New hope for rare anemia: drug combo shows promise
NCT ID NCT04423367
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial tested a combination of two drugs, bortezomib and dexamethasone, in 18 adults with acquired pure red cell aplasia whose disease did not improve or came back after first treatment. The goal was to see if the combination could safely control the condition. The study is now complete.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- bortezomib and dexamethasone
- What this could lead to
- If successful, this combination could offer a new treatment option for people with pure red cell aplasia who did not respond to or relapsed after initial therapy.
- What could go wrong
- This is a small, early-phase trial with only 18 participants and no comparison group, so results may not apply broadly. Side effects from the drugs are possible.
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
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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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18 people
The number who actually took part.
- Started
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Sep 2020
- Finished
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Sep 2024
- 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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18 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.
Show the full entry requirements Hide 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: * ECOG ≤ 2. * Age from 18 to 70. * Diagnosed with acquired pure red cell aplasia. * Meets the criteria of first-line treatment failure or relapse. * Organs in good function. * Signed informed consent. Exclusion Criteria: * Nursing woman. * Active bacterial, virus, fungal or parasitic infection, including HIV infection, HBsAg or HBV DNA positive, HCV DNA positive, etc. * Secondary PRCA caused by lymphoproliferative disorders, including large granular lymphocytic leukemia, waldenström macroglobulinemia, small lymphocytic lymphoma/chronic lymphocytic leukemia, etc. * Secondary PRCA caused by either smoldering multiple myeloma or symptomatic multiple myeloma. * Secondary PRCA caused by either ABO major mismatched stem cell transplantation or organ transplantation. * Secondary PRCA caused by solid tumors except for thymoma. * Secondary PRCA caused by drugs or pregnancy. * Secondary PRCA caused by the B19 virus. * Have contraindications for glucocorticoids, or unable to tolerate glucocorticoids for comorbidities. * Previously received treatment in other trials within 4 weeks before enrollment. * Previously treated with the proteasome inhibitor. * Experience active hemorrhage condition, including gastrointestinal bleeding, respiratory tract bleeding and central nervous system bleeding within 2 months before enrollment or during bortezomib/dexamethasone treatment. * Have a history of malignant tumors. * Have a history of mental illness. * Inability to understand or to follow study procedures.
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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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Regenerative Medicine Center
Tianjin, China
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The Second Affilated Hospital of Shandong First Medical University
Tai’an, Shandong, China
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Zhoukou Central Hospital
Zhoukou, Henan, China
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