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Rabbit antibodies show promise for rare bone marrow disease

NCT ID NCT00471848

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 This study
The trial has finished. Results may not be published yet.
Stopped early
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This status has not been confirmed recently, so it may be out of date.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 phase 2 trial tested a combination of rabbit antithymocyte globulin (Thymoglobuline) and ciclosporin in 35 people with acquired aplastic anemia, a condition where the bone marrow stops making enough blood cells. The goal was to see if this rabbit-based immune-suppressing treatment could improve blood counts and reduce the need for transfusions. Results were compared to historical data from patients who received a similar treatment made from horse antibodies.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
rabbit antithymocyte globulin (Thymoglobuline) with ciclosporin
What this could lead to
If successful, this could offer an alternative first-line immune-suppressing treatment for people with aplastic anemia, potentially improving blood cell counts and reducing transfusion needs.
What could go wrong
This is a small, early-phase study (35 participants) with no control group, so results are preliminary. The treatment involves strong immune suppression, which carries risks like infection and allergic reactions.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

35 people

The number who actually took part.

Start date

Aug 2008

Finished

Feb 2013

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

16 years and older

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: 1. Must fulfil definition of aplastic anaemia: There must be at least two of the following: * haemoglobin \< 10g/dl * platelet count \< 50 x 109/l * neutrophil count \< 1.5 x 109/l, and a hypocellular bone marrow on bone marrow biopsy SAA as defined by a hypocellular bone marrow of \<25% cellularity and two of the following: * neutrophil count \< 0.5 x 109/l * platelets \< 20 x 109/l * reticulocytes \< 20 x 109/l NSAA as defined by a hypocellular bone marrow and cytopenia in at least two cell lines and neutrophil count \> 0.5 x 109/l, and red cell and/or platelet transfusion dependence 2. Have acquired aplastic anaemia 3. Time from diagnosis to study registration maximum 6 months 4. No prior treatment except for haemopoietic growth factors given for no more than four weeks, and androgens 5. Age minimum 16 years with no upper age limit Exclusion Criteria: 1. Eligibility for an human leukocyte antigens (HLA)-matched sibling donor transplant for SAA patients 2. Prior therapy with ATG or CSA 3. Haematopoeitic growth factors more than 4 weeks before study enrolment 4. Diagnosis of Fanconi anaemia, dyskeratosis congenita or congenital bone marrow failure syndrome 5. Evidence of myelodysplastic disease 6. Paroxysmal nocturnal haemoglobinuria with evidence of significant haemolysis, history of Paroxysmal Nocturnal Hemoglobinuria (PNH) associated thrombosis or a PNH clone \>50% by flow cytometry 7. Diagnosis or previous history of carcinoma (except local cervical, basal cell, squamous cells, or melanoma) 8. Subject is pregnant (e.g. positive Human Chorionic Gonadotropin (HCG) test) or is breast feeding 9. Severe uncontrolled infection or unexplained fever \>38 degrees Celsius 10. Subjects who have hepatic, renal cardiac, metabolic or other concurrent diseases of such severity that life expectancy is less than 3 months

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Conditions

The condition(s) this trial relates to.

acquired aplastic anemia aplastic anemia

As listed by the trial registrant

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

Aplastic anemia

Contacts and locations

Locations

  • Addenbrooke's Hospital

    Cambridge, United Kingdom

  • Henri Mondor Hospital

    Créteil, France

  • Hopital St. Louis

    Paris, 75475, France

  • King Faisal Specialist Hospital & Research Cnetre

    Riyadh, Saudi Arabia

  • King's College Hospital

    London, United Kingdom

  • Medical University Hannover

    Hanover, Germany

  • Nottingham Universitry Hospital Trust

    Nottingham, United Kingdom

  • Ospedale San Martino

    Genova, 16132, Italy

  • Royal Bournemouth

    Bournemouth, United Kingdom

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

    London, Sw17 0RE, United Kingdom

  • University Hospital

    Basel, 4031, Switzerland

  • University Hospital Eppendorf

    Hamburg, Germany

  • University Hospital Essen

    Essen, Germany

  • Universitätsklinikum - Institut für klinische Transfusionsmedizin

    Ulm, 89081, Germany

More trials for these conditions

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