Orelabrutinib in the Treatment of Relapsed/Refractory AIHA

ConditionAutoimmune Hemolytic Anemia (AIHA)

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-85

SponsorPeking Union Medical College Hospital

About this trial

1. wAIHA Treatment Regimen: Group A (50mg group): Orelabrutinib 50 mg, orally, once daily. After 4 weeks of treatment, if still transfusion-dependent or hemoglobin increase is \< 20 g/L, the dose may be increased to 100 mg qd. Treatment can be discontinued if ineffective at 12 weeks.

Group B (100mg group): Orelabrutinib 100 mg, orally, once daily. The treatment course is at least 12 weeks. Treatment can be discontinued if ineffective at 12 weeks. Patients who respond and tolerate the drug well may continue treatment for up to 52 weeks or longer to observe long-term efficacy and safety. 2. cAIHA Treatment Regimen: Group C (150mg group): Orelabrutinib 150 mg, orally, once daily. The treatment course is at least 12 weeks. Patients who respond and tolerate the drug well may continue treatment for up to 52 weeks or longer to observe long-term efficacy and safety.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years.

Patients with a definitive diagnosis of AIHA. wAIHA or Evans syndrome, primary or secondary to connective tissue disease (CTD) or lymphoproliferative disorder (LPD). If secondary, CTD should have no indication for treatment for other system involvement, and LPD should be in an asymptomatic, observation phase without treatment indication.

For wAIHA: No response (no partial response after 3 weeks) to full-dose glucocorticoid therapy (1-2 mg/kg/day), intolerance, or relapse (after initial response, hemoglobin drop ≥20 g/L or requiring re-initiation of immunosuppressive therapy). And hemoglobin ≤ 100 g/L.

For cAIHA: No response or relapse after anti-CD20 monoclonal antibody therapy (after initial response, hemoglobin drop ≥20 g/L or recurrence of vascular symptoms, or requiring re-initiation of immunosuppressive therapy), or unsuitable for anti-CD20 therapy. And hemoglobin ≤ 100 g/L or presence of vascular symptoms.

Disqualifiers

Active involvement of other major organs due to connective tissue disease.

Uncontrolled infection or bleeding per standard treatment.

Uncontrolled active HIV, HCV, or HBV infection per standard treatment.

Concurrent advanced uncontrolled malignancy, lymphoma.

Trial design

Design model

Parallel

Treatments tested in this trial

Orelabrutinib-50
Drug
Orelabrutinib 50 mg, orally, once daily. After 4 weeks of treatment, if still transfusion-dependent or hemoglobin increase is \< 20 g/L, the dose may be increased to 100 mg qd. Treatment can be discontinued if ineffective at 12 weeks. Stable doses of glucocorticoids (e.g., prednisone ≤ 15 mg/day) are permitted, and their tapering process should be recorded.
Orelabrutinib-100
Drug
Orelabrutinib 100 mg, orally, once daily. The treatment course is at least 12 weeks. Treatment can be discontinued if ineffective at 12 weeks. Patients who respond and tolerate the drug well may continue treatment for up to 52 weeks or longer to observe long-term efficacy and safety. Stable doses of glucocorticoids (e.g., prednisone ≤ 15 mg/day) are permitted, and their tapering process should be recorded.
Orelabrutinib-150
Drug
Orelabrutinib 150 mg, orally, once daily. The treatment course is at least 12 weeks. Patients who respond and tolerate the drug well may continue treatment for up to 52 weeks or longer to observe long-term efficacy and safety.

Treatment groups

50 Participants

are divided into 3 treatment groups

Group A: wAIHA-AExperimental treatment 1 intervention

Group B: wAIHA-BExperimental treatment 1 intervention

Group C: cAIHA-CExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

ORR

Overall Response Rate (ORR) at 12 weeks. Overall Response Rate (ORR) is defined as the proportion of patients achieving Complete Response (CR) + Partial Response (PR).

Time frame

12weeks

Secondary outcomes

The incidence of adverse events

Safety analysis includes assessing the incidence and severity of adverse events; all adverse events occurring or worsening during treatment, as well as later events considered by the investigator to be related to the study drug, will be reported.

Time frame

12weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peking Union Medical College Hospital

Lead sponsor

Source ClinicalTrials.gov

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