A Study of Children With Refractory or Relapsed Acute Lymphoblastic Leukemia (ALLR16)

NCT00187083 Phase 3 COMPLETED

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)

Details

Lead sponsor	St. Jude Children's Research Hospital
Phase	Phase 3
Status	COMPLETED
Enrolment	40
Start date	1997-02
Completion	2003-12

Conditions

• Acute Lymphoblastic Leukemia

Interventions

• Topotecan, dexamethasone, vincristine
• E. coli Asparaginase, PEG-L-asparaginase
• erwinia asparaginase
• fludarabine, methotrexate, mercaptopurine
• idarubicin, etoposide, cytarbine, teniposide
• chemotherapy, intrathecal chemotherapy, steroid therapy

Primary outcomes

• 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. — December 2003

Countries

United States