drugset / Trial / NCT00053131

Combination Chemotherapy Followed By Filgrastim or Sargramostim in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia

NCT00053131

Phase 2 Completed Roswell Park Cancer Institute
RandomizedTreatment

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Colony-stimulating factors such as filgrastim and sargramostim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. It is not yet known whether combination chemotherapy is more effective followed by filgrastim or sargramostim in treating leukemia. PURPOSE: Randomized phase II trial to compare the effectiveness of combination chemotherapy followed by filgrastim with that of combination chemotherapy followed by sargramostim in treating patients who have relapsed or refractory acute myeloid leukemia or acute lymphoblastic leukemia.

Timeline

Start
1999-01
Primary completion
2004-02
Completion
2004-02

Drugs

EvaluationDrugModalityDoseRoute
Subject filgrastim Protein / enzyme biologic Subcutaneous
Subject sargramostim Protein / enzyme biologic Subcutaneous
Background Cytarabine Small molecule Intravenous
Background Mitoxantrone Small molecule Intravenous

Indications