This bridging study will evaluate the efficacy of uproleselan, a specific E-selectin antagonist, in combination with chemotherapy to treat Chinese relapsed/refractory AML patients, compared to chemotherapy alone. The safety of uproleselan when given with chemotherapy will also be investigated in patients with relapsed/refractory AML
This trial will enroll approximately 140 randomized subjects 18 through 75 years of age at the time of randomization with primary refractory AML or relapsed AML (first or second untreated relapse) and eligible to receive induction chemotherapy as described. Randomization will be done at trial entry at a 1:1 ratio, and will be stratified by age (\<60, ≥60 years) and disease status (primary refractory/early relapse ≤6 months, late relapse\>6 months) and prior HSCT status. Treatment assignment received at randomization will be maintained during all induction and consolidation cycles. This trial will have the following sequential phases: screening, baseline, induction treatment and count recovery, response assessment, consolidation treatment (if remission is achieved), and follow-up for relapse and survival assessment. Subjects not achieving remission will continue to be followed for long-term trial endpoints such as disease progression and survival. Blinding will be maintained until database lock. This study will carry out long-term follow-up for all subjects for a maximum of 3 years or death of subjects or withdrawal of consent.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
140
A rationally designed E-selectin antagonist used to inhibit binding of cells to E-selectin
0.9% Sodium Chloride
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital of Zhejiang University
Hangzhou, China
Overall survival
Time from the date of randomization into the study to the date of death.
Time frame: 3 years
Remission rate(rate of CR, CR/CRi and CR/CRh)
Defined as the rate of subjects who reach CR, CR/CRi and CR/CRh
Time frame: Up to 60 days
Duration of remission
Time from date of first documented remission to date of relapse or death from any cause, whichever occurs first.
Time frame: Up to 3 years
Event-free survival
Time from date of randomization into the study to the date of treatment failure, relapse, or death from any cause; whichever occurs first.
Time frame: Up to 3 years
Rate of severe oral mucositis
Incidence of severe oral mucositis experienced in patients after treatment.
Time frame: Up to 254 days
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