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 @ 1:17 PM
Ignite Modification Date:
2025-12-26 @ 1:17 PM
NCT ID:
NCT02014506
Eligibility Criteria:
Inclusion Criteria:
A. Disease inclusions
1. Hematologic malignancy:
* Acute lymphoblastic leukemia including induction failure, CR1 (Ph+, t(4:11), hypodiploid and other very high risk features), ≥ CR2, infant ALL with MLL or other unfavorable features
* Acute myeloid leukemia excluding CR1 with t(8:21), inv(16), t(15:17), and Down syndrome
* Myelodysplastic syndrome: RCC with -7 or RCC in need of transfusion
* Chronic myeloid leukemia in AP
* Juvenile myelomonocytic leukemia
* Malignant lymphoma, NHL or HD, after failed autologous HSCT
* Other
2. Non-hematologic malignancy
* Relapsed or refractory solid tumors including neuroblastoma, rhabdomyosarcoma and so on
3. Non-malignant hematologic disease
* Acquired severe and very severe aplastic anemia
* Fanconi anemia
* Paroxysmal nocturnal hemoglobinuria
* Congenital dyserythropoietic anemia
* Others
4. Inherited or metabolic disease
* Hemophagocytic lymphohistiocytosis
* Malignant osteopetrosis
* Storage diseases
* Others B. Recipient inclusions
1\. Age \< 21 years 2. No HLA-identical stem cell donor available 3. Lansky-Play performance score \>60 4. No active infection at the time of transplantation
Exclusion Criteria:
1. HIV-infection
2. Presence of active and serious infection
3. Cardiac ejection fraction \<35% on echocardiography
4. Severe pulmonary dysfunction (DLCO \<30%)
5. Liver function abnormalities with bilirubin \>4mg/dL and elevation of transaminases \> 400U/L
6. Concurrent severe or uncontrolled medical disease
7. Patients who are pregnant
8. Patients unwilling or unable to comply with the protocol or unable to give informed consent
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
21 Years
Study:
NCT02014506
Study Brief:
Protocol Section:
NCT02014506