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Efficacy of 5-azacytidine Added to Standard Primary Therapy in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)

NCT00915252 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 214

Last updated 2012-12-17

No results posted yet for this study

Summary

The primary purpose of the study is to determine, whether the addition of 5-azacytidine to standard chemotherapy in elderly patients with newly diagnosed AML improves treatment results (event free survival).

Conditions

Interventions

DRUG

azacitidine

Starting dose has been determined during run-in dose finding part of the study. Starting dose of the interventional drug is 75 mg/m²/d. Application form: During induction therapy phase: i.v. on days -5--1 before standard chemotherapy for 1 or 2 cycles, During consolidation therapy: s.c. on days -5--1 before standard chemotherapy (2 cycles). During maintenance therapy: s.c. on days 1-5 on a 28day cycle till maximum one year after start of first induction therapy.

DRUG

standard chemotherapy (7+3 scheme): Daunorubicin, Cytarabine

Induction therapy: Daunorubicin 60mg/m²/d i.v.on days 3,4,5 AraC 100mg/m²/d i.v. on days 1-7 Consolidation therapy: AraC 1g/m² twice a day on day 1,3,5

Sponsors & Collaborators

  • Celgene Corporation

    collaborator INDUSTRY

  • Amgen

    collaborator INDUSTRY

  • University Hospital Muenster

    lead OTHER

Principal Investigators

  • Carsten Müller-Tidow, MD · Universitätsklinikum Münster, Medizinische Klinik A

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
61 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • Germany

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00915252 on ClinicalTrials.gov