Acute Myeloid Leukemia Clinical Trial
Official title:
A Randomized Phase III Study of the Treatment of Children and Adolescents With Refractory or Relapsed Acute Myeloid Leukemia
Verified date | April 2011 |
Source | Dutch Childhood Oncology Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
This is an international multicenter open label randomized phase III trial in children with relapsed and refractory acute myeloid leukemia (AML) such a disease. The main purpose of this study is to determine the efficacy and toxicity of liposomal daunorubicin when added to fludarabine, ara-C and G-CSF(FLAG) in children with relapsed and refractory AML.
Status | Completed |
Enrollment | 394 |
Est. completion date | September 2010 |
Est. primary completion date | April 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 18 Years |
Eligibility |
Inclusion Criteria: - Children and adolescents less than eighteen years of age at start of chemotherapy. - Subject has one of the following: Primary refractory AML, first relapsed AML, second or subsequent relapsed AML and was not previously treated according to this particular protocol - Subjects with a combined relapse, or an isolated extramedullary relapse, or a bone marrow relapse are eligible, also for randomization. Exclusion Criteria: - Symptomatic cardiac dysfunction. - Inadequate performance score. - Any other organ dysfunction that will interfere with the administration of the therapy. - FAB type M3 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | St. Jude Children's Research Hospital | Memphis | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Dutch Childhood Oncology Group | International BFM Study Group, St. Jude Children's Research Hospital |
United States,
Kaspers J, Zimmermann M, Fleischhack G, Tamminga R, Gibson B, Armendariz H, Dworzak M, Ha S, Hovi L, Maschan A, Philippe N, Razzouk B, Rizzari C, Smisek P, Smith O, Stark B, Will A, Creutzig U. Relapsed Acute Myeloid Leukemia in Children and Adolescents:
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Response Rate | 8-9 years | No | |
Secondary | Toxicity between two arms | 8-9 years | Yes |
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