A Phase Ⅰb/Ⅱ Clinical Study of Clifutinib Besylate Combined With Chemotherapy in the Treatment of Newly Diagnosed AML

NCT05133882 | Recruiting Phase 1

• 1 other identifier: PCD-DHEC73543-16-002
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multi-center open clinical study aimed at evaluating the efficacy and safety of Clifutinib Besylate combined with chemotherapy in newly-treated adult subjects with AML

Conditions

Acute Myeloid Leukemia, Adult

Outcome Measures

Primary Outcomes (2)

• Maximum tolerated dose(MTD)

  Safety and Tolerability assessed through adverse events to determine maximum tolerated dose

  day 1-28

• Composite CR rate

  CR + CRi +CRMRD-

  Up to 12 months

Secondary Outcomes (4)

• Duration of response

  up to 12 months

• Objective response rate

  up to 12 months

• Event Free Survival

  up to 12 months

• Overall Survival

  up to 12 months

Study Arms (3)

Arm 1

EXPERIMENTAL

Queue 1:Clifutinib Besylate:30mg qd d8-21;Daunorubicin 60 mg/m2 qd d1-3;Cytarabine 100 mg/m2 qd d1-7 Queue 1:Clifutinib Besylate:30mg qd d1-28 ;Azacitidine 75 mg/m2 qd d1-7

Drug: Clifutinib Besylate

Arm 2

EXPERIMENTAL

Queue 1:Clifutinib Besylate:40mg qd d8-21;Daunorubicin 60 mg/m2 qd d1-3;Cytarabine 100 mg/m2 qd d1-7 Queue 1:Clifutinib Besylate:40mg qd d1-28 ;Azacitidine 75 mg/m2 qd d1-7

Drug: Clifutinib Besylate

Arm 3

EXPERIMENTAL

Queue 1:Clifutinib Besylate:60mg qd d8-21;Daunorubicin 60 mg/m2 qd d1-3;Cytarabine 100 mg/m2 qd d1-7 Queue 1:Clifutinib Besylate:60mg qd d1-28 ;Azacitidine 75 mg/m2 qd d1-7

Drug: Clifutinib Besylate

Interventions

Clifutinib Besylate DRUG

The queue 1 is divided into Induction therapy and Consolidation therapy and Maintenance treatment The queue 2 will receive oral Clifutinib Besylate once daily until disease progression or unacceptable toxicity occurs

Also known as: HEC73543

Arm 1; Arm 2; Arm 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cohort 1: 18 years old ≤ age ≤65 years old;Cohort 2: The dose escalation trial only included AML subjects aged ≥60 years; the extended trial included subjects who were ≥60 years old or between 18 and 59 years old (including 18 and 59 years old) and could not tolerate strong chemotherapy.
• It can be primary AML or AML secondary to MDS, and has not been treated; the extension phase requires the subject to be positive for the FLT3-ITD mutation.
• The ECOG score according to the requirements of different groups is as follows: Cohort 1: 0\~1 points; Cohort 2: Age ≥60 years old: 0\~2 points; Age 18\~59 years old (including 18 and 59 years old): 0\~3 points.
• Expected survival time ≥ 12 weeks. 5. Subjects must have adequate organ function. 6.subjects voluntarily participated in the study, and signed a written informed consent form by themselves or their guardians.

You may not qualify if:

• Diagnosed as APL and manifested as t(15;17)(q22;q12) chromosomal translocation, or BCR-ABL positive leukemia；Diagnosed as secondary to AML due to previous chemotherapy or radiotherapy of other tumors; previously received FLT3 inhibitor.
• AML secondary to myeloproliferative tumor (MPN) or acute lymphoblastic leukemia (ALL).
• Subjects who have infiltrated the central nervous system in the past or present.
• Concomitant with other malignant tumors within 5 years before the first medication.
• Thrombosis or embolism occurred within 12 months before the first medication. 6.Pulmonary function tests indicate that subjects have DLCO ≤50% or FEV1 ≤60%, or have difficulty breathing during rest or require continuous oxygen inhalation.
• Subjects with uncontrollable, active infections。 8.Clinically obvious gastrointestinal abnormalities, which may affect the intake, transport or absorption of drugs (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.), or subjects undergoing total gastrectomy。 9.Subjects with a history of psychotropic drug abuse and unable to quit or those with mental disorders。 10.Researchers believe that those who have other severe acute or chronic diseases who are not suitable for participating in clinical trials.

Sponsors & Collaborators

• Sunshine Lake Pharma Co., Ltd.: lead

Study Sites (1)

the First Affiliated Hospital,College of Medicine,Zhejiang University

Hanzhou, Zhejiang, 310003, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Jie Jin, Doctor

  First Affiliated Hospital of Zhejiang University

  STUDY CHAIR

Central Study Contacts

Jie Jin, Doctor

CONTACT

0571-87236685; jiej0503@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Arm 1:30 mg Arm 2:40 mg Arm 3:60 mg

Study Record Dates

• First Submitted: November 12, 2021
• First Posted: November 24, 2021
• Study Start: October 31, 2022
• Primary Completion (Estimated): May 15, 2026
• Study Completion (Estimated): August 15, 2026
• Last Updated: April 13, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)