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A Study of SKLB1028 Versus Salvage Chemotherapy in Patients With Relapsed or Refractory (R/R) AML With FLT3-Mutated

NCT04716114 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 315

Last updated 2021-11-02

No results posted yet for this study

Summary

This is a randomized，multicenter, open-label Phase III, clinical study to confirm the efficacy and safety of SKLB1028 in patients with relapsed or refractory(R/R) FLT3-Mutated Acute Myeloid Leukemia（AML）compared to salvage chemotherapy.

Conditions

  • Acute Myeloid Leukemia (AML)

Interventions

DRUG

SKLB1028

SKLB1028 will be administered by oral capsules, 150 mg twice daily (BID).

DRUG

Salvage Chemotherapy

Low-dose cytarabine (LoDAC); azacytidine; homoharringtonine (HHT), cytarabine and aclarubicin (HAA) or fludarabine, cytarabine and granulocyte colony-stimulating factor (FLAG) will be administered by subcutaneous (SC) and/or intravenous (IV) injections.

Sponsors & Collaborators

  • CSPC ZhongQi Pharmaceutical Technology 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
2021-03-24
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • China

Study Locations

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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 NCT04716114 on ClinicalTrials.gov