Acalabrutinib Maleate and Bortezomib for Patients With HLA Antibodies

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorThe First Affiliated Hospital of Soochow University

About this trial

Platelet transfusion refractoriness (PTR) is a common complication in patients with hematological malignancies. It not only prolongs the duration of platelet transfusion dependence and significantly increases the risk of bleeding, but is also strongly associated with graft failure and reduced survival after transplantation. HLA class I antibody-mediated alloimmunization is recognized as the most important immunological cause of PTR. HLA antibodies are directly secreted by plasma cells, which are derived from B cells. Therefore, targeting B cells to reduce antibody production is a crucial step in eliminating HLA antibodies. Bruton's tyrosine kinase (BTK) is expressed throughout B cell development from the pre-B cell stage to maturity and supports B cell development, maturation, survival, proliferation, and antibody production by acting as a downstream kinase in the B cell receptor signaling pathway. Bortezomib, a proteasome inhibitor, can selectively induce apoptosis in long-lived plasma cells. The investigators' preliminary exploratory use of a BTK inhibitor in the treatment of PTR with HLA antibodies significantly reduced the mean fluorescence intensity (MFI) of HLA antibodies, improved platelet transfusion outcomes, and demonstrated a favorable safety profile. Based on these findings, the investigators are conducting a prospective, multicenter, randomized controlled two-arm study to investigate the efficacy and safety of acalabrutinib and bortezomib in eliminating HLA antibodies in hematological malignancies patients with PTR.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with hematological malignancies and platelet transfusion refractoriness (24-hour CCI < 4.5×10⁹/L or PPR < 20%), and with the highest MFI of HLA antibodies > 8000 ;

Age 18-65 years, both male and female;

ECOG performance status 0-3;

Expected survival > 6 months;

Disqualifiers

Hypersensitivity to acalabrutinib, bortezomib, or excipients;

Major organ bleeding (central nervous system, lung, intestines) or grade ≥3 bleeding;

Hypersplenism;

Concurrent use of drugs that may cause excessive platelet consumption (amphotericin B, vancomycin, ATG, interferon, etc.);

Trial design

Design model

Parallel

Treatments tested in this trial

  • Acalabrutinib maleate

    Drug

    100mg twice a day

  • bortezomib

    Drug

    1.3mg/m2, d1,4,8,11

  • HLA-matched or crossmatched irradiated platelets

    Other intervention

    Transfusion HLA-matched or crossmatched irradiated platelets 10U if platelet count lower than 10\*109/L

  • human immune globulin

    Drug

    0.4g/kg.d for 5 days

Treatment groups

42 Participants
are divided into 2 treatment groups
Group A: Arm AExperimental treatment 4 interventions
Group B: Arm BActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

The response rate for anti-HLA antibody clearance

Complete response: HLA antibody MFI decrease ≥30% (applied to HLA antibody loci with baseline MFI \>8000; median value used for assessment) Partial response: HLA antibody MFI decrease ≥10% and \<30% No response: HLA antibody MFI decrease \<10%, or no decrease or even an increase.

Time frame
4 weeks after intervention
2

CCI (corrected count increments)

CCI = (platelet increment per ul) x (body surface area in m2)/number of platelets transfused (x 10E11)

Time frame
4 weeks after intervention
3

PPR (percentage platelet recovery)

PPR = Post-transfusion platelet count-pre-transfusion platelet count (/L) × total blood volume × 100%

Time frame
4 weeks after intervention

Secondary outcomes

1

The incidence of bleeding events

Time frame
The study period (8 weeks after the initiation of intervention)
2

The overall survival rate

Time frame
1 year

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: