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The Gut Microbiome and Sorafenib Maintenance Therapy in FLT3-ITD Positive AML After Allo-HSCT

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Nanfang Hospital, Southern Medical University

Status

Enrolling

Conditions

Allogeneic Hematopoietic Stem Cell Transplantation
Acute Myeloid Leukemia With FLT3/ITD Mutation

Treatments

Drug: Sorafenib

Study type

Observational

Funder types

Other

Identifiers

NCT05596968
Microbiota-flt3AML-2022

Details and patient eligibility

About

This prospective trial investigates the effect of sorafenib maintenance therapy in FLT3-ITD positive AML patients after allo-HSCT in terms of gut microbiome.

Full description

Hematopoietic stem cell transplantation (HSCT) is used as a potentially curative therapy for patients with hematopoietic malignancies. Sorafenib, an inhibitor of multiple kinases including FLT3, has shown promising activity in FLT3-ITD-positive AML. Our previous studies demonstrated that sorafenib maintenance post-transplantation could improve the outcomes of FLT3-ITD-positive AML patients, which is associated with sorafenib enhancing the graft-versus-leukemia (GVL) effect. Some studies show that gut microbiome is associated with graft-versus-host-disease (GVHD) and GVL. However, the effect of gut microbiome on sorafenib maintenance after allo-HSCT remains unknown.

Enrollment

37 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • FLT3-ITD Positive AML
  • 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)

Trial design

37 participants in 1 patient group

sorafenib group
Description:
FLT3-ITD+ AML patients who receive sorafenib maintenance therapy after allo-HSCT. Sorafenib will be used from day 30 to 180 post-transplantation. 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).
Treatment:
Drug: Sorafenib

Trial contacts and locations

1

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Central trial contact

Li Xuan, MD

Data sourced from clinicaltrials.gov

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