Treatment With Olverembatinib in CML-CP Patients Who Failed to at Least Two Previously Administered Second-generation TKIs.

Last updated: July 26, 2022
Sponsor: Shenzhen Second People's Hospital
Overall Status: Active - Recruiting

Phase

3

Condition

Leukemia

Treatment

N/A

Clinical Study ID

NCT05311943
OLV20220331
  • Ages 18-75
  • All Genders

Study Summary

The purpose of this trial is to evaluate the efficacy and safety of olverembatinib(HQP1351) in patients with chronic myeloid leukemia in chronic phase (CML-CP) who are resistant and/or intolerant to at least two second-generation tyrosine kinase inhibitors. The efficacy of olverembatinib is determined by evaluating the major molecular responses(MMR) at the and of 12 months.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥ 18 years and ≤75 years.
  • Diagnosis of CML-CP.
  • ECOG performance of 0-2.
  • Adequate end organ function defined as the following: total bilirubin <1.5xULN, SGPT <2.5x ULN, creatinine <1.5x ULN.
  • Resistance and/or intolerance of at least two second-generation TKIs.
  • Patients must sign an informed consent form (ICF) indicating they are aware of theinvestigational nature of this study, in keeping with the policies of the hospital.

Exclusion

Exclusion Criteria:

  • Known to be allergic to study drug ingredients or their analogues.
  • History of undergone major surgery within 4 weeks.
  • Patients unwilling or unable to comply with the protocol.
  • Pregnant or breast-feeding patients.
  • patients with other malignant tumor.

Study Design

Total Participants: 40
Study Start date:
July 01, 2022
Estimated Completion Date:
June 30, 2025

Connect with a study center

  • Shenzhen Second People's Hospital

    Shenzhen, Guangdong 518035
    China

    Active - Recruiting

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