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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00053131
Recruitment Status : Completed
First Posted : January 28, 2003
Last Update Posted : March 8, 2011
Information provided by:
Roswell Park Cancer Institute

Brief 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.

Condition or disease Intervention/treatment Phase
Leukemia Biological: filgrastim Biological: sargramostim Drug: cytarabine Drug: mitoxantrone hydrochloride Phase 2

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Primary Purpose: Treatment
Official Title: High Dose Cytarabine And Mitoxantrone Therapy For Relapsed And Refractory Acute Myeloid And Lymphocytic Leukemia: Effects Of GM-CSF Versus G-CSF On Dendritic Cells And Leukemia Associated Antigen-Specific T-Lymphocytes
Study Start Date : January 1999
Actual Primary Completion Date : February 2004
Actual Study Completion Date : February 2004

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 15 and over

Performance status

  • 0-3

Life expectancy

  • At least 4 weeks


  • Not specified


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


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


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


  • 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


Biologic therapy

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


  • Prior chemotherapy allowed

Endocrine therapy

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


  • Prior radiotherapy allowed


  • Not specified

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00053131

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United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Sponsors and Collaborators
Roswell Park Cancer Institute
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Study Chair: Maria R. Baer, MD Roswell Park Cancer Institute

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Responsible Party: Maria Bear, MD, Roswell Park Cancer Institute Identifier: NCT00053131     History of Changes
Other Study ID Numbers: CDR0000269285
First Posted: January 28, 2003    Key Record Dates
Last Update Posted: March 8, 2011
Last Verified: March 2011
Keywords provided by Roswell Park Cancer Institute:
recurrent adult acute myeloid leukemia
recurrent childhood acute myeloid leukemia
recurrent adult acute lymphoblastic leukemia
recurrent childhood acute lymphoblastic leukemia
Additional relevant MeSH terms:
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Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Leukemia, Lymphoid
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic
Sensory System Agents
Peripheral Nervous System Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors