New study: which first treatment works best for severe aplastic anemia?
NCT ID NCT07338422
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares two first-line treatments for severe aplastic anemia, a condition where the bone marrow stops making enough blood cells. One treatment is a stem cell transplant from a half-matched donor, and the other is drug therapy that suppresses the immune system. The study will follow 116 people aged 14 to 70 to see which approach leads to better survival and recovery, while also tracking side effects like infections and graft-versus-host disease.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 116 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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14 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * (1) Confirmed diagnosis of severe aplastic anemia, including very severe aplastic anemia, severe aplastic anemia, and hepatitis-associated severe aplastic anemia. (2) Age 14-70 years. (3) No HLA-matched related donor available. (4) HIV negative, HBV negative, HCV negative. (5) No absolute contraindications to transplantation or immunosuppressive therapy. (6) Signed informed consent form must be obtained before study procedures begin; for subjects aged 18 years or older, informed consent shall be signed by the patient themselves or direct family members. Considering the patient's medical condition, if the patient's own signature is medically inadvisable, the informed consent shall be signed by a legal guardian or the patient's direct family member. Exclusion Criteria: 1. Inherited bone marrow failure syndromes (IBMFS), including Fanconi anemia, dyskeratosis congenita, Shwachman-Diamond syndrome (SDS), etc.; 2. Clonal cytogenetic abnormalities or bone marrow examination suggesting pre-MDS or MDS; 3. Known severe allergy to ATG; 4. Previous allogeneic or autologous hematopoietic stem cell transplantation; 5. Previous solid organ transplantation; 6. Uncontrolled infection at enrollment, or requiring mechanical ventilation or hemodynamic instability; 7. Active HIV replication at enrollment, detectable HCV antibody positivity and HCV-RNA positivity within 90 days prior to enrollment, or HBsAg positivity; known seropositivity for HIV or active hepatitis C virus; 8. History of malignant tumors (except resected basal cell carcinoma or treated cervical carcinoma in situ); 9. Psychiatric disorders or other conditions that prevent compliance with study treatment and monitoring requirements; 10. Inability or unwillingness to sign the consent form; 11. Other special circumstances deemed ineligible by the investigator.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Half-Matched stem cell transplants tested as a cure path for older aplastic anemia patients
- New hope for older adults with rare blood disorder: safer transplant regimen under study
- New combo therapy for rare blood disorder shows promise
- Double stem cell transplant could be Game-Changer for rare blood disorder
- New study aims to tame harsh side effects of aplastic anemia therapy
- New transplant recipe may tame severe anemia