New 9-Day combo shows promise for rare bone marrow disease
NCT ID NCT02203396
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a new 9-day treatment plan for people with severe aplastic anemia, a rare condition where the bone marrow stops making enough blood cells. The treatment combines three drugs (rabbit antithymocyte globulin, cyclosporine, and levamisole) to suppress the immune system and help the bone marrow recover. The goal was to see if this approach could improve blood counts and reduce side effects compared to standard therapy. Forty newly diagnosed patients took part in this phase 2 trial.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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40 people
The number who actually took part.
- Start date
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Aug 2014
- Finished
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Sep 2017
- 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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6 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: * Newly diagnosed SAA (according to the standard criteria) 1. Bone marrow cellularity less than 30% (excluding lymphocytes) 2. At least two of the following: Absolute neutrophil count less than 500/ uL; Platelet count less than 20,000/ uL; Absolute reticulocyte count less than 20,000/ uL. * Age greater than or equal to 6 years old Exclusion Criteria: * Serum creatinine greater than 2.5 mg/dL * Underlying carcinoma (except local cervical, basal cell, squamous cell) * Prior immunosuppressive therapy with ATG, antilymphocyte globulin (ALG), or high dose cyclophosphamide. * Current pregnancy or lactation or unwillingness to take oral contraceptives or use an effective method of birth control. * Diagnosis of Fanconi anemia or other congenital bone marrow failure syndromes * Evidence of a clonal disorder on cytogenetics. Patients with super severe neutropenia (ANC less than 200/uL) will not be excluded if results of cytogenetics are not available or pending. * Underlying immunodeficiency state including seropositivity for HIV * Inability to understand the investigational nature of the study or give informed consent * Moribund status or concurrent hepatic, renal, cardiac, neurologic, pulmonary, infectious, or metabolic disease of such severity that it would preclude the patient s ability to tolerate protocol therapy, or that death within 7-10 days is likely.
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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.
Contacts and locations
Locations
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Institute of Hematology & Blood Diseases Hospital Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, 300020, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Half-Matched stem cells tested as a cure for severe aplastic anemia
- Can a pill revive bone marrow in aplastic anemia?
- Can a drug revive blood cell production in children with aplastic anemia?
- Could a platelet-boosting drug shorten recovery after stem cell transplants?
- A common antioxidant may help platelets recover faster after stem cell transplant
- Could a cancer antibody reboot blood production in aplastic anemia?