Research and Clinical Trials

Title  
AAML0631 Risk Adapted Treatment of Newly Diagnosed Childhood Acute Promyelocytic Leukemia (APL) using Arsenic Trioxide (Trisenox® IND# 103,331) During Consolidation
Brief Description  
This phase III trial is studying combination chemotherapy to see how well it works in treating young patients with newly diagnosed acute promyelocytic leukemia
Who may be Eligible  

  • New clinically and morphologically confirmed diagnosis of acute promyelocytic leukemia (APL)
  • If the real-time quantitative (RQ)-PCR results are known, the patient must demonstrate PML-RARA and/or RARA-PML transcripts by RQ-PCR
  • Patients without evidence of APL by bone marrow morphology but with isolated myeloid sarcoma (myeloblastoma; chloroma, including leukemia cutis) are eligible provided that the t(15;17) translocation is documented on either marrow or tumor tissue by cytogenetics, FISH, or PCR prior to study enrollment (in this situation, touch preps from the tumor site can be evaluated by FISH with PML-RARA probes)
  • 2 to 21 years
  • Not pregnant or nursing
  • Prior intrathecal cytarabine prior to the diagnosis of acute promyelocytic leukemia (APL) allowed
  • Prior corticosteroids, hydroxyurea, and leukapheresis allowed
  • No prior systemic definitive treatment for APL, including cytotoxic chemotherapy, retinoids, or arsenic
IRB Number  
05-09-03A
Principal Investigator  
Kaplan, Joel

For More Information, Contact  Wendy  , Bissette
Phone:  (704) 355-9081  Fax:  (704) 355-1188  
Email:  Wendy.Bissette@carolinashealthcare.org
Address:1025 Morehead Medical Drive
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