University of Iowa Hospitals and Clinics

Clinical Trial Details

Short Title
Randomized Trial for Newly Diagnosed High Risk B-Precursor Acute Lymphoblastic Leukemia
Official Title

Randomized Trial for Newly Diagnosed High Risk B-Precursor Acute Lymphoblastic Leukemia

Description

AALL1131: A Phase III Randomized Trial for newly diagnosed high risk B-precursor acute lymphoblastic leukemia (ALL) testing clofarabine (IND 73789) in the very high risk stratum

Leukemia is cancer of blood cells. It develops in the bone marrow, which is the soft, spongy center of the bones that produces the three major blood cells: white blood cells to fight infection; red blood cells that carry oxygen; and platelets that help blood clot and stop bleeding. The term ‘risk’ refers to the chance of the cancer coming back after treatment

Your ALL may be classified as “High Risk” for several reasons:

  • You are 10 years of age or older;
  • You have a white blood cell count of over 50 000/microliter at diagnosis;
  • You are a male and have leukemia in your testes;
  • You have leukemia in the spinal fluid (the fluid surrounding the brain and spinal cord) or the brain; or
  • You received treatment with steroid medications, such as prednisone or dexamethasone, in the month before you were diagnosed.

This study is organized by Children's Oncology Group (COG). The purpose of the study is to closely monitor patients, with the aim of reducing the number of unintended and unwanted results of treatment (serious side effects) and deaths among children and adolescents with DS HR-ALL.

Approximately 4 people will take part in this study conducted by investigators at the University of Iowa. The total number of people enrolled nationally on this study is expected to be 4450.

Start Date
June 1, 2012
End Date
June 1, 2022
Gender Preference
None
Age Group
1 - 30 years
Principal Investigator
Ayman El-Sheikh, MD
Contact Info

Victoria Scaccia, (319) 356-7875

Department
Department or Field of Study
Keywords
acute lymphoblastic leukemia (ALL) ; cancer ; children ; clofarabine (IND 73789) ; cyclophosphamide ; down syndrome (DS HR-ALL) ; etoposide ; high risk (HR-ALL) ; high risk B-precursor ; induction therapy ; MBFM-IMHDM backbone ; pediatric ; phase 3 ; phase III ; VHR-ALL ;

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