Status:
NOT_YET_RECRUITING
Treatment Free Remission (TFR) in CML Patients （CML-CP）Study
Lead Sponsor:
Guangdong Provincial People's Hospital
Conditions:
Chronic Myeloid Leukemia
Treatment-free Remission
Eligibility:
All Genders
14+ years
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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;
- Eastern Cooperative Oncology Group physical performance score (ECOG PS) \>=3;
- Other situations deemed unsuitable by the researcher.
Key Trial Info
Start Date :
July 31 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 31 2031
Estimated Enrollment :
203 Patients enrolled
Trial Details
Trial ID
NCT05440747
Start Date
July 31 2022
End Date
October 31 2031
Last Update
July 1 2022
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