Study to Evaluate the Efficacy of Uproleselan in Combination With Chemotherapy in Chinese Patients With R/R AML
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|ClinicalTrials.gov Identifier: NCT05054543|
Recruitment Status : Recruiting
First Posted : September 23, 2021
Last Update Posted : November 24, 2021
|Condition or disease||Intervention/treatment||Phase|
|Relapsed/Refractory AML||Drug: Uproleselan Drug: Placebo||Phase 3|
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. All subjects will be followed for long-term outcomes until death or withdrawal of consent.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||140 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 3 Randomized, Double-Blinded Bridging Trial to Evaluate the Efficacy of Uproleselan Administered With Chemotherapy Versus Chemotherapy Alone in Chinese Patients With Relapsed/Refractory Acute Myeloid Leukemia|
|Actual Study Start Date :||October 18, 2021|
|Estimated Primary Completion Date :||October 2023|
|Estimated Study Completion Date :||February 2024|
Uproleselan in combination with mitoxantrone, etoposide and cytarabine (MEC) during induction; Uproleselan in combination with HiDAC/IDAC during consolidation
A rationally designed E-selectin antagonist used to inhibit binding of cells to E-selectin
Other Name: GMI-1271
Placebo Comparator: Placebo (Saline, 0.9% Sodium Chloride)
Placebo in combination with mitoxantrone, etoposide and cytarabine (MEC) during induction; Placebo in combination with HiDAC/IDAC during consolidation
0.9% Sodium Chloride
Other Name: Saline
- Overall survival [ Time Frame: 3 years ]Time from the date of randomization into the study to the date of death.
- Remission rate(rate of CR, CR/CRi and CR/CRh) [ Time Frame: Up to 60 days ]Defined as the rate of subjects who reach CR, CR/CRi and CR/CRh
- Duration of remission [ Time Frame: Up to 3 years ]Time from date of first documented remission to date of relapse or death from any cause, whichever occurs first.
- Event-free survival [ Time Frame: Up to 3 years ]Time from date of randomization into the study to the date of treatment failure, relapse, or death from any cause; whichever occurs first.
- Rate of severe oral mucositis [ Time Frame: Up to 254 days ]Incidence of severe oral mucositis experienced in patients after treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05054543
|Contact: Zhejiang CrownMab Ltd.||0571-83521933||ClinicalTrialsChina@apollomicsinc.com|
|Contact: Qian Li||0571-83521933||Qian.Li@apollomicsinc.com|
|Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College||Recruiting|
|Tianjin, Tianjin, China, 300020|
|Contact: Jianxiang Wang, Phd 022-23909120 email@example.com|
|The First Affiliated Hospital of Zhejiang University||Recruiting|
|Contact: Jie Jin, PhD 057187236685 firstname.lastname@example.org|
|Principal Investigator:||Jianxiang Wang, PhD||Institute of Hematology and Blood Diseases Hospital|