Therapy for Pediatric Relapsed or Refractory Acute Lymphoblastic Leukemia - Full Text View

Sponsor:	St. Jude Children's Research Hospital
Information provided by (Responsible Party):	St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:	NCT00186875

Purpose

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.

Condition	Intervention	Phase
Acute Lymphoblastic Leukemia Lymphoma, Lymphoblastic	Drug: Etoposide, cytarabine, vincristine, dexamethasone Drug: methotrexate, teniposide, PEG-asparaginase Drug: mitoxantrone, cyclophosphamide, mercaptopurine, vinblastine Drug: L-asparaginase, erwinia asparaginase Procedure: chemotherapy, intrathecal chemotherapy, steroid therapy Procedure: Hematopoietic Stem Cell Transplant Procedure: Natural Killer (NK) Cell Transplant	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Study of Therapy for Pediatric Relapsed or Refractory Acute Lymphoblastic Leukemia

Resource links provided by NLM:

MedlinePlus related topics: Acute Lymphocytic Leukemia Chronic Lymphocytic Leukemia Leukemia Lymphoma

Drug Information available for: Dexamethasone Cyclophosphamide 6-Mercaptopurine Vincristine Methotrexate Cytarabine hydrochloride Teniposide Etoposide Dexamethasone acetate Mitoxantrone Mitoxantrone hydrochloride Doxiproct plus Etoposide phosphate Pegaspargase Vinblastine sulfate Cytarabine Vinblastine Dexamethasone Sodium Phosphate Vincristine sulfate Mercaptopurine L-Asparaginase

U.S. FDA Resources

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

Primary Outcome Measures:

To estimate the response rate and toxicities of an etoposide and teniposide based induction regimen for patients with refractory or relapsed ALL [ Time Frame: Duration of induction, 29 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	47
Study Start Date:	November 2003
Estimated Study Completion Date:	November 2012
Estimated Primary Completion Date:	November 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1	Drug: Etoposide, cytarabine, vincristine, dexamethasone See Detailed Description section for details of treatment interventions. Drug: methotrexate, teniposide, PEG-asparaginase See Detailed Description section for details of treatment interventions. Drug: mitoxantrone, cyclophosphamide, mercaptopurine, vinblastine See Detailed Description section for details of treatment interventions. Drug: L-asparaginase, erwinia asparaginase See Detailed Description section for details of treatment interventions. Procedure: chemotherapy, intrathecal chemotherapy, steroid therapy See Detailed Description section for details of treatment interventions. Procedure: Hematopoietic Stem Cell Transplant See Detailed Description section for details of treatment interventions. Procedure: Natural Killer (NK) Cell Transplant See Detailed Description section for details of treatment interventions.

Arms

Assigned Interventions

1

Drug: Etoposide, cytarabine, vincristine, dexamethasone