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

ConditionsChronic Myeloid Leukemia Treatment-free Remission

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age14+

SponsorGuangdong Provincial People's Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1) Aged >=14 years old male and female;

2) Patients with Ph+ CML-CP should meet any of the following conditions;

Newly diagnosed Patients with CML-CP;

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 ;

Disqualifiers

T315I mutation is known;

Received stem cell transplantation before enrollment;

With other malignant tumors and need active intervention;

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

Trial population

The participants should older than 14 years old, and Newly diagnosed with CML-CP or had been 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

TFR(Treatment-Free Remission)
Other intervention
Withdrawal TKIs(Tyrosine kinase inhibitors: Imatinib or Flumatinib or Nilotinb or Dasatinib)

Treatment groups

203 Participants

are divided into 2 treatment groups

Group A: Newly diagnosed CML-CP patients1 intervention

Group B: Patients with suboptimal response1 intervention

Trial outcomes

Primary outcomes

Deep molecular response(DMR) rate of 12 months

DMR is defined by IS BCR-ABL/ABL achieve MR4.0(≤0.01%)

Time frame

The 12th month

Treatment-Free Remission(TFR) rate of 2 years

The proportion of drug withdrawal

Time frame

The second year

Secondary outcomes

TFR rate

TFR rate of 6/12months，Median duration of TFR

Time frame

The 6months、12months

DMR rate

DMR rate of 24/36/48/60 months, Median duration of DMR, DMR is defined by IS BCR-ABL/ABL achieve MR4.0

Time frame

The 24/36/48/60 months

DMR persistence rate in 2 years

DMR is defined by IS BCR-ABL/ABL achieve MR4.0

Time frame

2 years

Disease progression rate , time to progression

Time and proportion from diagnosis to disease progression to AP or BC

Time frame

The whole study, up to 7 years

Other outcomes

Clonal evolution in CML patients without optimal efficacy

Bone marrow karyotype analysis once a year in the patients without optimal efficacy in milestone through study completion

Time frame

After participants loss optimal efficacy in milestone,and once a years after that, up to 7 years

Resistant mutation rate

Molecular Mutation Examination（qPCR) once a year in patient without optimal efficacy through study completion.

Time frame

The whole study, up to 7 years

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Guangdong Provincial People's Hospital

Lead sponsor

Source ClinicalTrials.gov

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