drugset / Trial / NCT00004862

Augmerosen Plus Fludarabine and Cytarabine in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia

NCT00004862

Phase 1 Completed 24 enrolled National Cancer Institute (NCI)
NaSingle-groupOpen-labelTreatment

Summary

Phase I trial to study the effectiveness of augmerosen plus fludarabine and cytarabine in treating patients who have refractory or relapsed acute myeloid leukemia or acute lymphoblastic leukemia. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Gene therapy such as augmerosen may make cancer cells more sensitive to chemotherapy drugs. Combining more than one drug with augmerosen may kill more cancer cells.

Timeline

Start
1999-10
Primary completion
2001-12
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Cytarabine Small molecule Intravenous
Subject Fludarabine Small molecule Intravenous
Subject oblimersen sodium Antisense oligonucleotide Intravenous
Background filgrastim Protein / enzyme biologic Subcutaneous

Indications