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Sorafenib Maintenance for Prophylaxis of Leukemia Relapse in Allo-HSCT Recipients With FLT3 Negative Acute Leukemia

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ClinicalTrials.gov Identifier: NCT04674345
Recruitment Status : Recruiting
First Posted : December 19, 2020
Last Update Posted : November 8, 2021
Sponsor:
Collaborators:
Peking University People's Hospital
Xiangya Hospital of Central South University
Zhujiang Hospital
Third Affiliated Hospital, Sun Yat-Sen University
First People's Hospital of Chenzhou
The First Affiliated Hospital of Guangzhou Medical University
The Third Xiangya Hospital of Central South University
Second Affiliated Hospital, Sun Yat-Sen University
The Seventh Affiliated Hospital of Sun Yat-sen University
Information provided by (Responsible Party):
Qifa Liu, Nanfang Hospital of Southern Medical University

Study Description
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Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of sorafenib maintenance after allo-HSCT in FLT3-negative acute leukemia patients.

Condition or disease Intervention/treatment Phase
Acute Leukemia Relapse Hematopoietic Stem Cell Transplantation Drug: Sorafenib Phase 2 Phase 3

Detailed Description:
Sorafenib is a multikinase inhibitor that blocks multiple pathways involved in the development and progression of acute leukemia, such as FLT3-ITD, the RAS and RAF gene families, KIT, and the VEGF and PDGF receptors. Recently, two back-to-back randomized controlled trials both reveal that sorafenib maintenance after allo-HSCT could prevent relapse in patients with FLT3-ITD AML, resulting in a survival benefit. Sorafenib has also been explored in the treatment of acute leukemia without FLT3 mutations and shown promising results. Currently, relapse remains the major cause of transplant failure, especially for high-risk and refractory acute leukemia patients. Once patients relapse after allo-HSCT, the prognosis is dismal. Therefore, prevention of relapse is of great importance to improve the prognosis. Based on the current research status, we plan to conduct a prospective, multicenter, phase 2 randomized controlled trial to explore the efficacy and safety of sorafenib maintenance after allo-HSCT in FLT3-negative acute leukemia patients.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 346 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sorafenib Maintenance for Prophylaxis of Leukemia Relapse in Allogeneic Hematopoietic Stem Cell Transplant Recipients With FLT3 Negative Acute Leukemia
Actual Study Start Date : December 15, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia
Drug Information available for: Sorafenib

Arms and Interventions
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Arm Intervention/treatment
Experimental: Sorafenib group
Sorafenib will be administered at 45-60 days post-transplantation and taken for one year.
 Drug: Sorafenib
The initial dose of sorafenib is 400 mg orally twice daily and is adjusted in case of suspected toxicity (dose range, 200-800 mg daily).
No Intervention: Non-maintenance group
Neither sorafenib nor other FLT3 inhibitors will be used, unless the patient experiences relapse.


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of leukemia relapse [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 1 year ]
  2. Leukemia-free survival [ Time Frame: 1 year ]
  3. Adverse effects [ Time Frame: 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with FLT3-negative acute leukemia undergoing first allo-HSCT
  • Age 18 to 65 years old with ECOG performance status 0-2
  • Hematopoietic recovery within 60 days post-transplantation
  • Sign informed consent form, have the ability to comply with study and follow-up procedures

Exclusion Criteria:

  • Acute promyelocytic leukemia (AML subtype M3)
  • Acute leukemia with FLT3-ITD or FLT3-TKD mutations
  • Philadelphia-positive acute lymphoblastic leukemia
  • Chronic myelogenous leukemia with blast crisis
  • Intolerance to sorafenib pre-transplantation
  • Life expectancy less than 30 days post-transplantation
  • Active aGVHD or uncontrolled infections within 60 days post-transplantation
  • Cardiac dysfunction (particularly congestive heart failure, unstable coronary artery disease and serious cardiac ventricular arrhythmias requiring antiarrhythmic therapy)
  • Respiratory failure ( PaO2 ≤60mmHg)
  • Hepatic abnormalities (total bilirubin ≥3 mg/dL, aminotransferase >2 times the upper limit of normal)
  • Renal dysfunction (creatinine clearance rate < 30 mL/min)
  • ECOG performance status 3, 4 or 5
  • With any conditions not suitable for the trial (investigators' decision)
Contacts and Locations
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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): NCT04674345


Contacts
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Contact: Li Xuan +86-020-62787883 356135708@qq.com

Locations
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China, Guangdong
Department of Hematology,Nanfang Hospital, Southern Medical University Recruiting
Guangzhou, Guangdong, China, 510515
Contact: Li Xuan    +86-020-61641613    356135708@qq.com   
Principal Investigator: Qifa Liu         
Sponsors and Collaborators
Nanfang Hospital of Southern Medical University
Peking University People's Hospital
Xiangya Hospital of Central South University
Zhujiang Hospital
Third Affiliated Hospital, Sun Yat-Sen University
First People's Hospital of Chenzhou
The First Affiliated Hospital of Guangzhou Medical University
The Third Xiangya Hospital of Central South University
Second Affiliated Hospital, Sun Yat-Sen University
The Seventh Affiliated Hospital of Sun Yat-sen University
Investigators
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Principal Investigator: Qifa Liu Nanfang Hospital of Southern Medical University
More Information
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Responsible Party: Qifa Liu, Professor, Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier: NCT04674345    
Other Study ID Numbers: Sorafenib-Non-Flt3 AL-2020
First Posted: December 19, 2020    Key Record Dates
Last Update Posted: November 8, 2021
Last Verified: December 2020

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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 Qifa Liu, Nanfang Hospital of Southern Medical University:
Acute Leukemia
Sorafenib
Relapse
FLT3-negative
Allogeneic hematopoietic stem cell transplantation
Additional relevant MeSH terms:
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Leukemia
Recurrence
Acute Disease
Neoplasms by Histologic Type
Neoplasms
Disease Attributes
 Pathologic Processes
Sorafenib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action