MedDataX Logo

Efficacy of G-CSF-Priming in Elderly AML Patients

NCT ID: NCT00199147

Last Updated: 2005-10-26

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Aim of the study is to compare the efficacy of intensive induction therapy with Cytarabine, Idarubicin and Etoposide (IdAV) given in parallel with (G-CSF priming) and followed by G-CSF versus the same IdAV chemotherapy only followed by G-CSF (without priming) in elderly patients with de novo AML, secondary AML and advanced MDS. Moreover, the ability to mobilize sufficient numbers of peripheral blood stem cells (PBSC) for autologous PBSC transplantation after consolidation therapy with dose-reduced FLAG-Ida chemotherapy followed by G-CSF will be evaluated.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Myeloid Leukemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cytarabine

Intervention Type DRUG

Etoposide

Intervention Type DRUG

Idarubicin

Intervention Type DRUG

G-CSF

Intervention Type DRUG

Fludarabine

Intervention Type DRUG

Stem cell apheresis

Intervention Type PROCEDURE

Stem cell transplantation

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Diagnosis of de-novo AML, FAB M0, 1, 2, 4-7 or
* Diagnosis of secondary AML after previous chemotherapy and/or radiation therapy or after preceeding MDS or
* Diagnosis of an advanced MDS, i.e. RAEB-t according to the FAB classification or
* Extramedullary AML (chloroma, "granulocytic sarcoma")
* Age greater than 60 years (not including 60 years)
* ECOG performance status 0, 1, or 2
* Written informed consent

Exclusion Criteria

* Patients with a t(15;17) translocation
* Patients with severe cardiac disease (e.g. cardiac failure NYHA III/IV, myocardial infarction within the last 6 months; severe ventricular arrythmias (Lown III or IV)
* Patients with severe complications of the leukemia such as uncontrolled bleeding, pneumonia with hypoxia or shock.
* Severe pulmonary disease (diffusion capacity for CO2 of less than 50%)
* Significant renal dysfunction (creatinine clearance \< 60/min/min)
* Bilirubin \> 2mg% (\>34.2 mmol/l)
* Patients with a clinically active second malignancy
* Patients with a psychiatric, addictive, or any disorder wich compromises ability to give truly informed consent for participating in this study
* HIV positivity
* Known refractoriness to platelet transfusion, inability to adequately substitute blood products
Minimum Eligible Age

61 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Johann Wolfgang Goethe University Hospital

OTHER

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Oliver G Ottmann, MD

Role: STUDY_CHAIR

University Hospital, Medical Department II, Frankfurt, Germany

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Hospital, Medical Department II

Frankfurt, , Germany

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Germany

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Oliver G Ottmann, MD

Role: primary

Gesine Bug, MD

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AML-elderly 01/99 Trial

Identifier Type: -

Identifier Source: org_study_id