Chronic-phase chronic myeloid leukemia
Conditions
Interventions
The PEG-IFNa-2b combined with TKI group(Cohort 1 ):None
TKI group(Cohort 1):None
The PEG-IFNa-2b combined with TKI group(Cohort 2 ):None
Sponsors
The Second Medical Center of Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: Cohort 1: Inclusion criteria (all inclusion criteria must be met to be eligible for inclusion) 1. Age >= 18 years and = 18 years and <= 90 years, with no gender restrictions; 2. Confirmed as chronic-phase chronic myeloid leukemia patients with Philadelphia chromosome positive (Ph+) (refer to the "Chronic Myeloid Leukemia Diagnosis and Treatment Guidelines (2022 Edition)"); 3. Confirmed as having the common BCR-ABL transcript type (M-BCR-ABL); 4. Chronic-phase CML patients who have not achieved an ideal remission state with TKI treatment: (1) Failure to achieve early molecular response (EMR, BCR::ABL1 IS <=10%) within 3 months; (2) Failure to achieve complete cytogenetic response (CCyR, BCR::ABL1 IS <=1%) within 6 months; (3) Failure to achieve major molecular response (MMR, BCR::ABL1 IS <=0.1%/MR 3.0) within 12 months; (4) Failure to achieve deep molecular response (BCR::ABL1 IS <=0.01%/MR 4.0) at any time; 5. Voluntary signing of informed consent.
Exclusion criteria
Exclusion criteria: Exclusion criteria (meeting any one of the exclusion criteria will result in exclusion) 1. Philadelphia chromosome negative (Ph-), except for M-BCR-ABL transcript types; 2. Allergic to TKI drugs, interferon and their drug components; 3. Pregnant women, women planning pregnancy and lactating women, and men with plans for fatherhood; 4. Neutrophil count 1.5 times the upper limit of normal (ULN), total bilirubin >= 2ULN, ALT > 2.5ULN, AST > 2.5ULN; 6. Patients who have previously received hematopoietic stem cell transplantation or cellular immunotherapy; 7. Individuals and their close blood relatives (parents, siblings, etc.) with a history of severe mental illness, especially depression. Severe mental illness is defined as major depressive disorder or psychosis, suicide attempts, hospitalization due to mental illness, or a period of incapacity due to mental illness; 8. History of immune-mediated diseases (such as inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, rheumatoid arthritis) or abnormally elevated levels of autoantibodies; 9. History of severe epilepsy or currently receiving antiepileptic drug treatment; 10. Unstable diabetes, hypertension, thyroid disease, etc.; 11. History of severe retinopathy or other evidence indicating retinopathy; 12. Patients with severe diseases of important organs such as heart, lungs, kidneys, and brain; 13. Patients with other malignant tumors; 14. Active hepatitis A, C, D, E, or HIV infection; 15. Any history of organ transplantation and existing functional grafts (except for corneal or hair transplantation); 16. Patients deemed unsuitable for participation in this clinical trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients achieving a deep molecular response (DMR) after 48 weeks of treatment(Cohort 1);The proportion of patients who can reach the optimal target for the next stage of treatment after 48 weeks of treatment with PEG-IFNa-2b combined with TKI(Cohort 2); | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of patients who achieved the primary molecular response (MMR) after 48 weeks of treatment(Cohort 1);The proportion of patients achieving MMR and DMR after 24 weeks of treatment(Cohort 1);The complete hematological response (CHR) rates at the 12th, 24th, 36th and 48th weeks of treatment(Cohort 1);The complete cytogenetic response (CCyR) rates at the 12th, 24th, 36th and 48th weeks of treatment;The changes in BCR-ABL gene load compared to the baseline at weeks 12, 24, 36, and 48 of treatment(Cohort 1);The safety assessment includes adverse events, vital signs, laboratory test results, and changes in imaging examinations(Cohort 2).; | — |
Countries
China
Contacts
Public ContactLu Xuechun
The Second Medical Center of Chinese PLA General Hospital
Outcome results
None listed