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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

January 27, 2003

Last Updated Date

February 6, 2009

Start Date ^†

December 1999

Current Primary Outcome Measures ^†

Original Primary Outcome Measures ^†

Change History

Complete list of historical versions of study NCT00053131 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

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

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

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.

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.

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Active Control

Condition ^†

Leukemia

Intervention ^†

Biological: filgrastim
Biological: sargramostim
Drug: cytarabine
Drug: mitoxantrone hydrochloride

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

Completion Date

Primary Completion Date

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

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

Gender

Both

Ages

15 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00053131

Responsible Party

Secondary IDs ^††

RPCI-RPC-9902

Study Sponsor ^†

Roswell Park Cancer Institute

Collaborators ^††

National Cancer Institute (NCI)

Investigators ^†

Study Chair:

Maria R. Baer, MD

Roswell Park Cancer Institute

Information Provided By

National Cancer Institute (NCI)

Verification Date

February 2004

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.