Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	15 and over	NCI	RPCI-RPC-9902 NCT00053131

Objectives

1. 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.

Entry 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

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

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

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

Roswell Park Cancer Institute

Maria Baer, MD, Protocol chair(Contact information may not be current)		Ph: 716-845-5975; 800-685-6825

Registry Information
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
Trial Start Date		1999-12-01
Registered in ClinicalTrials.gov		NCT00053131
Date Submitted to PDQ		2002-11-26
Information Last Verified		2004-02-23
NCI Grant/Contract Number		P30-CA16056

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