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Safety and Efficacy of Imatinib in Combination With High Dose Chemotherapy for Acute Phase Chronic Myelogenous Patients | Clinical Trials | Clareo Health

TERMINATEDPHASE1/PHASE2

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

Phase I/II Trial to Study the Dose, Tolerability and the Effectiveness of Imatinib in Combination With Daunorubicine and Cytarabine for Patients With Chronic Myelogenous Leukemia in Myeloid Acute Phase

NCT00219765•Poitiers University Hospital

View on ClinicalTrials.gov

Summary

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

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (1)

University Hospital

Poitiers, France

Key Dates

Start Date

May 1, 2001

Completion Date

January 1, 2006

Last Updated

November 28, 2005

Enrollment

Estimated participants

Conditions

Chronic Myeloid Leukemia

Interventions

Imatinib mesylate 600 mg

DRUG

Cytarabine

DRUG

Daunorubicine

DRUG

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High-risk Myelodysplastic SyndromeChronic Myelomonocytic Leukemia (CMML)+2 more

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RECRUITINGPHASE1/PHASE2

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Atypical Chronic Myeloid LeukemiaChronic Myelomonocytic Leukemia+6 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 28, 2005Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study of CBX-250 in Participants With Relapsed or Refractory Myeloid Leukemias

Axatilimab With or Without Azacitidine for the Treatment of Patients With Advanced Phase Myeloproliferative Neoplasms, Myeloproliferative Neoplasm/Myelodysplastic Syndrome Overlap or High Risk Chronic Myelomonocytic Leukemia

Phase II Study Assessing Efficacy and Safety of Asciminib in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase.

Donor Stem Cell Transplant With Treosulfan, Fludarabine, and Total-Body Irradiation for the Treatment of Hematological Malignancies

Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection

A Study of MGD024 in Patients With Relapsed or Refractory Hematologic Malignancies