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Trial Title:
The Gut Microbiome in FLT3- AL Undergoing Allo-HSCT With Or Without Sorafenib Maintenance
NCT ID:
NCT05601895
Condition:
Acute Leukemia
Allogeneic Hematopoietic Stem Cell Transplantation
Conditions: Official terms:
Leukemia
Sorafenib
Conditions: Keywords:
Hematopoietic Stem Cell Transplantation
Gut Microbiome
Sorafenib
Acute Leukemia
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Drug
Intervention name:
Sorafenib
Description:
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).
Arm group label:
sorafenib group
Other name:
Nexavar
Other name:
BAY 43-9006
Other name:
BAY-673472
Other name:
BAY 545-9085
Summary:
This prospective trial investigates the effect of sorafenib maintenance therapy in FLT3
negative acute leukemia patients after allo-HSCT in terms of gut microbiome.
Detailed description:
Acute leukemia is a heterogeneous group of clonal diseases. Leukemia relapse remains the
main cause of treatment failure, including the patients undergoing allogeneic
hematopoietic stem cell transplantation (allo-HSCT). Sorafenib, an inhibitor of multiple
kinases including FLT3, has shown promising activity in FLT3-ITD-positive AML. The
investigator's previous studies demonstrated that sorafenib maintenance
post-transplantation could improve the outcomes of FLT3-ITD positive AML patients, which
was associated with sorafenib enhancing the graft-versus-leukemia (GVL) effect. Recent
studies have shown that sorafenib is also effective in patients with FLT3-negative acute
leukemia. The investigator's previous exploratory study found that salvage therapy such
as sorafenib combined with chemotherapy and donor lymphocyte infusion could significantly
improve the CR rate and survival in patients with recurrent FLT3-negative acute leukemia
after allo-HSC. More and more studies have shown that sorafenib and allo-HSCT have
synergistic GVL effect. Some studies have demonstrated that gut microbiome is associated
with graft-versus-host-disease (GVHD) and GVL. However, the exact mechanism of sorafenib
enhancing the GVL effect and the influence of gut microbiome on sorafenib maintenance
after allo-HSCT in FLT3 negative acute leukemia patients remain unknown.
Criteria for eligibility:
Study pop:
FLT3 Negative Acute Leukemia Undergoing Allo-HSCT
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- FLT3 Negative Acute Leukemia
- Allo-HSCT Recipients
Exclusion Criteria:
- intolerance to sorafenib pretransplantation
- 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 (according to the
investigators' decision)
Gender:
All
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Hematology,Nanfang Hospital, Southern Medical University
Address:
City:
Guangzhou
Zip:
510515
Country:
China
Status:
Recruiting
Contact:
Last name:
Li Xuan
Phone:
15521251270
Email:
356135708@qq.com
Start date:
October 1, 2022
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Nanfang Hospital, Southern Medical University
Agency class:
Other
Source:
Nanfang Hospital, Southern Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05601895
