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Sorafenib for Prophylaxis of Leukemia Relapse in Allo-HSCT Recipients With FLT3-ITD Positive AML

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ClinicalTrials.gov Identifier: NCT02474290
Recruitment Status : Completed
First Posted : June 17, 2015
Last Update Posted : August 26, 2019
Sponsor:
Collaborators:
Peking University People's Hospital
Third Affiliated Hospital, Sun Yat-Sen University
Zhujiang Hospital
Xiangya Hospital of Central South University
First People's Hospital of Chenzhou
The First Affiliated Hospital of Guangzhou Medical University
Information provided by (Responsible Party):
Qifa Liu, Nanfang Hospital of Southern Medical University

Brief Summary:
The purpose of this study is to evaluate the efficacy of sorafenib for prophylaxis of leukemia relapse in allogeneic stem cell transplant (Allo-HSCT) recipients with FLT3-ITD positive acute myeloid leukemia (AML).

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

Detailed Description:
Internal tandem duplication of FMS-like tyrosine kinase 3 (FLT3-ITD) mutations have been reported in 20%-30% of patients with acute myeloid leukemia (AML). FLT3-ITD-positive AML patients have an inferior survival, primarily due to lower complete remission (CR) rate and higher relapse rate. Although allogeneic hematopoietic stem cell transplantation (allo-HSCT) improves the outcomes of some FLT3-ITD-positive AML, a significant number will suffer disease recurrence after allo-HSCT. Sorafenib, an inhibitor of multiple kinases including FLT3, has shown promising activity in FLT3-ITD-positive AML. Recent studies have shown that sorafenib monotherapy or in combination with chemotherapy are effective in attaining CR, but they do not have significant improvement in relapse. Currently, prophylactic use of sorafenib after allo-HSCT has been rarely reported, and whether it can improve outcomes of FLT3-ITD-positive AML remains unclear.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 202 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sorafenib for Prophylaxis of Leukemia Relapse in Allogeneic Hematopoietic Stem Cell Transplant Recipients With FLT3-ITD Positive Acute Myeloid Leukemia
Actual Study Start Date : June 20, 2015
Actual Primary Completion Date : July 21, 2018
Actual Study Completion Date : August 10, 2019


Arm Intervention/treatment
Experimental: Sorafenib group
Sorafenib will be used from day 30 to 180 post-transplantation.
Drug: Sorafenib
The initial dose of sorafenib is 400 mg orally twice daily and is adjusted in case of suspected toxicity or resistance (dose range, 200-800 mg daily).

No Intervention: non-Sorafenib group



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

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 3 year ]
  2. leukemia-free survival [ Time Frame: 3 year ]
  3. Incidence of side effect of sorafenib [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • FLT3-ITD Positive AML
  • Allo-HSCT Recipients

Exclusion Criteria:

  • cardiac dysfunction (particularly congestive heart failure)
  • hepatic abnormalities (bilirubin ≥ 3 mg/dL, aminotransferase> 2 times the upper limit of normal)
  • renal dysfunction (creatinine clearance rate < 30 mL/min)
  • Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
  • Patients with any conditions not suitable for the trial (investigators' decision)

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): NCT02474290


Locations
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China, Guangdong
Department of Hematology,Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China, 510515
Sponsors and Collaborators
Nanfang Hospital of Southern Medical University
Peking University People's Hospital
Third Affiliated Hospital, Sun Yat-Sen University
Zhujiang Hospital
Xiangya Hospital of Central South University
First People's Hospital of Chenzhou
The First Affiliated Hospital of Guangzhou Medical University
Investigators
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Principal Investigator: Qifa Liu Nanfang Hospital of Southern Medical University
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Qifa Liu, Professor, Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier: NCT02474290    
Other Study ID Numbers: Sorafenib-Flt3 AML-2015
First Posted: June 17, 2015    Key Record Dates
Last Update Posted: August 26, 2019
Last Verified: June 2015
Keywords provided by Qifa Liu, Nanfang Hospital of Southern Medical University:
Acute Myeloid Leukemia
FLT3-ITD
Hematopoietic Stem Cell Transplantation
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Sorafenib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action