A Study of the Efficacy and Safety of Flumatinib in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase.

NCT05353205 | Unknown Phase 4

• 1 other identifier: HS-10096-402
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

It's a double-blind , randomized ,multi-center study. The purpose of this study is to explore the efficacy and safety of flumatinib 400mg once daily (QD) versus 600mg QD as the first line therapy in patients with chronic myleiod leukemia(CML) in chronic phase(CP).

Conditions

CML, Chronic Phase

Keywords

CML, Chronic Phase; Flumatinib; BCR-ABL TKI; Dose-optimization; Double-blind; Phase 4

Outcome Measures

Primary Outcomes (1)

• Early molecular response(EMR) rate at 3 months

  Molecular response is assessed using BCR-ABL transcript levels and measured by realtime quantitative polymerase chain reaction(RQ-PCR). Early molecular response is defined as a ratio BCR-ABL/ABL ≤10% on the international scale (IS).

  3 months

Secondary Outcomes (14)

• Major molecular response(MMR) rate at month 3,6,9 and 12

  3, 6, 9 and 12 months

• MR4.0 rate at month 3,6,9 and 12

  3, 6, 9 and 12 months

• MR4.5 rate at month 3,6,9 and 12

  3, 6, 9 and 12 months

• Complete cytogenetic response（CCyR）rate at month 3,6,9 and 12

  3, 6, 9 and 12 months

• Complete hematologic response(CHR) rate at month 1,2,3,4,5,6,9 and 12

  1,2,3,4,5,6,9 and 12 months

Study Arms (2)

Flumatinib (400mg)

EXPERIMENTAL

Flumatinib 400mg QD

Drug: Flumatinib mesylate tablets (400mg)

Flumatinib (600mg)

EXPERIMENTAL

Flumatinib 600mg QD

Drug: Flumatinib mesylate tablets (600mg)

Interventions

Flumatinib mesylate tablets (400mg) DRUG

Flumatinib 400mg +Placebo for flumatinib are administered orally daily. Patients are randomized to flumatinib 400mg QD.

Flumatinib (400mg)

Flumatinib mesylate tablets (600mg) DRUG

Flumatinib 600mg is administered orally daily. Patients are randomized to flumatinib 600mg QD.

Flumatinib (600mg)

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent form.
• Men or women aged more than or equal to (≥) 18 years, and less than (\<) 75 years.
• ECOG performance status of 0-2.
• Patients with philadelphia chromosome positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP) within 6 months of diagnosis.
• Adequate organ function.
• Men or women should be using adequate contraceptive measures throughout the study; Females should not be breastfeeding at the time of screening, during the study and until 6 months after completion of the study.
• Females must have evidence of non-childbearing potential.

You may not qualify if:

• Known atypical CML or presence of additional chromosomal abnormalities.
• Known presence of the T315I mutation.
• Treatment with tyrosine kinase inhibitor(s) prior to randomization.
• Any treatment with anti-CML activity for longer than 2 weeks(exception of hydroxyurea or anagrelide) or hematopoietic stem cell transplantation prior to randomization .
• Prior treatment with splenectomy.
• Impaired cardiac function including any one of the following:
• Resting corrected QT interval (QTc) \> 470 ms obtained from electrocardiogram (ECG), using the screening clinic's ECG machine and Fridericia's formula for QT interval correction (QTcF).
• Any clinically important abnormalities in rhythm, conduction, or morphology of the resting ECG.
• Any factors that increase the risk of QTc prolongation or risk of arrhythmic events,
• Left ventricular ejection fraction (LVEF) ≤ 50%.
• During screening period, ECG examination showed average heart rate \<50 beats per minute.
• Myocardial infarction occurred within 12 months of randomization;
• Congestive heart failure occurred within 6 months of randomization;
• Uncontrollable angina.
• Stroke or transient ischemic attack within 6 months of randomization.

Sponsors & Collaborators

• Jiangsu Hansoh Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Institute of Hematology and Oncology, Harbin The First Hospital

Harbin, Hei Longjiang, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Chronic-Phase

Condition Hierarchy (Ancestors)

Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jun Ma

  Institute of Hematology and Oncology, Harbin The First Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Ma

CONTACT

13304518000; majun0322@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2022
• First Posted: April 29, 2022
• Study Start: November 23, 2021
• Primary Completion: December 30, 2022
• Study Completion: September 30, 2025
• Last Updated: April 29, 2022

Record last verified: 2022-04

Locations

CN (1)