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10530 : A phase I window, dose escalating and safety trial of metformin in combination with induction chemotherapy in relapsed refractory acute lymphoblastic leukemia: Metformin with induction chemotherapy of vincristine, dexamethasone, doxorubicin, and PEG-asparaginase (VPLD).

Researchers

Presenter

  • Julio C. Barredo

Principal Investigators

  • John M. Goldberg

  • Gregory Hale

  • Jonathan Benjamin Gill

  • Bhuvana Setty

  • Tiffany Smith

  • Jae K Lee

  • Damon R. Reed

Medical Centers

  • University of Miami Miller School of Medicine, Miami, FL

  • University of Miami Miller School of Medicine, Miami, FL

  • All Children's Hospital, Johns Hopkins Medicine, St. Petersburg, FL

  • Children's Hosp At Montefiore, Randolph, NJ

  • Ohio State University/Nationwide Children's Hospital, Columbus, OH

  • H. Lee Moffitt Cancer Center & Research Institute, Riverview, FL

  • H. Lee Moffitt Cancer Center & Research Institute, Riverview, FL

  • Moffitt Cancer Center, Tampa, FL

Locations

  • United States

Companies

  • N/A

Study Components

Therapeutic Area

  • Oncology (ONC)

Disease

  • Acute lymphoblastic leukemia

Biomarkers

  • AMP-activated protein kinase

Drug/Treatment

  • PEG-asparaginase

  • Dexamethasone

  • Dekpak 13 Day Taperpak

  • Asparaginase

  • Vincristine

  • Doxorubicin

  • Metformin Hydrochloride

Outcome

  • N/A


Study Design

  • Pharmacokinetics

  • Pharmacodynamics

Phase

  • I

Study Id's

  • NCT01324180

Sponsors

  • N/A

Result

  • Final