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CompletedNCT00053131Updated Mar 8, 2011

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

A Phase 2 interventional study of filgrastim and sargramostim in Leukemia, sponsored by Roswell Park Cancer Institute. Completed at 1 site in United States. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2011-03-08.

Sponsored by Roswell Park Cancer Institute · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Allocation
Randomized
Ages
15 Years and older
Sex
All
01

Study 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.

Read the detailed description

OBJECTIVES:

  • Compare amounts of dendritic cells and leukemia-associated antigen-specific T lymphocytes in patients with relapsed or refractory acute myeloid leukemia or acute lymphoblastic leukemia treated with filgrastim (G-CSF) vs sargramostim (GM-CSF) after high-dose cytarabine and mitoxantrone.

OUTLINE: This is a randomized study.

All patients receive high-dose cytarabine IV over 1 hour twice daily on days 1-6 and mitoxantrone IV over 30 minutes on days 2-4. On day 6, patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive filgrastim (G-CSF) subcutaneously (SC) daily until blood counts recover in the absence of unacceptable toxicity.
  • Arm II: Patients receive sargramostim (GM-CSF) SC daily as in arm I.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 6 years.

02

Conditions studied

  • Leukemia

Keywords

  • recurrent adult acute myeloid leukemia
  • recurrent childhood acute myeloid leukemia
  • recurrent adult acute lymphoblastic leukemia
  • recurrent childhood acute lymphoblastic leukemia
03

In context

Leukemia

5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.

Browse Leukemia studies →

Lead sponsor

Roswell Park Cancer Institute is the lead sponsor of 412 studies on the registry; 62 are open to participants now.

Of its 38 completed or terminated interventional studies of FDA-regulated products, 21 (55%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of acute myeloid leukemia or acute lymphoblastic leukemia by morphology, cytochemical staining, and flow cytometry
  • In first or subsequent relapse or refractory disease after at least 1 prior treatment regimen
  • Antecedent hematologic disorders allowed except Philadelphia chromosome-positive chronic myelogenous leukemia

PATIENT CHARACTERISTICS:

Age

  • 15 and over

Performance status

  • 0-3

Life expectancy

  • At least 4 weeks

Hematopoietic

  • Not specified

Hepatic

  • Bilirubin no greater than 2 times normal*
  • SGOT no greater than 2 times normal* NOTE: *Unless directly attributable to leukemia

Renal

  • Creatinine no greater than 1.5 times normal* NOTE: *Unless directly attributable to leukemia

Cardiovascular

  • Ejection fraction at least 45%* NOTE: *Unless directly attributable to leukemia

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other concurrent medical or psychiatric illness that would preclude study entry

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Prior autologous or allogeneic bone marrow or peripheral blood stem cell transplantation allowed
  • Prior cytokines allowed

Chemotherapy

  • Prior chemotherapy allowed

Endocrine therapy

  • No concurrent corticosteroids except for treatment of severe vomiting that is refractory to standard agents

Radiotherapy

  • Prior radiotherapy allowed

Surgery

  • Not specified
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized

Interventions

  • Biologicalfilgrastim
  • Biologicalsargramostim
  • Drugcytarabine
  • Drugmitoxantrone hydrochloride
06

Study locations

1 site
  • Roswell Park Cancer Institute
    Buffalo, New York 14263-0001, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 8, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00053131
Lead sponsor
Roswell Park Cancer Institute
First posted
Jan 28, 2003
Start date
Jan 1999
Primary completion
Feb 2004
Completion
Feb 2004
Last update
Mar 8, 2011

Study contacts

Maria R. Baer, MD
study chair · Roswell Park Cancer Institute

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2011. You cannot join it, but the record below documents what was studied.

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