Effect of Tight Control of Blood Glucose During Hyper-CVAD Chemotherapy For Acute Lymphocytic Leukemia (ALL)

Phase 3 Terminated 52 enrolled M.D. Anderson Cancer Center Novo Nordisk A/S · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

The goal of this clinical research study is to learn if intense management and control of blood sugar levels during treatment for acute lymphocytic leukemia, Burkitts lymphoma, or lymphoblastic lymphoma will result in decreased risk of relapse, fewer complications, and/or longer survival.

Timeline

Start: 2004-04
Primary completion: 2012-04
Completion: 2012-04

Outcome

Missed primary endpoint

Stopped: “Terminated early due to futility.”

paper Intensive insulin did not improve ALL clinical outcomes despite improved glycemic control. PMID 22658895 ↗

Publications

Vu K, Busaidy N, Cabanillas ME, Konopleva M, Faderl S, Thomas DA, O'Brien S, Broglio K, Ensor J, Escalante C, Andreeff M, Kantarjian H, Lavis V, Yeung SC. A randomized controlled trial of an intensive insulin regimen in patients with hyperglycemic acute lymphoblastic leukemia. Clin Lymphoma Myeloma Leuk. 2012 Oct;12(5):355-62. doi: 10.1016/j.clml.2012.05.004. Epub 2012 Jun 1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	insulin aspart	Protein / enzyme biologic	—	—
Subject	insulin glargine	Protein / enzyme biologic	—	—