NCT00016159

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining monoclonal antibody therapy with chemotherapy may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and monoclonal antibody in treating patients who have acute promyelocytic leukemia.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2000

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2001

Completed
1.7 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Last Updated

January 16, 2013

Status Verified

January 1, 2013

Enrollment Period

6.3 years

First QC Date

May 6, 2001

Last Update Submit

January 15, 2013

Conditions

Leukemia

Keywords

adult acute myeloid leukemia in remissionchildhood acute myeloid leukemia in remissionadult acute promyelocytic leukemia (M3)childhood acute promyelocytic leukemia (M3)adult acute myeloid leukemia with t(15;17)(q22;q12)

Outcome Measures

Primary Outcomes (1)

  • reverse transcriptase-polymerase chain reaction negativity

Interventions

filgrastimBIOLOGICAL
lintuzumabBIOLOGICAL
arsenic trioxideDRUG
idarubicinDRUG
tretinoinDRUG

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of acute promyelocytic leukemia by positive RT-PCR assay for PML/RAR-alfa rearrangement or a t(15;17) karyotype * Achieved clinical complete remission within the past 1-2 months * Prior induction therapy must have contained tretinoin * No other acute myeloid leukemia diagnosis PATIENT CHARACTERISTICS: Age: * Any age Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Bilirubin less than 2 mg/dL * Transaminases no greater than 3 times upper limit of normal Renal: * Creatinine less than 2 mg/dL OR * Creatinine clearance greater than 60 mL/min Cardiovascular: * Ejection fraction normal or greater than 50% by echocardiogram or MUGA Other: * No other concurrent active malignancy * No other serious or life-threatening condition that would preclude study * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for at least 4 months after study PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * See Disease Characteristics * At least 1 week since prior retinoids Endocrine therapy: * Not specified Radiotherapy: * Not specified Surgery: * Not specified Other: * No prior postremission therapy of any form

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

LeukemiaLeukemia, Promyelocytic, Acute

Interventions

FilgrastimlintuzumabArsenic TrioxideIdarubicinTretinoin

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, Myeloid, AcuteLeukemia, Myeloid

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsArsenicalsInorganic ChemicalsOxidesOxygen CompoundsDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesVitamin ARetinoidsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicTerpenesDiterpenesPigments, Biological

Study Officials

  • Joseph G. Jurcic, 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

May 6, 2001

First Posted

January 27, 2003

Study Start

November 1, 2000

Primary Completion

March 1, 2007

Last Updated

January 16, 2013

Record last verified: 2013-01

Locations

US(1)