Efficacy and Safety of Avatrombopag in the Treatment of Thrombocytopenia After Haplo-HSCT

Sponsor
Peking University People's Hospital
Study ID
NCT06202625
Phase
PHASE2/PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • avatrombopag — DRUG
    The avatrombopag 20mg/d will be orally taken from +D7 after haplo-HSCT until meeting the adjustment indication or to +D60 after haplo-HSCT; When PLT\<50×10\^9/L or PLT transfusion-dependent on the +D30 after haplo-HSCT, increase avatrombopag dosage to 40 mg/d; When PLT≥80×10\^9/L and without PLT transfusion within avatrombopag dosage at 40 mg/d, decrease avatrombopag dosage to 20 mg/d; When PLT≥80×10\^9/L for 7 consecutive days or PLT≥300×10\^9/L and without PLT transfusion, stop avatrombopag; When PLT\<50×10\^9/L or PLT transfusion-dependent after stopping avatrombopag , reuse avatrombopag at 40 mg/d.
  • Placebo — DRUG
    The placebo 20mg/d will be orally taken from +D7 after haplo-HSCT until meeting the adjustment indication or to +D60 after haplo-HSCT; When PLT\<50×10\^9/L or PLT transfusion-dependent on the +D30 after haplo-HSCT, increase placebo dosage to 40 mg/d; When PLT≥80×10\^9/L and without PLT transfusion within placebo dosage at 40 mg/d, decrease placebo dosage to 20 mg/d; When PLT≥80×10\^9/L for 7 consecutive days or PLT≥300×10\^9/L and without PLT transfusion, stop placebo; When PLT\<50×10\^9/L or PLT transfusion-dependent after stopping placebo, reuse placebo at 40 mg/d.

Study Details

In this study, investigators aim to evaluate the efficacy of avatrombopag in thrombocytopenic patients after haploidentical hematopoietic stem cell transplantation (haplo-HSCT) through a prospective, multi-center, double-blinded, randomized placebo-controlled clinical trial.

Key Dates

Start date
May 13, 2024
Status verified
Sep 2024
Primary completion
Oct 30, 2024
Completion
Oct 30, 2025

Study Design

Enrollment
142 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: avatrombopag
    Avatrombopag 20 mg/d will be taken orally from +D7 after haplo-HSCT until reaching the adjustment indication or to +D60 after haplo-HSCT. Routine treatment is allowed. Adjustment indication: When PLT\<50×10\^9/L or PLT transfusion dependent on the +D30 after haplo-HSCT, increase the dosage to 40 mg/d; When the dosage has been increased to 40 mg/d, and PLT≥80×10\^9/L excluding the factor of PLT transfusion, decrease the dosage to 20 mg/d; When PLT≥80×10\^9/L for 7 consecutive days excluding the factor of PLT transfusion, or PLT≥300×10\^9/L excluding the factor of PLT transfusion, stop administration; When PLT\<50×10\^9/L or become PLT transfusion dependent after stopping administration, initiate administration again at the dosage 40 mg/d. PLT transfusion Indication: When PLT\<20×10\^9/L, and/or with the symptom or risk of bleeding.
  • Placebo Comparator: Placebo
    Placebo 20 mg/d will be taken orally from +D7 after haplo-HSCT until reaching the adjustment indication or to +D60 after haplo-HSCT. Routine treatment is allowed. Adjustment indication: When PLT\<50×10\^9/L or PLT transfusion dependent on the +D30 after haplo-HSCT, increase the dosage to 40 mg/d; When the dosage has been increased to 40 mg/d, and PLT≥80×10\^9/L excluding the factor of PLT transfusion, decrease the dosage to 20 mg/d; When PLT≥80×10\^9/L for 7 consecutive days excluding the factor of PLT transfusion, or PLT≥300×10\^9/L excluding the factor of PLT transfusion, stop administration; When PLT\<50×10\^9/L or become PLT transfusion dependent after stopping administration, initiate administration again at the dosage 40 mg/d. PLT transfusion Indication: When PLT\<20×10\^9/L, and/or with the symptom or risk of bleeding.

Primary Outcome Measure

the proportion of complete response(CR) on day 60 after haplo-HSCT [ Time Frame: from randomization to day 60 after haplo-HSCT ]

Central Contacts

Related Studies