NCT00386373

Brief Summary

Primary Objective: 1\. To assess the safety and toxicity of imatinib mesylate when given to patients with Ph (+) CML , ALL or AML within the first 100 days following allogeneic bone marrow or stem cell transplantation. Secondary Objectives:

  1. 1.To identify any clinically significant drug interactions with imatinib in the post-transplant setting.
  2. 2.To develop specific monitoring parameters for imatinib use when utilized in the early post-BMT setting.
  3. 3.To record one-year survival data in this patient cohort to assess any effect of early imatinib administration on this endpoint.

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 not_applicable leukemia

Timeline
Completed

Started Aug 2003

Typical duration for not_applicable 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2003

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

October 9, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 11, 2006

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

August 1, 2012

Status Verified

July 1, 2012

Enrollment Period

4.2 years

First QC Date

October 9, 2006

Last Update Submit

July 31, 2012

Conditions

Leukemia

Keywords

Chronic Myeloid LeukemiaCMLALLAMLLeukemiaImatinib MesylateGleevecPhiladelphia-PositiveBone marrow transplantBMTStem cell transplantSCT

Outcome Measures

Primary Outcomes (1)

  • Toxicity Rate

    100 Days and 1 Year

Study Arms (1)

Imatinib Mesylate

EXPERIMENTAL
Drug: Imatinib Mesylate

Interventions

Imatinib MesylateDRUG

Starting dose of 100 mg daily by mouth for first 100 days following bone marrow transplant (BMT) or stem cell transplant (SCT).

Also known as: Gleevec, Imatinib, STI571, NSC-716051
Imatinib Mesylate

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with Ph(+) CML and/or CML with bcr-abl rearrangement and diploid cytogenetics not eligible for protocols of higher priority (e.g. ID02-901, DM99-081, DM97-206, etc).
  • The disease must be beyond first chronic phase according to IBMTR criteria (i.e. accelerated phase, blastic phase, second chronic phase) at the time of transplant.
  • Patients with Ph(+) acute lymphocytic (or myeloid) leukemia.
  • Patients with diploid cytogenetics but molecular evidence of bcr-abl rearrangement are also eligible.
  • Age \>/= 16 years
  • Unsupported ANC at least 1500 and unsupported platelet count of at least 50K following BMT.
  • Patients may have received prior chemotherapy for their disease or be previously untreated.
  • Patients must have received an allogeneic bone marrow or stem cell transplant. Allogeneic transplant types may include matched sibling donors, mismatched related donors, or unrelated donors. All preparative regimens acceptable.
  • Signed informed consent
  • Zubrod status \</= 3
  • Adequate hepatic (bilirubin \</= 3 mg/dl, transaminases \< 4 x upper limit of normal) and renal function (serum creatinine \</= 3 mg/dl )

You may not qualify if:

  • Grade III/IV cardiac problems as defined by the NYHAC
  • History of hypersensitivity to imatinib
  • Pregnant and lactating women
  • HIV positive

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

U.T.M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

LeukemiaLeukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

Imatinib Mesylate

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)

BenzamidesAmidesOrganic ChemicalsBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidines

Study Officials

  • Paolo Anderlini, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2006

First Posted

October 11, 2006

Study Start

August 1, 2003

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

August 1, 2012

Record last verified: 2012-07

Locations

US(1)