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New combo therapy for rare blood disorder shows promise

NCT ID NCT01163942

Disease control Sponsor: European Society for Blood and Marrow Transplantation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether adding a drug called G-CSF to the usual treatment (ATG and Cyclosporin A) helps people with newly diagnosed severe aplastic anemia. Severe aplastic anemia is a rare condition where the bone marrow stops making enough blood cells. The trial included 205 participants and measured survival, blood cell recovery, and infections. The study was stopped early, but the results help doctors understand the best way to manage this serious disease.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

205 people

The number who actually took part.

Start date

Mar 2001

Finished

Nov 2010

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 to 90 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Severe or very severe aplastic anemia * Less than 6 months from diagnosis of severe aplastic anemia by bone marrow biopsy * Ethical - Before randomization is done the subject or legally acceptable representative must give written informed consent for participation in the study Exclusion Criteria: * Eligibility for an HLA-matched sibling donor transplant * Prior therapy with ATG * Cyclosporin A \<4 weeks before enrollment * Treatment with G-CSF \<2 weeks before enrollment * Other growth factors \<4 weeks before enrollment * Diagnosis of Fanconi anemia, dyskeratosis congenita or congenital bone marrow failure syndrome * Evidence of myelodysplastic disease * Diagnosis or previous history of carcinoma (except local cervical, basal cell, squamous cells, or melanoma) * Subjects who have infection, hepatic, renal cardiac, metabolic or other concurrent diseases of such severity that death is imminent * Subject is pregnant (e.g. positive HCG test) or is breast feeding

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Conditions

The condition(s) this trial relates to.

aplastic anemia idiopathic aplastic anemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Aplastic anaemia

Contacts and locations

Locations

  • Asklepios Klinik Altona

    Hamburg, Germany

  • Athens General Pediatric Hospital

    Athens, Greece

  • Avicenne Hospital

    Bobigny, France

  • Benjamin Franklin Hospital

    Berlin, Germany

  • Bretonneau Hospital

    Tours, France

  • Bristol Haematology & Oncology Centre

    Bristol, United Kingdom

  • Brüderkrankenhaus St. Josef

    Paderborn, Germany

  • CHU Angers

    Angers, France

  • CHU Caremeau

    Nîmes, France

  • CHU Clemenceau

    Caen, France

  • CHU Limoges

    Limoges, France

  • CHU Montpellier

    Montpellier, France

  • CHU Reims

    Reims, France

  • CHU Toulouse

    Toulouse, France

  • CHU de Caen

    Caen, France

  • Charite Hospital

    Berlin, Germany

  • Deutsche Klinik für Diagnostik

    Wiesbaden, Germany

  • Erasmus MC

    Rotterdam, Netherlands

  • Evangelisches Krankenhaus Diakonie

    Bremen, Germany

  • Evangelisches Waldkrankenhaus

    Berlin, Germany

  • G. Roussy Institute

    Villejuf, France

  • Gaslini Children's Hospital

    Genova, Italy

  • Groningen University Hospital

    Groningen, Netherlands

  • Hannover Medical School

    Hanover, Germany

  • Harlachin

    München, Germany

  • Heartlands Hospital

    Birmingham, United Kingdom

  • Helios Klinikum Wuppertal

    Wuppertal, Germany

  • Henri Mondor

    Créteil, France

  • Hopitaux Universitaires de Geneve

    Geneva, Switzerland

  • Huddinge University Hospital

    Stockholm, Sweden

  • Klinikum Ernst von Bergmann

    Potsdam, Germany

  • Klinikum Nord

    Nuremberg, Germany

  • Klinikum Oldenburg

    Oldenburg, Germany

  • Klinikum Stuttgart

    Stuttgart, Germany

  • Klinkum Rechts der Isar

    München, Germany

  • Krakenhaus München Schwabing

    München, Germany

  • Leiden University Medical Centre

    Leiden, Netherlands

  • Lund Unversity

    Lund, Sweden

  • Marien Hopistal

    Hagen, Germany

  • Monklands Hospital

    Airdrie, United Kingdom

  • Paoli-Calmettes Institute

    Marseille, France

  • Royal Cornwall Hospitals

    Cornwall, United Kingdom

  • San Martino

    Genova, Italy

  • San Raffaele Hospital

    Milan, Italy

  • Sana Klinikum

    Lübeck, Germany

  • St George's Hospital/ St George's University of London

    London, Sw17 0RE, United Kingdom

  • St. Antoine

    Paris, France

  • St. Bartholomew's Hospital

    London, United Kingdom

  • St. Johannes-Hospital

    Duisburg, Germany

  • St. Louis Hospital

    Paris, France

  • The Leeds Teaching Hospitals

    Leeds, United Kingdom

  • University Clinic Tübingen

    Tübingen, Germany

  • University Hospital

    Pilsen, Czechia

  • University Hospital

    Brest, France

  • University Hospital

    Cologne, Germany

  • University Hospital

    Frankfurt, Germany

  • University Hospital

    Halle, Germany

  • University Hospital

    Heidelberg, Germany

  • University Hospital

    Regensburg, Germany

  • University Hospital

    Rostock, Germany

  • University Hospital

    Wiesbaden, Germany

  • University Hospital

    Pátrai, Greece

  • University Hospital

    Padova, Italy

  • University Hospital

    Basel, Switzerland

  • University Hospital Carl Gustav Carus

    Dresden, Germany

  • University Hospital Georg August

    Göttingen, Germany

  • University Hospital Heinrich Heine

    Düsseldorf, Germany

  • University Hospital Ulm

    Ulm, Germany

  • Universitäts Klinikum

    Ludwigshaven, Germany

  • Universitätsklinik

    Essen, Germany

  • Wishaw General

    Wishaw, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.