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Safety and Efficacy of Imatinib in Combination With High Dose Chemotherapy for Acute Phase Chronic Myelogenous Patients

NCT ID: NCT00219765

Last Updated: 2005-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-05-31

Study Completion Date

2006-01-31

Brief Summary

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The aim of this phase I/II trial is to determine the dose of daunorubicine to be associated with cytarabine and Imatinib for induction therapy in patients with chronic myelogenous leukemia in myeloid acute phase.

Detailed Description

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Study design Imatinib: starting at day -3: 600mg/day; continuous administration In combination with cytarabine: continuous iv/24h: 100mg/m² ; 7 days and daunorubicine: 4 levels

level 1: 0

level 2: 15mg/m² ; 3 days

level 3: 30mg/m² ; 3 days

level 4: 45mg/m² ; 3 days

Conditions

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Chronic Myeloid Leukemia

Keywords

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CML Acute Phase Imatinib mesylate Cytarabine Daunorubicine

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Imatinib mesylate 600 mg

Intervention Type DRUG

Cytarabine

Intervention Type DRUG

Daunorubicine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* CML Ph+ (assessed by cytogenetic or FISH)
* Acute phase with ≥ 20% bone marrow blasts (M0 to M6 , excluding M3)
* Age ≥ 18 year at inclusion
* PS grade 0 to 2 (ECOG)
* Adequate and organ function, defined as the following: total bilirubin \<1.5x uln, sgpt \<3x uln, creatinine \<1.5x uln.
* Informed consent signed up

Exclusion Criteria

* active malignancy other than CML or non-melanoma cancer of the skin
* current treatment with another investigational agent
* patients with grade 3/4 cardiac disease or any other serious concurrent medical condition.
* patients who are pregnant or nursing. All patients of childbearing potential must practice effective methods of contraception while on study.
* patients with mental illness or other condition precluding their ability to give informed consent or to comply with study requirements patients with performans status 3-4
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, France

OTHER_GOV

Sponsor Role collaborator

Novartis

INDUSTRY

Sponsor Role collaborator

Poitiers University Hospital

OTHER

Sponsor Role lead

Principal Investigators

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François GUILHOT, MD

Role: STUDY_CHAIR

Department of Oncology hematology and Cell therapy, University Hospital , 86021 Poitiers - FRANCE

Locations

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University Hospital

Poitiers, , France

Site Status

Countries

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France

References

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Rousselot P, Cony-Makhoul P, Nicolini F, Mahon FX, Berthou C, Rea D, Reiffers J, Bornand A, Saint-Jean O, Guilhot J, Guilhot F; French Intergroup For Chronic Myelogenous Leukemia (Fi-LMC). Long-term safety and efficacy of imatinib mesylate (Gleevec(R)) in elderly patients with chronic phase chronic myelogenous leukemia: results of the AFR04 study. Am J Hematol. 2013 Jan;88(1):1-4. doi: 10.1002/ajh.23330. Epub 2012 Sep 17.

Reference Type DERIVED
PMID: 22987312 (View on PubMed)

Deau B, Nicolini FE, Guilhot J, Huguet F, Guerci A, Legros L, Pautas C, Berthou C, Guyotat D, Cony-Makhoul P, Gardembas M, Michallet M, Hayette S, Cayuela JM, Weiss IR, Rea D, Castaigne S, Mahon FX, Guilhot F, Rousselot P. The addition of daunorubicin to imatinib mesylate in combination with cytarabine improves the response rate and the survival of patients with myeloid blast crisis chronic myelogenous leukemia (AFR01 study). Leuk Res. 2011 Jun;35(6):777-82. doi: 10.1016/j.leukres.2010.11.004. Epub 2010 Dec 10.

Reference Type DERIVED
PMID: 21145590 (View on PubMed)

Other Identifiers

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CSTI571AFR01

Identifier Type: -

Identifier Source: secondary_id

010495

Identifier Type: -

Identifier Source: org_study_id