Randomized Study In Severe Aplastic Anemia Patients Receiving Atg, Cyclosporin A, With Or Without… (NCT01163942) | Clinical Trial Compass
TerminatedPhase 3
Randomized Study In Severe Aplastic Anemia Patients Receiving Atg, Cyclosporin A, With Or Without G-CSF (SAA-G-CSF)
Stopped: Ceased production of the study drug, Lymphoglobulin. Recruitment of patients onto the trial was too slow.
Czechia, France, Germany205 participantsStarted 2001-03
Plain-language summary
The purpose of this study is to examine the effect of G-CSF on disease free survival and overall survival in aplastic anaemia patients who also receive ATG and Cyclosporin A.
Who can participate
Age range
2 Years – 90 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:
* 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
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
Failure free survival
Timeframe: day 240
Trial details
NCT IDNCT01163942
SponsorEuropean Society for Blood and Marrow Transplantation