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A Study of XY0206 Versus Salvage Chemotherapy In Patients With Relapsed or Refractory AML With FLT3-ITD-Mutation (ALIVE)

NCT05876832 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 312

Last updated 2023-05-26

No results posted yet for this study

Summary

The purpose of this study is to determine the clinical benefit of XY0206 therapy in participants with FLT3-ITD mutated AML who are refractory to or have relapsed after prior AML therapy as shown with overall survival (OS) compared to salvage chemotherapy. In addition, this study is also to investigate the efficacy of XY0206 as assessed by CR/CRh rate in these subjects。

Conditions

  • Acute Myeloid Leukemia With FLT3/ITD Mutation

Interventions

DRUG

XY0206

Dosage form:Tablet;Multiple dose phase:Take the medicine once a day,37.5mg at a time.4 weeks of continuous medication is one course of treatment. After the first course of treatment, the subjects can continue to receive the experimental drug treatment until the subjects meet the withdrawal criteria.

DRUG

Salvage Chemotherapy

Low-dose Cytarabine (LoDAC) or azacitidine, fludarabine, cytarabine and granulocyte colony-stimulating factor (FLAG) or mitoxantrone, etoposide, cytarabine (MEC)will be administered by subcutaneous (SC) and/or intravenous (IV) injections.

Sponsors & Collaborators

  • Shijiazhuang Yiling Pharmaceutical Co. Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-15
Primary Completion
2027-07-01
Completion
2027-07-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05876832 on ClinicalTrials.gov