Treatment Free Remission (TFR) in CML Patients （CML-CP）Study

NCT ID: NCT05440747

Last Updated: 2022-07-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 203 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-07-31
• Study Completion Date: 2031-10-31

Brief Summary

Improving the quality of life and achieving Treatment-Free Remission(TFR) is a long-term goal of treatment in CML-CP patients, and deep molecular response (DMR) is necessary to achieve TFR. Cording to the historical literature, it is reported that patients with CML-CP take MMR as the therapeutic target, and the acquisition rate of DMR under long-term TKI treatment is 50%. The 2-year success rate of TFR patients was 50%. Therefore, maybe only 25% of patients with CML can successfully stop the drug for a long time. It cannot meet the withdrawal needs of patients with long-term drug survival.

This study is to design a real-world observational registration study for optimal effect. On the premise of taking DMR as the target decision, through initial treatment intervention, improve the DMR rate, which will promote clinical practice, so as to improve the 2-year TFR rate of cml-cp patients. This study is a multicenter, observational, prospective registry to identify the optimal treatment for achieving TFR in CML patients. In this study, the investigators will assess the deep molecular response after 12 months of treatment and the 2-year treatment-free remission rate (TFR 2y) after drug discontinuation.

Eligible participants with CML-CP can be enrolled. The observation period of all participants is at least 60 months, of which the first 36 months is the shortest treatment period, and the last 24 months is the TFR observation period after TKIs (Imatinib/Flumatinib/Nilotinb/ Dasatinib) withdrawal. During the treatment phase, participants can receive TKIs ± IFN (or other treatments) as first-line/second-line treatment, and the treatment plan will be adjusted according to the molecular response. Patients should accept TKI treatment for at least 3 years or more, and MR4/MR4.5 should achieve at least 2 years before discontinuation.

Conditions

Chronic Myeloid Leukemia; Treatment-free Remission

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Newly diagnosed CML-CP patients

Treat with TKI (Imatinib or Flumatinib or Nilotinb or Dasatinib).

TFR(Treatment-Free Remission)

Intervention Type: OTHER

Withdrawal TKIs(Tyrosine kinase inhibitors: Imatinib or Flumatinib or Nilotinb or Dasatinib)

Patients with suboptimal response

1. Treat with original TKI

2. Treat with original TKI combined with interferon/thymosin;

3. Replace other TKI ;

4. Replace other TKI and combined with interferon/thymosin.

TFR(Treatment-Free Remission)

Intervention Type: OTHER

Withdrawal TKIs(Tyrosine kinase inhibitors: Imatinib or Flumatinib or Nilotinb or Dasatinib)

Interventions

TFR(Treatment-Free Remission)

Withdrawal TKIs(Tyrosine kinase inhibitors: Imatinib or Flumatinib or Nilotinb or Dasatinib)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 1) Aged >=14 years old male and female;
• 2) Patients with Ph+ CML-CP should meet any of the following conditions;

1. Newly diagnosed Patients with CML-CP;

2. The CML-CP patients who treated with TKI (Imatinib, Nilotinib, Dasatinib and Flumatinib) are not achieved optimal （BCR-ABLIS>10% in 3 months, BCR-ABLIS>1% in 6 months, BCR-ABLIS>0.1% in 12 months or BCR-ABLIS>0.01% in 24 months ）or intolerance to these TKIs; The definition of the confirmed diagnosis: Bone marrow cytogenetics Ph chromosome t(9;22) positive and/or BCR-ABL fusion gene positive by FISH, and/or BCR-ABL fusion gene positive(>10%) by Q-PCR ;

• 3) Never received stem cell transplantation before enrollment;
• 4) Female patients with fertility have a negative pregnancy test (within 7 days before enrollment).

All Patients with TFR requeirement should provid written informed consent before enrollment.

Exclusion Criteria

1. T315I mutation is known;

2. Received stem cell transplantation before enrollment;

3. With other malignant tumors and need active intervention;

4. Those who are unable to follow the protocol steps or follow up on time;

5. Eastern Cooperative Oncology Group physical performance score (ECOG PS) >=3;

6. Other situations deemed unsuitable by the researcher.

• Minimum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangdong Provincial People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

WENG Jian yu

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jianyu Jianyu, PhD

Role: STUDY_CHAIR

Sponsor GmbH

Central Contacts

Jianyu Weng, PhD

Role: CONTACT

gdph_wjy21@gd.gov.cn

+86-020-83827812

Lisi Huang

Role: CONTACT

lisi_huang5413@163.com

+86-020-83827812

Other Identifiers

GDPH-CML-TFR-2020-12

Identifier Type: -

Identifier Source: org_study_id