Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:09 PM
Ignite Modification Date:
2025-12-24 @ 11:09 PM
NCT ID:
NCT05379569
Eligibility Criteria:
Inclusion Criteria:
1. Ages 18-55.
2. The patient was diagnosed as acute B-lymphoblastic leukemia, which was confirmed by bone marrow cell morphology, cytochemistry, immunotyping and chromosome examination, including acute chronic myelocytic leukemia, Ph-acute B-lymphoblastic leukemia, and acute B-lymphoblastic leukemia after CART treatment.
3. The diagnostic criteria for b-blastic leukemia in remission were: complete hematologic response (CR) with negative minimal residual lesions (MRD) after regular induction of remission chemotherapy, or complete hematologic response with negative MRD after CART treatment.
4. ECOG physical fitness status score ≤2.
5. All organs function normally and meet the following inspection standards:
A) Liver function ALT, AST and TBIL≤2 times the upper limit of normal value B) BUN and Cr of renal function ≤1.25 times the upper limit of normal value.
6. Have the following cardiac function conditions: ecg examination did not indicate any acute myocardial infarction, arrhythmia or atrioventricular block of degree I or above; Centerless incomplete function; No active rheumatic heart disease; There was no indication of cardiac enlargement on chest radiograph or physical examination.
(7) The patient had a qualified allogeneic hematopoietic stem cell transplantation donor, including haploid, myeloma and sibling.
8\) The patient and its legal client have the desire and requirement for hematopoietic stem cell transplantation, and sign the informed consent, and are willing to and abide by the treatment plan, follow-up plan, laboratory examination, etc.
9\) The donor meets the donation requirements-
Exclusion Criteria:
1. There are any contraindications for allogeneic hematopoietic stem cell transplantation.
2. Ph+ acute lymphoblastic leukemia
3. Serious damage of important organ functions, such as respiratory failure, heart failure, decompensated liver insufficiency, renal insufficiency, etc.
4. Pregnant or lactating women.
5. Those who are undergoing clinical trials of other drugs.
6. Patients suffering from other serious acute or chronic physical or mental diseases, or abnormal laboratory examination, which may affect the administration of study drugs and the researchers' judgment of the condition and interpretation of the test results, are not suitable to participate in the clinical trial.
7. The donor does not fit the conditions of the donor.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT05379569
Study Brief:
Protocol Section:
NCT05379569