Rabbit Antithymocyte Globulin (Thymoglobuline) With Ciclosporin for Patients With Acquired Aplast… (NCT00471848) | Clinical Trial Compass
CompletedPhase 2
Rabbit Antithymocyte Globulin (Thymoglobuline) With Ciclosporin for Patients With Acquired Aplastic Anaemia
France, Germany, Italy35 participantsStarted 2008-08
Plain-language summary
To assess the tolerability and effectiveness of rabbit antithymocyte globulin (ATG, Thymoglobuline) with ciclosporin in the first line treatment of patients with acquired severe aplastic anaemia, and patients with non-severe aplastic anaemia and who are transfusion dependent.
Who can participate
Age range
16 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Must fulfil definition of aplastic anaemia:
. Have acquired aplastic anaemia
. Time from diagnosis to study registration maximum 6 months
. No prior treatment except for haemopoietic growth factors given for no more than four weeks, and androgens
. Age minimum 16 years with no upper age limit
Exclusion criteria
. Eligibility for an human leukocyte antigens (HLA)-matched sibling donor transplant for SAA patients
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants With Response to Rabbit Antithymocyte Globulin (Thymoglobuline)
Timeframe: at 6months
Trial details
NCT IDNCT00471848
SponsorEuropean Society for Blood and Marrow Transplantation
. Haematopoeitic growth factors more than 4 weeks before study enrolment
. Diagnosis of Fanconi anaemia, dyskeratosis congenita or congenital bone marrow failure syndrome
. Evidence of myelodysplastic disease
. Paroxysmal nocturnal haemoglobinuria with evidence of significant haemolysis, history of Paroxysmal Nocturnal Hemoglobinuria (PNH) associated thrombosis or a PNH clone \>50% by flow cytometry
. Diagnosis or previous history of carcinoma (except local cervical, basal cell, squamous cells, or melanoma)
. Subject is pregnant (e.g. positive Human Chorionic Gonadotropin (HCG) test) or is breast feeding