Refractory Poor Platelet Engraftment after Allogeneic Hematopoietic Stem Cell Transplantation
Conditions
Interventions
Treatment Group:1. Luspatercept is administered at a dose of 1.5 mg/kg subcutaneously (SC) every 3 weeks. Treatment response is assessed and dosing is adjusted after at least one treatment cycle (3 we
Sponsors
The First Affiliated Hospital of Zhejiang Chinese Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients with hematological disorders who have undergone allogeneic hematopoietic stem cell transplantation; 2. Age >= 18 years, either sex; 3. ECOG performance status 1000 ng/mL; 6. Expected survival time > 6 months; 7. Willing to participate in this clinical study and has signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Recurrence or progression of the underlying hematological disease; 2. Uncontrolled acute graft-versus-host disease; 3. Severe liver dysfunction (ALT or AST >= 3 × ULN); 4. Severe renal impairment (eGFR < 30 ml/min/1.73m^2 or end-stage renal disease patients); 5. Uncontrolled active infection or other active malignancies that may interfere with the study; 6. Cardiac disease: NYHA class 3 or higher heart failure, severe arrhythmias requiring treatment, or myocardial infarction within the past 6 months prior to screening; 7. Uncontrolled hypertension; according to NCI CTCAE v5.0, controlled hypertension in this protocol is defined as <= Grade 1; 8. Patients planning pregnancy or currently pregnant; 9. Surgical or clinical conditions that may significantly alter drug absorption, distribution, metabolism, or excretion (e.g., gastritis, ulcers, history of gastrointestinal or rectal bleeding; history of major gastrointestinal surgery).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate at 3 weeks; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to first platelet response (>= 50 × 10^9/L and >= 100 × 10^9/L).;Change from Baseline in Mean Platelet Count, Hemoglobin, and Ferritin at Week 3;Total Platelet Transfusions at Weeks 1, 3, and 6.;Proportion of Patients without Platelet Count Recurrence;Adverse Events (AEs) During and Within 30 Days After Treatment.; | — |
Countries
China
Contacts
Public ContactWu Dijiong
The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Chinese Medicine)
Outcome results
None listed