Back to resultsSorafenib Maintenance for Prophylaxis of Leukemia Relapse in Allo-HSCT Recipients With FLT3 Negative Acute Leukemia
Primary Purpose
Acute Leukemia, Relapse, Hematopoietic Stem Cell Transplantation
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Sorafenib
Sponsored by
About this trial
This is an interventional treatment trial for Acute Leukemia focused on measuring Acute Leukemia, Sorafenib, Relapse, FLT3-negative, Allogeneic hematopoietic stem cell transplantation
Eligibility 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)
Sites / Locations
- Department of Hematology,Nanfang Hospital, Southern Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Sorafenib group
Non-maintenance group
Arm Description
Sorafenib will be administered at 45-60 days post-transplantation and taken for one year.
Neither sorafenib nor other FLT3 inhibitors will be used, unless the patient experiences relapse.
Outcomes
Primary Outcome Measures
Incidence of leukemia relapse
Secondary Outcome Measures
Overall survival
Leukemia-free survival
Adverse effects
Full Information
NCT ID
NCT04674345
First Posted
December 14, 2020
Last Updated
October 30, 2021
Sponsor
Nanfang Hospital, Southern Medical University
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
1. Study Identification
Unique Protocol Identification Number
NCT04674345
Brief Title
Sorafenib Maintenance for Prophylaxis of Leukemia Relapse in Allo-HSCT Recipients With FLT3 Negative Acute Leukemia
Official Title
Sorafenib Maintenance for Prophylaxis of Leukemia Relapse in Allogeneic Hematopoietic Stem Cell Transplant Recipients With FLT3 Negative Acute Leukemia
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Recruiting
Study Start Date
December 15, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanfang Hospital, Southern Medical University
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
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Leukemia, Relapse, Hematopoietic Stem Cell Transplantation
Keywords
Acute Leukemia, Sorafenib, Relapse, FLT3-negative, Allogeneic hematopoietic stem cell transplantation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
346 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sorafenib group
Arm Type
Experimental
Arm Description
Sorafenib will be administered at 45-60 days post-transplantation and taken for one year.
Arm Title
Non-maintenance group
Arm Type
No Intervention
Arm Description
Neither sorafenib nor other FLT3 inhibitors will be used, unless the patient experiences relapse.
Intervention Type
Drug
Intervention Name(s)
Sorafenib
Intervention Description
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).
Primary Outcome Measure Information:
Title
Incidence of leukemia relapse
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
1 year
Title
Leukemia-free survival
Time Frame
1 year
Title
Adverse effects
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Li Xuan
Phone
+86-020-62787883
Email
356135708@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qifa Liu
Organizational Affiliation
Nanfang Hospital, Southern Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Hematology,Nanfang Hospital, Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Xuan
Phone
+86-020-61641613
Email
356135708@qq.com
First Name & Middle Initial & Last Name & Degree
Qifa Liu
12. IPD Sharing Statement
Learn more about this trial
Sorafenib Maintenance for Prophylaxis of Leukemia Relapse in Allo-HSCT Recipients With FLT3 Negative Acute Leukemia
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