NCT00015860

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. STI571 may stop the growth of leukemia cells. Combining chemotherapy and STI571 may kill more cancer cells. PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy plus STI571 in treating patients who have chronic myelogenous leukemia or acute lymphocytic leukemia.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started May 2001

Shorter than P25 for phase_1 leukemia

Geographic Reach
1 country

5 active sites

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

May 1, 2001

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

May 6, 2001

Completed
1.7 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2003

Completed
Last Updated

June 24, 2013

Status Verified

September 1, 2003

First QC Date

May 6, 2001

Last Update Submit

June 20, 2013

Conditions

Leukemia

Keywords

recurrent adult acute lymphoblastic leukemiarelapsing chronic myelogenous leukemiablastic phase chronic myelogenous leukemia

Interventions

daunorubicin hydrochlorideDRUG
imatinib mesylateDRUG
prednisoneDRUG
vincristine sulfateDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * One of the following diagnoses: * Chronic myelogenous leukemia in lymphoid blast crisis * Acute lymphoblastic leukemia (ALL) that is in first relapse or failed induction * No more than 1 prior course of induction chemotherapy * Philadelphia chromosome-positive (Ph+) by cytogenetic analysis OR bcr/abl translocation by fluorescent in situ hybridization * At least 30% blasts in bone marrow * Ineligible for or refused allogeneic stem cell transplantation * Not previously treated with imatinib mesylate OR currently receiving imatinib mesylate with stable disease on 2 bone marrow biopsies at least 2 weeks apart PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * Not specified Hematopoietic: * See Disease Characteristics Hepatic: * Bilirubin less than 3 times upper limit of normal (ULN) * ALT and AST less than 3 times ULN Renal: * Creatinine less than 2 times ULN Cardiovascular: * No New York Heart Association class III or IV cardiac disease Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective barrier contraception during and for at least 2 weeks after study for female patients and at least 3 months after study for male patients PRIOR CONCURRENT THERAPY: Biologic therapy: * See Disease Characteristics * No prior allogeneic bone marrow or peripheral blood stem cell transplantation * At least 48 hours since prior interferon alfa Chemotherapy: * See Disease Characteristics * At least 24 hours since prior hydroxyurea * At least 6 weeks since prior busulfan * Concurrent hydroxyurea or anagrelide for severe leukocytosis or thrombocytosis allowed Endocrine therapy: * Not specified Radiotherapy: * Not specified Surgery: * Not specified Other: * No prior therapy for blast crisis except hydroxyurea * No prior salvage or reinduction therapy for Ph+ ALL * At least 4 weeks since other prior investigational agents

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

Sponsors & Collaborators

Study Sites (5)

City of Hope Comprehensive Cancer Center

Duarte, California, 91010, United States

Location

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095, United States

Location

Stanford University Medical Center

Stanford, California, 94305-5408, United States

Location

Oregon Cancer Institute

Portland, Oregon, 97239, United States

Location

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

MeSH Terms

Conditions

LeukemiaPrecursor Cell Lymphoblastic Leukemia-LymphomaBlast Crisis

Interventions

DaunorubicinImatinib MesylatePrednisoneVincristine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemia, MyeloidCell Transformation, NeoplasticCarcinogenesisNeoplastic ProcessesMyeloproliferative DisordersBone Marrow DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesBenzamidesAmidesBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidinesPregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizines

Study Officials

  • Ronald Paquette, MD

    Jonsson Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 6, 2001

First Posted

January 27, 2003

Study Start

May 1, 2001

Study Completion

October 1, 2003

Last Updated

June 24, 2013

Record last verified: 2003-09

Locations

US(5)