NCT00002800

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of high-dose cytarabine plus idarubicin in treating patients with newly diagnosed acute or chronic myelogenous leukemia or myelodysplastic syndrome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for phase_2 leukemia

Timeline
Completed

Started Jul 1996

Typical duration for phase_2 leukemia

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1996

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2003

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

April 22, 2004

Completed
Last Updated

July 3, 2013

Status Verified

July 1, 2013

Enrollment Period

6.7 years

First QC Date

November 1, 1999

Last Update Submit

July 1, 2013

Conditions

LeukemiaMyelodysplastic SyndromesNeutropenia

Keywords

accelerated phase chronic myelogenous leukemiablastic phase chronic myelogenous leukemiauntreated adult acute myeloid leukemiarefractory anemia with excess blastsrefractory anemia with excess blasts in transformationchronic myelomonocytic leukemiade novo myelodysplastic syndromesneutropenia

Interventions

filgrastimBIOLOGICAL
lintuzumabBIOLOGICAL
cytarabineDRUG
etoposideDRUG
idarubicinDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: One of the following hematologic malignancies that is ineligible for higher priority protocols and confirmed at Memorial Hospital: Acute myelogenous leukemia Accelerated or blastic phase (greater than 10% blasts in marrow) chronic myelogenous leukemia Poor-risk myelodysplastic syndrome, defined as: Refractory anemia with excess blasts (RAEB) with at least 10% marrow blasts and cytopenia requiring therapy RAEB in transformation Chronic myelomonocytic leukemia No acute promyelocytic leukemia PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2.0 mg/dL Transaminases no greater than 3 times normal Renal: Creatinine no greater than 2.0 mg/dL OR Creatinine clearance greater than 60 mL/min Cardiovascular: No cardiomyopathy No symptomatic congestive heart failure Other: No concurrent active malignancy No pregnant or nursing women PRIOR CONCURRENT THERAPY: No prior therapy except biologic agent alone or hydroxyurea

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

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

LeukemiaMyelodysplastic SyndromesNeutropeniaLeukemia, Myeloid, Accelerated PhaseBlast CrisisAnemia, Refractory, with Excess of BlastsLeukemia, Myelomonocytic, Chronic

Interventions

FilgrastimlintuzumabCytarabineEtoposideIdarubicin

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesBone Marrow DiseasesAgranulocytosisLeukopeniaCytopeniaLeukocyte DisordersLeukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemia, MyeloidMyeloproliferative DisordersChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsCell Transformation, NeoplasticCarcinogenesisNeoplastic ProcessesAnemia, RefractoryAnemiaMyelodysplastic-Myeloproliferative 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 NucleosidesPodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsGlucosidesGlycosidesDaunorubicinAnthracyclinesNaphthacenesAminoglycosides

Study Officials

  • Peter Maslak, MD

    Memorial Sloan Kettering Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

April 22, 2004

Study Start

July 1, 1996

Primary Completion

March 1, 2003

Study Completion

March 1, 2003

Last Updated

July 3, 2013

Record last verified: 2013-07

Locations

US(1)