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Trial record 1 of 1 for:    NCT05054543
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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
Sponsor:
Collaborator:
Zhejiang CrownMab Biotech Co. Ltd
Information provided by (Responsible Party):
Apollomics Inc.

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Relapsed/Refractory AML Drug: Uproleselan Drug: Placebo Phase 3

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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


Arm Intervention/treatment
Experimental: Uproleselan
Uproleselan in combination with mitoxantrone, etoposide and cytarabine (MEC) during induction; Uproleselan in combination with HiDAC/IDAC during consolidation
Drug: Uproleselan
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
Drug: Placebo
0.9% Sodium Chloride
Other Name: Saline




Primary Outcome Measures :
  1. Overall survival [ Time Frame: 3 years ]
    Time from the date of randomization into the study to the date of death.


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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.

  4. Rate of severe oral mucositis [ Time Frame: Up to 254 days ]
    Incidence of severe oral mucositis experienced in patients after treatment.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. ≥18 years and ≤75 years in age
  2. AML diagnosed with ≥20% myeloid marrow blasts or peripheral blood blasts per WHO criteria(2008) at the time of initial diagnosis
  3. For refractory AML, only cytarabine/daunorubicin(or Idarubicin) as can be applied repeatedly(maximal twice) as induction, no other chemotherapy are allowed to be applied Venatoclax /hypomethylation drug [HMA] can be used before and after chemotherapy.

    1. For relapse AML, it must be the first or second relapse, and remain untreated.
    2. Certain regimens (Venatoclax/HMA, Venetoclax/LDAC, HMA single agent) and FLT3 inhibitors, tyrosine kinase inhibitors, IDH1/IDH2 inhibitors or similar targeted inhibitors used alone are not considered cytotoxic chemotherapy are allowed.
  4. No more than one prior stem cell transplant
  5. Has not received the chemotherapy regimen to be used for induction on this trial
  6. Is considered medically eligible to receive the chemotherapy regimen to be used for induction on this trial

Exclusion Criteria:

  1. Patients with acute promyelocytic leukemia
  2. Acute leukemia of ambiguous lineage (biphenotypic leukemia)
  3. Chronic myeloid leukemia with myeloid blast crisis
  4. Active signs or symptoms of CNS involvement by malignancy (No lumbar puncture required)
  5. Prior use of G-CSF, CM-CSF or plerixafor within 7 days of dosing.
  6. Stem cell transplantation ≤4 months prior to dosing.
  7. Any immunotherapy or radiotherapy therapy within 28 days of dosing; any other experimental therapy or chemotherapy within 14 days of dosing
  8. Inadequate organ function.
  9. Abnormal liver function.
  10. Known active infection with hepatitis A, B, or C, or human immunodeficiency virus.
  11. Moderate kidney dysfunction (glomerular filtration rate <45 mL/min).
  12. Uncontrolled acute life-threatening bacterial, viral, or fungal infection.
  13. Clinically significant cardiovascular disease.
  14. Major surgery within 4 weeks of dosing.

Information from the National Library of Medicine

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


Contacts
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Contact: Zhejiang CrownMab Ltd. 0571-83521933 ClinicalTrialsChina@apollomicsinc.com
Contact: Qian Li 0571-83521933 Qian.Li@apollomicsinc.com

Locations
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China, Tianjin
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    wangjx@medmail.com.cn   
China
The First Affiliated Hospital of Zhejiang University Recruiting
Hangzhou, China
Contact: Jie Jin, PhD    057187236685    jiej0503@zju.edu.cn   
Sponsors and Collaborators
Apollomics Inc.
Zhejiang CrownMab Biotech Co. Ltd
Investigators
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Principal Investigator: Jianxiang Wang, PhD Institute of Hematology and Blood Diseases Hospital
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Responsible Party: Apollomics Inc.
ClinicalTrials.gov Identifier: NCT05054543    
Other Study ID Numbers: APL-106-02
First Posted: September 23, 2021    Key Record Dates
Last Update Posted: November 24, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Apollomics Inc.:
AML