for details of treatment interventions. Drug: E. coli Asparaginase, PEG-L-asparaginase See Detailed Description section for details of treatment interventions. Drug: erwinia asparaginase See Detailed Description section for details of treatment interventions. Drug: fludarabine, methotrexate, mercaptopurine See Detailed Description section for details of treatment interventions. Drug: idarubicin, etoposide, cytarbine, teniposide See Detailed Description section for details of treatment interventions. Procedure: chemotherapy, intrathecal chemotherapy, steroid therapy See Detailed Description section for details of treatment interventions.
2: Experimental PEG-asparaginase	Drug: Topotecan, dexamethasone, vincristine See Detailed Description section for details of treatment interventions. Drug: E. coli Asparaginase, PEG-L-asparaginase See Detailed Description section for details of treatment interventions. Drug: erwinia asparaginase See Detailed Description section for details of treatment interventions. Drug: fludarabine, methotrexate, mercaptopurine See Detailed Description section for details of treatment interventions. Drug: idarubicin, etoposide, cytarbine, teniposide See Detailed Description section for details of treatment interventions. Procedure: chemotherapy, intrathecal chemotherapy, steroid therapy See Detailed Description section for details of treatment interventions.

Arms

Assigned Interventions

1: Experimental

Native asparaginase

Drug: Topotecan, dexamethasone, vincristine