NCT00003239

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining biological therapy with chemotherapy may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of chemotherapy with cytarabine and homoharringtonine and biological therapy with interferon alfa in treating patients with chronic phase chronic myelogenous leukemia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P75+ for phase_2 leukemia

Timeline
Completed

Started Mar 1998

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

March 1, 1998

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2001

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2001

Completed
2.6 years until next milestone

First Posted

Study publicly available on registry

April 30, 2004

Completed
Last Updated

July 30, 2012

Status Verified

July 1, 2012

Enrollment Period

3.6 years

First QC Date

November 1, 1999

Last Update Submit

July 27, 2012

Conditions

Leukemia

Keywords

chronic phase chronic myelogenous leukemiaPhiladelphia chromosome positive chronic myelogenous leukemiaHomoharringtonineHHTcephalotaxus alkaloidcytarabineInterferon Alpha 2-ARoferon-AAra-CDepotCytCytosine Arabinosine Hydrochloride

Outcome Measures

Primary Outcomes (1)

  • Number of Patients with Complete Cytogenic Response

    Every 3 months

Study Arms (1)

Chemotherapy with Cytarabine + Homoharringtonine

EXPERIMENTAL

Interferon alfa and cytarabine daily by subcutaneous injection. Homoharringtonine is administered by continuous infusion on days 1-5.

Biological: Recombinant Interferon AlfaDrug: CytarabineDrug: Omacetaxine Mepesuccinate

Interventions

Recombinant Interferon AlfaBIOLOGICAL

Daily by subcutaneous injection.

Also known as: Interferon Alpha 2-A, Roferon-A
Chemotherapy with Cytarabine + Homoharringtonine
CytarabineDRUG

Daily by subcutaneous injection.

Also known as: Ara-C, DepotCyt, Cytosine Arabinosine Hydrochloride
Chemotherapy with Cytarabine + Homoharringtonine
Omacetaxine MepesuccinateDRUG

Homoharringtonine is administered by continuous infusion on days 1-5.

Also known as: CGX-635-CML-202, HHT, Homoharringtonine
Chemotherapy with Cytarabine + Homoharringtonine

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Cytologically confirmed early chronic phase chronic myelogenous leukemia (CML) Diagnosed within 12 months Philadelphia chromosome positive OR bcr positive No late chronic phase, accelerated phase, or blastic phase CML PATIENT CHARACTERISTICS: Age: 12 and over Performance status: Zubrod 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin less than 2 mg/dL Renal: Creatinine less than 2 mg/dL Cardiovascular: No severe heart disease Other: No psychoses Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Less than 1 month of prior interferon alfa Chemotherapy: Less than 1 month of prior cytarabine Prior hydroxyurea allowed Endocrine therapy: Not specified Radiotherapy: Not specified 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)

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

Related Links

MeSH Terms

Conditions

LeukemiaLeukemia, Myeloid, Chronic-PhaseLeukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

Interferon-alphaInterferon alpha-2CytarabineHomoharringtonine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, MyeloidMyeloproliferative DisordersBone Marrow DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Interferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsArabinonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesHarringtoninesAlkaloidsBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds, 4 or More Rings

Study Officials

  • Hagop M. Kantarjian, MD

    M.D. Anderson Cancer Center

    STUDY CHAIR

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

November 1, 1999

First Posted

April 30, 2004

Study Start

March 1, 1998

Primary Completion

October 1, 2001

Study Completion

October 1, 2001

Last Updated

July 30, 2012

Record last verified: 2012-07

Locations

US(1)