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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)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200058479
Enrollment
Unknown
Registered
2022-04-09
Start date
2022-05-01
Completion date
Unknown
Last updated
2024-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic myeloid leukemia

Interventions

None listed

Sponsors

Guangdong Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
14 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age >= 14 years, male or female; 2. For Ph+CML-CP patients, one of the following conditions should be met: (1) Newly diagnosed patients with CML-CP; (2) CML-CP patients who did not respond optimally to TKIs (BCR-ABLIS > 10% at 3 months or BCR-ABLIS > 1% at 6 months or BCR-ABLIS > 0.1% at 12 months and BCR-ablis > 0.01% at 24 months) or were intolerant to some TKI. Definition of diagnosis: Bone marrow cytogenetics Ph chromosome t(9;22) Positive, BCR-ABL fusion gene was detected by FISH, or BCR-ABL fusion gene was detected by Q-PCR ( > 10%); 3. No history of hematopoietic stem cell transplantation; 4. The pregnancy test of fertile female patients was negative (within 7 days before enrollment); 5. There is a need for drug withdrawal, and informed consent must be signed voluntarily before screening.

Exclusion criteria

Exclusion criteria: 1. T315I mutation is known to exist; 2. Received stem cell transplantation before joining the group; 3. Suffering from other malignant tumors and requiring active intervention; 4. Those who are unable to comply with the program steps or follow up on time; 5. The physical fitness score (EcoGPS) of the Eastern Cancer Collaborative Group is >= 3; 6. Other situations that the researcher thinks are not suitable for selection.

Design outcomes

Primary

MeasureTime frame
treatment free remission rate of 2 years;deep molecular response of 12 months;

Countries

China

Contacts

Public ContactJianyu Weng

Guangdong Provincial People's Hospital

wengjianyu1969@163.com+86 13924197172

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026