NCT00244829

Brief Summary

RATIONALE: Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving imatinib mesylate after a donor stem cell transplant may prevent the recurrence of Philadelphia chromosome-positive leukemia. PURPOSE: This phase I/II trial is studying the side effects of giving imatinib mesylate after a donor stem cell transplant and to see how well it works in treating patients with Philadelphia chromosome-positive leukemia.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Jan 2004

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 25, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 27, 2005

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

November 30, 2011

Status Verified

November 1, 2011

First QC Date

October 25, 2005

Last Update Submit

November 28, 2011

Conditions

Leukemia

Keywords

accelerated phase chronic myelogenous leukemiablastic phase chronic myelogenous leukemiachildhood chronic myelogenous leukemiachronic phase chronic myelogenous leukemiaPhiladelphia chromosome positive chronic myelogenous leukemiaadult acute lymphoblastic leukemia in remissionchildhood acute lymphoblastic leukemia in remission

Outcome Measures

Primary Outcomes (1)

  • Safety at 90 days following transplant

Secondary Outcomes (3)

  • BCR/ABL transcript load at 90 days following transplant

  • Standard management of progressive minimal residual disease at 90 days following transplant

  • Survival at 1 year

Interventions

imatinib mesylateDRUG
adjuvant therapyPROCEDURE

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of 1 of the following: * Acute lymphoblastic leukemia or chronic myeloid leukemia (CML) characterized by p\^190 and/or p\^210 bcr/abl gene rearrangement * Accelerated or blastic phase CML * CML in second or greater chronic phase * No imatinib mesylate-resistant leukemia * Planned allogeneic hematopoietic stem cell transplantation * Availability of an appropriately matched related or unrelated donor * Autologous or nonmyeloablative transplantation is not allowed * None of the following within 4 days after the date of neutrophil engraftment\*: * More than 5% marrow blasts * Circulating peripheral blood leukemic blasts * Aberrant antigen expression on marrow myeloblasts ≥ 1% by multidimensional flow cytometric assay * Presence of bcr/abl in \> 5% of marrow interphase nuclei by fluorescent in situ hybridization * More than 1 of 20 Philadelphia chromosome-positive marrow metaphases * CNS involvement by leukemia NOTE: \*The date of neutrophil engraftment is defined as the second consecutive day at which the peripheral blood absolute neutrophil count exceeds 500/mm3 PATIENT CHARACTERISTICS: Performance status * Not specified Life expectancy * At least 2 months Hematopoietic * See Disease Characteristics * Absolute neutrophil count ≥ 1,200/mm\^3 (use of filgrastim \[G-CSF\] allowed) Hepatic * Not specified Renal * Not specified Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No known imatinib mesylate hypersensitivity * No other disease that severely limits life expectancy PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics

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

Sponsors & Collaborators

Study Sites (2)

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-3000, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109-1024, United States

Location

MeSH Terms

Conditions

LeukemiaLeukemia, Myeloid, Accelerated PhaseBlast CrisisLeukemia, Myeloid, Chronic-PhaseLeukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

Imatinib MesylateChemotherapy, Adjuvant

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, MyeloidMyeloproliferative DisordersBone Marrow DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsCell Transformation, NeoplasticCarcinogenesisNeoplastic Processes

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic ChemicalsBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidinesCombined Modality TherapyTherapeuticsDrug Therapy

Study Officials

  • Paul Carpenter, MD

    Fred Hutchinson Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 25, 2005

First Posted

October 27, 2005

Study Start

January 1, 2004

Study Completion

August 1, 2007

Last Updated

November 30, 2011

Record last verified: 2011-11

Locations

US(2)