Acalabrutinib maleate
Drug100mg twice a day
NCT Number: NCT07635511
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.
Trial opening soon.
Get Notified18 year–65 year
All sexes
Interventional
Phase 3
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
100mg twice a day
1.3mg/m2, d1,4,8,11
Transfusion HLA-matched or crossmatched irradiated platelets 10U if platelet count lower than 10*109/L
0.4g/kg.d for 5 days
Time frame: 4 weeks after intervention
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
CCI = (platelet increment per ul) x (body surface area in m2)/number of platelets transfused (x 10E11)
Time frame: 4 weeks after intervention
PPR = Post-transfusion platelet count-pre-transfusion platelet count (/L) × total blood volume × 100%
Time frame: The study period (8 weeks after the initiation of intervention)
Time frame: 1 year
Contact information is provided by the study sponsor or research team.
Xuefeng He
CONTACT
Yaqiong Tang
CONTACT
The First Affiliated Hospital of Soochow University
Other
Acalabrutinib Maleate Monotherapy or in Combination With Bortezomib for Eliminating HLA Antibodies in Patients With Hematologic Malignancies and Platelet Transfusion Refractoriness: a Multicenter, Randomized Controlled Study
Acronym: AB-HLA-2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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