Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05367765
Other study ID # HS-10096-401
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
Start date April 30, 2022
Est. completion date April 30, 2028

Study information

Verified date April 2022
Source Jiangsu Hansoh Pharmaceutical Co., Ltd.
Contact Jun Ma
Phone 13304518000
Email majun0322@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Flumatinib is an orally available TKI with high selectivity and potency against BCR-ABL1 kinase. It's a multi-center, open-label, real world study to explore the efficacy and safety of Flumatinib versus Imatinib as the first line therapy in patients with chronic myleiod leukemia(CML) in chronic phase(CP).


Description:

The purpose of this study is to investigate the long-term efficacy and safety of Flumatinib versus Imatinib in newly diagnosed CML-CP patients to the provide the real world evidence for the clinical treatment of CML-CP in China. The overall design is a multicenter, prospective, observational study. The study plans to enroll 2,400 newly diagnosed CML-CP subjects.The primary efficacy endpoint is the rate of major molecular response (MMR) , as measured by RQ-PCR at 12 months. Hematologic response, molecular response and cytogenetic response will be assessed at baseline and a certain frequency after treatment, until study completion. (A month is defined as 28 days)


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 2400
Est. completion date April 30, 2028
Est. primary completion date April 30, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Men or women aged more than or equal to (=) 18 years. 2. Patients with Philadelphia chromosome positive chronic myelogenous leukemia in chronic phase (Ph+ CML-CP) within 6 months of diagnosis.. 3. Eastern Cooperative Oncology Group (ECOG) performance status: 0~2. 4. Signed and dated Informed Consent Form. Exclusion Criteria: 1. Patients with previously documented T315I mutation. 2. Received BCR-ABL TKI(s) treatment before enrollment. 3. Any treatment with anti-CML therapy over 2 weeks or hematopoietic stem cell transplantation before enrollment 4. Participated in other clinical trials that might affect the efficacy and safety of CML during this study. 5. Pregnant or lactating female.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Flumatinib
Flumatinib 600mg orally daily
Imatinib
Imatinib 400mg orally daily (Reference drug instructions)

Locations

Country Name City State
China Institute of Hematology and Oncology, Harbin The First Hospital Harbin Heilongjiang

Sponsors (1)

Lead Sponsor Collaborator
Jiangsu Hansoh Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Major molecular response (MMR) rate at 12 months MMR is defined as a ratio BCR-ABL/ABL =0.1% on the international scale as measured by RQ-PCR 12 months
Secondary MMR rate of high-risk population treated at the end of 12 months High-risk population:Sokal score>1.2
MMR is defined as a ratio BCR-ABL/ABL =0.1% on the international scale as measured by RQ-PCR.
12 months
Secondary MMR rate at 6, 24 and 36 Months MMR is defined as a ratio BCR-ABL/ABL =0.1% on the international scale as measured by RQ-PCR. 6, 24 and 36 Months
Secondary Complete Cytogenetic Response(CCyR) rate at 6, 12, 24 and 36 Months Cytogenetic response (CyR) is based on the prevalence of Ph+ cells in metaphase from bone marrow (BM) sample. CCyR is defined as 0% Ph+ metaphases in the bone marrow. 6, 12, 24 and 36 Months
Secondary Percentage of participants with transformation-free survival (TFS) TFS was defined as the time between the first dose and the date of transition to AP/BP or the last efficacy assessment during treatment. up to 60 Months
Secondary Percentage of participants with progression free survival (PFS) PFS is defined as the time from the first dose to the date of earliest transition to AP/BC, or the date of death from any cause. up to 60 Months
Secondary Percentage of participants with overall survival (OS) OS was defined as the time between the first dose and the date of death from any cause. up to 60 Months
Secondary Incidence and severity of adverse events (AE) Assessed by number and severity of adverse events as recorded on the case report form, vital signs, laboratory variables, physical examination, electrocardiogram, and NCI CTCAE v5.0. From baseline until 28 days after the last dose
See also
  Status Clinical Trial Phase
Not yet recruiting NCT06409936 - PEARL Study: PotEntial of Asciminib in the eaRly Treatment of CML Phase 2
Recruiting NCT05353205 - A Study of the Efficacy and Safety of Flumatinib in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase. Phase 4
Not yet recruiting NCT06121765 - Metabolic Alternation and Clinicohematological Characteristic in Chronic Phase CML in Patient Treated With TKI
Not yet recruiting NCT06423911 - A Phase 3 Registrational Study of Olverembatinib (HQP1351) in Patients With CML Phase 3
Recruiting NCT03459534 - A Phase 3 Study for the Efficacy and Safety of Radotinib in CP-CML Patients With Failure or Intolerance to Previous TKIs Phase 3
Completed NCT03885830 - Precision Dosing of Tyrosine Kinase Inhibitors in CML Patients
Completed NCT04883125 - Value of Using Pioglitazone in Chronic Myeloid Leukemia Treatment Phase 2
Recruiting NCT02949570 - Study to Assess Efficacy and Safety of Inecalcitol in Imatinib-Treated Residual Chronic Myeloid Leukaemia: INIM Study Phase 2
Recruiting NCT05367700 - A Study of HS-10382 in Patients With Chronic Myeloid Leukemia. Phase 1