NCT00451997

Brief Summary

The goal of this clinical research study is to learn if the combination of Gleevec (imatinib mesylate) and low doses of Cytarabine (ara-C) may help to control leukemia while causing fewer side effects than standard high dose chemotherapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2004

Typical duration for phase_2

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, 2004

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2005

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

March 23, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 26, 2007

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

August 1, 2012

Status Verified

July 1, 2012

Enrollment Period

1.4 years

First QC Date

March 23, 2007

Last Update Submit

July 31, 2012

Conditions

Leukemia, MyeloidMyelodysplastic Syndromes

Keywords

AMLMDSGleevecAra-CC-Kit Positive Acute Myeloid LeukemiaHigh-Risk Myelodysplastic Syndromes

Outcome Measures

Primary Outcomes (1)

  • Efficacy of a combination of imatinib and low dose ara-C in elderly or high-risk patients with AML and MDS, as measured by the rate of early mortality or progression.

    April 2007

Secondary Outcomes (7)

  • Rate of overall response, including CRp and PR.

    April 2007

  • To determine the safety profile of this combination.

    April 2007

  • To determine the impact on long-term survival of this therapy.

    April 2007

  • To determine the duration of responses obtained with this therapy.

    April 2007

  • To determine the impact of this therapy in cognitive function.

    April 2007

  • +2 more secondary outcomes

Study Arms (1)

Gleevec + Low-Dose Ara-C

EXPERIMENTAL
Drug: GleevecDrug: Ara-C

Interventions

GleevecDRUG

600 mg (capsules) by mouth once daily

Also known as: Imatinib Mesylate, STI-571, Imatinib, NSC-716051
Gleevec + Low-Dose Ara-C
Ara-CDRUG

10 mg as an injection under the skin daily for 21 days of every 28 day cycle

Also known as: Cytarabine, Cytosar-U®, DepoCyt, Cytosine arabinosine hydrochloride, Arabinosylcytosine
Gleevec + Low-Dose Ara-C

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who are not candidates for intensive chemotherapy with any of the following diagnosis: 1. AML or MDS (with \>/=5% blasts) age \>/= 65 years old (or age \>/= 60 if high-risk cytogenetics), or 2. AML or MDS (RAEB or RAEBT) of any cytogenetic group age 60 or older with minimally treated disease who have relapsed disease or are refractory to therapy and not likely to require cytoreductive therapy within one month, and, or 3. CMML.
  • Patients with WHO performance status of 0 to 2
  • Patients must have recovered from prior cytotoxic chemotherapy; treatment with hydrea is allowed up to 24 hours prior to day 1 of study drug administration
  • Written informed consent obtained according to local guidelines
  • Patients must have a serum creatinine of \</= 1.5 x ULN, SGPT \</= 3 x ULN and total bilirubin \</= 2.0 x ULN.
  • Patients with \>/= 20% blasts positive for c-kit (CD117) (except for CMML)
  • Postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Male and female patients of childbearing potential must agree to employ an effective method of birth control throughout the study and for up to 3 months following discontinuation of study drug.

You may not qualify if:

  • Patients with uncontrolled active infection
  • Patients with NYHA class III or IV
  • Women who are pregnant
  • Women who are breast feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Leukemia, MyeloidMyelodysplastic Syndromes

Interventions

Imatinib MesylateCytarabine

Condition Hierarchy (Ancestors)

LeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesBone Marrow Diseases

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic ChemicalsBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidinesCytidinePyrimidine NucleosidesArabinonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Jorge E Cortes, MD

    The University of M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 23, 2007

First Posted

March 26, 2007

Study Start

March 1, 2004

Primary Completion

August 1, 2005

Study Completion

April 1, 2007

Last Updated

August 1, 2012

Record last verified: 2012-07

Locations

US(1)