NCT00002609

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P50-P75 for phase_2 leukemia

Timeline
Completed

Started Aug 1994

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1994

Completed
5.3 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

February 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2003

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

August 11, 2004

Completed
Last Updated

June 24, 2013

Status Verified

June 1, 2013

Enrollment Period

8.5 years

First QC Date

November 1, 1999

Last Update Submit

June 20, 2013

Conditions

Leukemia

Keywords

adult acute myeloid leukemia in remissionchildhood acute myeloid leukemia in remissionadult acute promyelocytic leukemia (M3)childhood acute promyelocytic leukemia (M3)

Interventions

lintuzumabBIOLOGICAL
cytarabineDRUG
idarubicinDRUG

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Pathologically confirmed acute promyelocytic leukemia in one of the following categories: First complete remission following induction retinoids First complete remission following induction chemotherapy and not eligible for additional consolidation chemotherapy Second or subsequent remission following induction retinoids or chemotherapy Clinically complete remission following consolidation chemotherapy and: Detectable minimal residual disease by reverse transcription-polymerase chain reaction (RT-PCR) assay Not eligible for bone marrow transplant Molecular remission (i.e., negative RT-PCR assay) with subsequent evidence of early molecular relapse (i.e., normal peripheral blood counts, normal bone marrow morphology, and positive RT-PCR assay) PATIENT CHARACTERISTICS: Age: 12 and over Performance status: Not specified Life expectancy: Greater than 4 weeks Hematopoietic: See Disease Characteristics Hepatic: Bilirubin no greater than 2.5 mg/dL AST no greater than 4 times normal Alkaline phosphatase no greater than 4 times normal Renal: Creatinine no greater than 2.5 mg/dL Cardiovascular: (Patients receiving idarubicin and cytarabine only) No history of cardiac disease OR Left ventricular ejection fraction greater than 50% by MUGA or echocardiogram Other: No uncontrolled serious infection HIV negative No active second malignancy except basal cell carcinoma Not pregnant or nursing Negative pregnancy test Fertile women must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic therapy Chemotherapy: See Disease Characteristics Retinoid therapy to continue until 30 days past complete remission No other concurrent chemotherapy At least 3 weeks since any cytotoxic chemotherapy and recovered Endocrine therapy: Not specified Radiotherapy: At least 3 weeks since any radiotherapy and recovered No concurrent radiotherapy 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)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

LeukemiaLeukemia, Promyelocytic, Acute

Interventions

lintuzumabCytarabineIdarubicin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

CytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsArabinonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydrates

Study Officials

  • David A. Scheinberg, MD, PhD

    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

August 11, 2004

Study Start

August 1, 1994

Primary Completion

February 1, 2003

Study Completion

February 1, 2003

Last Updated

June 24, 2013

Record last verified: 2013-06

Locations

US(1)