NCT00276601

Brief Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving combination chemotherapy works in treating patients with acute promyelocytic leukemia.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Oct 2004

Typical duration for phase_2 leukemia

Geographic Reach
1 country

7 active sites

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

October 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

January 12, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 13, 2006

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
5.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

April 17, 2014

Status Verified

April 1, 2014

Enrollment Period

3.2 years

First QC Date

January 12, 2006

Last Update Submit

April 16, 2014

Conditions

Leukemia

Keywords

untreated adult acute myeloid leukemiauntreated childhood acute myeloid leukemia and other myeloid malignanciesadult acute promyelocytic leukemia (M3)childhood acute promyelocytic leukemia (M3)adult acute myeloid leukemia with t(15;17)(q22;q12)

Outcome Measures

Primary Outcomes (2)

  • Disease-free survival at 2 and 5 years after study completion

  • Safety of arsenic trioxide following cytarabine and anthracycline immediately after study completion

Secondary Outcomes (1)

  • Validate peripheral blood real-time PCR for minimal disease monitoring as measured by real-time PCR for PML-RARalpha monthly for two years after study completion

Interventions

arsenic trioxideDRUG
cytarabineDRUG
daunorubicin hydrochlorideDRUG
mercaptopurineDRUG
methotrexateDRUG
tretinoinDRUG

Eligibility Criteria

Age5 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of acute promyelocytic leukemia (APL) by morphologic and flow cytometric documentation (high orthogonal light scatter, lack of HLA-DR expression) * Patients with classical APL as well as the microgranular variant (M3V) are eligible * In cases where the diagnosis is unclear, consultation with a hematopathologist is required before enrolling the patient in the study * Patients found to have cytogenetic abnormalities that do not produce the PML-RARα gene rearrangement will be removed from study and will not be included in data analysis PATIENT CHARACTERISTICS: * Patients will not be excluded because of performance status or comorbid disease * Premenopausal female patients must have a negative pregnancy test PRIOR CONCURRENT THERAPY: * No prior chemotherapy for APL except hydroxyurea

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

Sponsors & Collaborators

Study Sites (7)

Comprehensive Cancer Center at University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

University of Florida Shands Cancer Center

Gainesville, Florida, 32610-0232, United States

Location

Blood and Marrow Transplant Group of Georgia

Atlanta, Georgia, 30342, United States

Location

Greenebaum Cancer Center at University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

UNMC Eppley Cancer Center at the University of Nebraska Medical Center

Omaha, Nebraska, 68198-3330, United States

Location

Hillman Cancer Center at University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

LeukemiaLeukemia, Promyelocytic, Acute

Interventions

Arsenic TrioxideCytarabineDaunorubicinMercaptopurineMethotrexateTretinoin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

ArsenicalsInorganic ChemicalsOxidesOxygen CompoundsCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsArabinonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesSulfhydryl CompoundsSulfur CompoundsPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingAminopterinPterinsPteridinesVitamin ARetinoidsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicTerpenesDiterpenesPigments, BiologicalBiological Factors

Study Officials

  • Steven D. Gore, MD

    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 12, 2006

First Posted

January 13, 2006

Study Start

October 1, 2004

Primary Completion

December 1, 2007

Study Completion

June 1, 2013

Last Updated

April 17, 2014

Record last verified: 2014-04

Locations

US(7)