NCT05440747Not yet recruiting
Treatment Free Remission (TFR) in CML Patients （CML-CP）Study
A Multicenter, Observational Register Study of Treatment Free Remission in Patients With Chronic Myeloid Leukemia (CML-CP)
Source: ClinicalTrials.gov · Last updated 1 Jul 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 203 (estimated)
- First submitted
- 2 Apr 2022
- Start date
- 31 Jul 2022
- Primary completion date
- 31 Oct 2024
- Lead sponsor
- Guangdong Provincial People's Hospital
- NCT number
- NCT05440747
What you commit to
- Study type: Observational
- Planned participants: 203
- From 31 Jul 2022 to the primary completion date, 31 Oct 2024
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Received stem cell transplantation before enrollment;
Other illness
- With other malignant tumors and need active intervention;
Other
- T315I mutation is known;
- Those who are unable to follow the protocol steps or follow up on time;
- Eastern Cooperative Oncology Group physical performance score (ECOG PS) \>=3;
- Other situations deemed unsuitable by the researcher.
Who the study is looking for
- 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 ;
- 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.
Age in the registry: 14 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.