NCT04674345

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
346

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2020

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 14, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

December 15, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 19, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

November 8, 2021

Status Verified

December 1, 2020

Enrollment Period

2 years

First QC Date

December 14, 2020

Last Update Submit

October 30, 2021

Conditions

Acute LeukemiaRelapseHematopoietic Stem Cell Transplantation

Keywords

Acute LeukemiaSorafenibRelapseFLT3-negativeAllogeneic hematopoietic stem cell transplantation

Outcome Measures

Primary Outcomes (1)

  • Incidence of leukemia relapse

    1 year

Secondary Outcomes (3)

  • Overall survival

    1 year

  • Leukemia-free survival

    1 year

  • Adverse effects

    1 year

Study Arms (2)

Sorafenib group

EXPERIMENTAL

Sorafenib will be administered at 45-60 days post-transplantation and taken for one year.

Drug: Sorafenib

Non-maintenance group

NO INTERVENTION

Neither sorafenib nor other FLT3 inhibitors will be used, unless the patient experiences relapse.

Interventions

SorafenibDRUG

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).

Sorafenib group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Hematology,Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

RECRUITING

MeSH Terms

Conditions

Recurrence

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylurea CompoundsUreaAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsNiacinamideNicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Qifa Liu

    Nanfang Hospital, Southern Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Li Xuan

CONTACT

+86-020-62787883356135708@qq.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 14, 2020

First Posted

December 19, 2020

Study Start

December 15, 2020

Primary Completion

December 31, 2022

Study Completion

December 31, 2023

Last Updated

November 8, 2021

Record last verified: 2020-12

Locations

CN(1)