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:
2025-12-26 @ 11:09 AM
Ignite Modification Date:
2025-12-26 @ 11:09 AM
NCT ID:
NCT00984412
Eligibility Criteria:
Inclusion Criteria:
1. Patient age 3-50 years old with refractory acute leukemia (primary refractory or refractory relapse I or II) unresponsive to up to 2 salvage lines with a matched donor (related or unrelated, matched defined as 8/8 HLA matching).
2. A donor willing and capable of donating peripheral blood stem cells and preferably also bone marrow cells, and lymphocytes if indicated.
3. Each patient / patient's guardian must sign written informed consent.
4. Patients must have an ECOG PS ≤ 1; Creatinine \<1.5 mg/dl; Ejection fraction \>45%; DLCO \>70% of predicted; Serum bilirubin \<2 mg/dl; elevated GPT or GOT \< 2 x normal values before transplant I.
Exclusion Criteria:
1. Not fulfilling any of the inclusion criteria.
2. In complete or very good partial remission.
3. Beyond 2nd relapse.
4. Received \> 2 lines of salvage therapy.
5. Active CNS involvement of the leukemia
6. Active life-threatening infection.
7. Overt untreated infection.
8. HIV seropositivity, Hepatitis B or C antigen positivity with evidence of active hepatitis.
9. Donor contraindication (HIV seropositive confirmed by Western Blot, Hepatitis B antigenemia, HCV, evidence of bone marrow disease, unable to donate bone marrow or peripheral blood due to concurrent medical condition).
10. Previous autologous or allogeneic stem cell transplantation.
11. Inability to comply with study requirements.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
50 Years
Study:
NCT00984412
Study Brief:
Protocol Section:
NCT00984412