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 @ 7:17 PM
Ignite Modification Date:
2025-12-24 @ 7:17 PM
NCT ID:
NCT01494103
Eligibility Criteria:
Inclusion Criteria:
Inclusion Criteria at Time of Procurement:
1. Lack of a suitable conventional donor (i.e. 5/6 or 6/6 related, or 5/6 or 6/6 unrelated donor), or presence of a rapidly progressive disease not permitting time to identify an unrelated donor.
2. High risk disease in one of the following:
* Myelodysplastic syndrome (MDS) in one of the following categories: RCMD with an IPSS-R of intermediate, poor, or very poor, RAEB-1, or RAEB-2
* Acute myeloid leukemia (AML) after first relapse or primary refractory disease
* Chronic myelogenous leukemia (CML) in Chronic Phase 2 or greater, Accelerated Phase or Blast Crisis
* Acute lymphoblastic leukemia (ALL) after first relapse or primary refractory disease, or High-Grade Non Hodgkin lymphoma (NHL) Stage III or IV after first relapse or primary refractory disease
* Hemophagocytic lymphohistiocytosis (HLH)
* Familial hemophagocytic lymphohistiocytosis (FLH)
* Viral-associated hemophagocytic syndrome (VAHS)
* T or NK cell lymphoproliferative syndrome
* X-linked lymphoproliferative disease (XLP)
Inclusion Criteria at Time of T Cell Infusion:
1. Engrafted with an absolute neutrophil count (ANC) \> 500 cells/µL
2. Greater than or equal to 50% donor chimerism in either peripheral blood or bone marrow, or relapse of their original disease
3. Life expectancy \> 30 days
4. Lansky/Karnofsky score greater than or equal to 60
5. Absence of severe renal disease (creatinine \> 2X upper limit of normal for age)
6. Absence of severe hepatic disease (direct bilirubin \> 3X upper limit of normal or SGOT \> 3X upper limit of normal)
7. Oxygen saturation \> 94% on room air
8. Patient/Guardian able to give informed consent
9. AP1903 available in sufficient quantities to allow for treatment of the patient
Exclusion Criteria:
Exclusion Criteria at Time of T Cell Infusion:
1. GvHD
2. Severe intercurrent infection
3. Pregnancy\*
4. Other investigational drugs in the prior 30 days
* Pregnancy test only required for at-risk individuals, defined as female patients of childbearing potential who have received a reduced-intensity conditioning regimen.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT01494103
Study Brief:
Protocol Section:
NCT01494103