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Clinical Trial Summary

This is a pilot study using decitabine and vorinostat before and during chemotherapy with vincristine, dexamethasone, mitoxantrone, and peg-asparaginase in pediatric patients with acute lymphoblastic leukemia (ALL).


Clinical Trial Description

Decitabine is a demethylating agent and vorinostat is a HDAC inhibitor. The use of demethylating agents and HDAC inhibitors in combination have been previously shown to have synergistic effects in altering neoplastic pathways of cancer cells and be well tolerated in human clinical studies. With the ability of decitabine and vorinostat to alter the abnormal cellular pathways of leukemic blasts and essentially turn off anti-apoptotic proteins, the leukemia cells have become primed for cytotoxic cell kill via chemotherapeutic agents. This study will ask the question as to whether or not the combination of decitabine and vorinostat followed by chemotherapy is feasible and whether it can positively impact outcome in patients with relapsed or refractory acute lymphoblastic leukemia. ;


Study Design


Related Conditions & MeSH terms

  • Acute Lymphoblastic Leukemia
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor B-Cell Lymphoblastic Leukemia
  • Precursor B-Cell Lymphoblastic Leukemia-Lymphoma
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Precursor T-Cell Lymphoblastic Leukemia
  • Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

NCT number NCT01483690
Study type Interventional
Source Therapeutic Advances in Childhood Leukemia Consortium
Contact
Status Terminated
Phase Phase 1/Phase 2
Start date December 2011
Completion date July 31, 2015

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