The Safety and Efficacy of Ibrutinib in Refractory/Relapsed Autoimmune Hemolytic Anemia (NCT04398459) | Clinical Trial Compass
Active — Not RecruitingPhase 2
The Safety and Efficacy of Ibrutinib in Refractory/Relapsed Autoimmune Hemolytic Anemia
China18 participantsStarted 2020-05-01
Plain-language summary
This is an open-label, single-arm study to evaluate the safety and efficacy of Ibrutinib in subjects with refractory/relapsed autoimmune hemolytic anemia.
Who can participate
Age range
6 Years – 70 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:
* ECOG ≤ 3
* Age from 6 to 70.
* Diagnosed with WAIHA or MAIHA.
* Meets the criteria of relapsed / refractory AIHA.
* Meets the criteria of DAT-negative AIHA without any other inherited or acquired hemolytic diseases, and previously treated effectively with glucocorticoids and rituximab.
* Signed informed consent.
* Organs in good function.
Exclusion Criteria:
* Nursing woman
* Active bacterial, virus, fungal or parasitic infection, including HIV infection, HbsAg and HBV DNA positive, HCV DNA positive, etc.
* Diagnosed with cold agglutinin disease or cold agglutinin syndrome or paroxysmal cold hemoglobinuria.
* Secondary AIHA caused by drugs or infection.
* Received rituximab in 8 weeks before enrollment.
* Previously received treatment with BTK inhibitor.
* Previously received organ or stem cell transplantation.
* Have a history of thrombosis or organ infarction.
* Diagnosed with an active stage of connective tissue disease.
* Have a history of lymphoproliferative tumors or any other malignant tumors.
* Have other inherited or acquired hemolytic diseases.
* Received low-molecular-weight heparin or warfarin within 1 week before enrollment or during the Ibrutinib treatment.
* Received CYP3A4 Enzyme Inhibitors or Inducers within 1 week before enrollment or during the Ibrutinib treatment.
* Have a history of mental illness.
* Inability to understand or to follow study procedures.
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
Overall response rate
Timeframe: within 12 weeks
Trial details
NCT IDNCT04398459
SponsorInstitute of Hematology & Blood Diseases Hospital, China