A Single-arm Phase 2 Prospective Clinical Study of Linprixel in the Treatment of Relapsed/Refractory Autoimmune Hemolytic Anemia

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorPeking Union Medical College Hospital

About this trial

wAIHA or EVANS syndrome: Linpriril 40mg, oral, once daily. The therapeutic effect will be evaluated after 4 weeks. If the therapeutic effect does not reach the PR, the dose will be increased to 60mg once a day. After continuing to take it for 4 weeks, the therapeutic effect will be evaluated again. If the PR is not reached, it can be increased to 80mg. If the PR is still not reached after continuing to take it for 4 weeks, it will be discontinued (for a total of 12 weeks). The initial dose is 40mg, taken orally once a day. If the therapeutic effect reaches PR or above after 4 weeks, continue taking this dose. The evaluation is the same as before every 4 weeks. The research period was 12 weeks. The duration of continuous treatment for effective patients is determined by the researchers, and the dosage of the drug can be reduced or increased.

cAIHA: Linpriril 80mg, oral administration, once daily. The therapeutic effect was evaluated every 4 weeks. The research period was 12 weeks. The treatment was discontinued if the therapeutic effect did not reach the PR within 12 weeks. The duration of continuous treatment for effective patients is determined by the researchers, and the dosage of the drug can be reduced or increased.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Those with incomplete functions of organs such as the heart, liver and lungs; Patients with acute renal insufficiency

Combined with connective tissue diseases, other vital organs are involved.

Uncontrolled infection or bleeding after standard treatment. Standard treatment for uncontrolled active infections of HIV, HCV or HBV.

Combined with advanced uncontrolled malignant tumors and lymphomas.

Trial population

1. Record complete demographic data, improve the patient's medical history and physical examination. 2. Routine examinations include blood routine (including reticulocytes), biochemistry (liver and kidney function, lactate dehydrogenase, ferritin, folic acid, vitamin B12), coagulation function, direct anti-human globulin test (DAT) and typing, colagglutinin test, autoantibody, antiphospholipid antibody, immunoglobulin, serum protein electrophoresis, and TB cell subset analysis. Cytokines (flow cytometry), chest and abdominal CT or abdominal ultrasound. 3. Bone Marrow smear, biopsy, flow immunotyping, chromosome (optional)

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Parsaclisib

    Drug

    parsaclisib 40mg qd

Treatment groups

22 Participants
are divided into 1 treatment group
Group A: parsaclisib 40mg qd1 intervention

Trial outcomes

Primary outcomes

1

The overall response rate (ORR) at 12 weeks

The overall response rate (ORR)

Time frame
12 weeks
2

The complete response rate (CRR) at 12 weeks

The complete response rate (CRR) at 12 weeks

Time frame
12 weeks

Secondary outcomes

1

The incidence of adverse events

The incidence of adverse events

Time frame
12 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

This trial is not recruiting at the moment. You can still explore other options: