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Spots Global Cancer Trial Database for Combination Chemotherapy in Treating Patients With Relapsed Acute Myelogenous Leukemia

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Trial Identification

Brief Title: Combination Chemotherapy in Treating Patients With Relapsed Acute Myelogenous Leukemia

Official Title: Treatment of Relapsed Acute Myelogenous Leukemia Consisting of Intermediate Dose Cytosine Arabinoside (ARA-C) Plus Interspaced Continuous Infusion Idarubicin, Followed by Continuous Infusion of Low-Dose ARA-C, A Phase II Study by the EORTC-LCG

Study ID: NCT00003758

Conditions

Leukemia

Study Description

Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy consisting of cytarabine plus idarubicin in treating patients who have relapsed acute myelogenous leukemia.

Detailed Description: OBJECTIVES: I. Assess the feasibility and efficacy of intermediate dose cytarabine plus idarubicin followed by low dose cytarabine in patients with relapsed acute myelogenous leukemia. OUTLINE: This is a multicenter study. Patients receive intermediate dose cytarabine IV over 2 hours twice a day on days 1-5, idarubicin IV over 24 hours on days 1, 3, and 5, and low dose cytarabine IV over 24 hours on days 6-15. If patients achieve complete remission by day 35, this regimen is repeated once. If patients achieve partial remission by day 35, this regimen is repeated, except with an additional day of idarubicin on day 7. If these patients then achieve complete remission by day 70, the regimen is repeated. Patients may then undergo stem cell transplantation within 6 months of achieving complete remission. Patients who have an HLA identical sibling available receive an allogeneic transplant; others receive an autologous transplant. Patients are followed monthly for 1 year, every 3 months for 3 years, then every 6 months thereafter. PROJECTED ACCRUAL: A total of 24-60 patients will be accrued for this study.

Eligibility

Minimum Age: 15 Years

Eligible Ages: CHILD, ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Algemeen Ziekenhuis Middelheim, Antwerp, , Belgium

A.Z. St. Jan, Brugge, , Belgium

Institut Jules Bordet, Brussels, , Belgium

Universitair Ziekenhuis Antwerpen, Edegem, , Belgium

Medical School/University of Zagreb, Zagreb, , Croatia

University Hospital Rebro, Zagreb, , Croatia

Hotel Dieu de Paris, Paris, , France

Hopital Necker, Paris, , France

Ospedale San Eugenio, Rome, , Italy

Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore, Rome, , Italy

Groot Ziekengasthuis 's-Hertogenbosch, 's-Hertogenbosch, , Netherlands

Leiden University Medical Center, Leiden, , Netherlands

University Medical Center Nijmegen, Nijmegen, , Netherlands

Sint Joseph Ziekenhuis, Veldhoven, , Netherlands

Hospital Escolar San Joao, Porto, , Portugal

Ibn-i Sina Hospital, Ankara Univeristy, Ankara, , Turkey

Contact Details

Name: Petra Muus, MD, PhD

Affiliation: Universitair Medisch Centrum St. Radboud - Nijmegen

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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