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Epigenetic Reprogramming in Relapse AML: A Phase 1 Study of Decitabine and Vorinostat Followed by Fludarabine, Cytarabine and G-CSF (FLAG) in Children and Young Adults With Relapsed / Refractory AML

Status
Active
Cancer Type
Acute Myelogenous Leukemia
Leukemia
Trial Phase
Phase I
Eligibility
1 - 25 Years, Male and Female
Study Type
Treatment
NCT ID
NCT03263936
Protocol IDs
T2016-003 (primary)
NCI-2017-02224
Study Sponsor
Therapeutic Advances in Childhood Leukemia Consortium

Summary

This is a pilot study using decitabine and vorinostat before and during chemotherapy with fludarabine, cytarabine and G-CSF (FLAG).

Objectives

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 myelogenous leukemia.

Treatment Sites in Georgia

Aflac Cancer and Blood Disorders Center of Children’s at Egleston


1405 Clifton Road NE
3rd Floor
Atlanta, GA 30322
404-785-0853
www.choa.org

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