NCT00528450

Brief Summary

RATIONALE: Tretinoin may help cancer cells become more like normal cells, and to grow and spread more slowly. Drugs used in chemotherapy, such as arsenic trioxide and idarubicin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving tretinoin together with arsenic trioxide with or without idarubicin may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving tretinoin together with arsenic trioxide with or without idarubicin works in treating patients with acute promyelocytic leukemia.

Trial Health

57
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Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for phase_2 leukemia

Timeline
Completed

Started Sep 2007

Geographic Reach
1 country

1 active site

Status
terminated

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

September 1, 2007

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

September 10, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 12, 2007

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
5.1 years until next milestone

Results Posted

Study results publicly available

January 29, 2016

Completed
Last Updated

January 29, 2016

Status Verified

December 1, 2015

Enrollment Period

3.3 years

First QC Date

September 10, 2007

Results QC Date

December 23, 2015

Last Update Submit

December 23, 2015

Conditions

Leukemia

Keywords

adult acute promyelocytic leukemia (M3)adult acute myeloid leukemia with t(15;17)(q22;q12)untreated adult acute myeloid leukemia

Outcome Measures

Primary Outcomes (1)

  • Molecular Remission Rate

    \# of patients with Complete Remission

    2 years

Study Arms (1)

Tretinoin and Arsenic Trioxide With or Without Idarubicin

EXPERIMENTAL

See Outline for details

Drug: arsenic trioxideDrug: idarubicinDrug: tretinoin

Interventions

arsenic trioxideDRUG
Tretinoin and Arsenic Trioxide With or Without Idarubicin
idarubicinDRUG
Tretinoin and Arsenic Trioxide With or Without Idarubicin
tretinoinDRUG
Tretinoin and Arsenic Trioxide With or Without Idarubicin

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Morphologic diagnosis of acute promyelocytic leukemia (APL), confirmed by one of the following: * Demonstration of t(15;17) using conventional cytogenetics or fluorescence in situ hybridization (FISH) * Positive PML-RARα transcript by reverse transcriptase-polymerase chain reaction (RT-PCR) assay * Patients with CNS involvement by APL are eligible PATIENT CHARACTERISTICS: * Karnofsky performance status 60-100% * Creatinine ≤ 2.0 mg/dL or creatinine clearance \> 60 mL/min * Bilirubin \< 2.0 mg/dL (unless attributed to Gilbert disease) * Alkaline phosphatase ≤ 2.5 times the upper limit of normal (ULN) * AST and ALT ≤ 2.5 ULN * LVEF ≥ 50% on echocardiogram or MUGA scan * QTc ≤ 500 msec on baseline ECG * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for ≥ 4 months after the completion of study treatment * No active serious infections not controlled by antibiotics * No other concurrent active malignancy requiring immediate therapy * No clinically significant cardiac disease (New York Heart Association class III or IV heart disease), including chronic arrhythmias * No pulmonary disease * No other serious or life-threatening condition deemed unacceptable by the principal investigator PRIOR CONCURRENT THERAPY: * No prior treatment for APL

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

Arsenic TrioxideIdarubicinTretinoin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

ArsenicalsInorganic ChemicalsOxidesOxygen CompoundsDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesVitamin ARetinoidsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicTerpenesDiterpenesPigments, BiologicalBiological Factors

Results Point of Contact

Title
Dr. Peter Maslak
Organization
Memorial Sloan Kettering Cancer Center
maslakp@mskcc.org
212-639-5518

Study Officials

  • Joseph G. Jurcic, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

  • Peter Maslak, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2007

First Posted

September 12, 2007

Study Start

September 1, 2007

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

January 29, 2016

Results First Posted

January 29, 2016

Record last verified: 2015-12

Locations

US(1)