NCT00053131

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jan 1999

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1999

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

January 27, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 28, 2003

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2004

Completed
Last Updated

March 8, 2011

Status Verified

March 1, 2011

Enrollment Period

5.1 years

First QC Date

January 27, 2003

Last Update Submit

March 7, 2011

Conditions

Leukemia

Keywords

recurrent adult acute myeloid leukemiarecurrent childhood acute myeloid leukemiarecurrent adult acute lymphoblastic leukemiarecurrent childhood acute lymphoblastic leukemia

Interventions

filgrastimBIOLOGICAL
sargramostimBIOLOGICAL
cytarabineDRUG
mitoxantrone hydrochlorideDRUG

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

MeSH Terms

Conditions

LeukemiaLeukemia, Myeloid, AcutePrecursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

FilgrastimsargramostimCytarabineMitoxantrone

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, MyeloidLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsArabinonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesAnthraquinonesAnthronesAnthracenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsQuinonesPolycyclic Compounds

Study Officials

  • Maria R. Baer, MD

    Roswell Park Cancer Institute

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 27, 2003

First Posted

January 28, 2003

Study Start

January 1, 1999

Primary Completion

February 1, 2004

Study Completion

February 1, 2004

Last Updated

March 8, 2011

Record last verified: 2011-03

Locations

US(1)