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:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2025-12-25 @ 2:41 AM
NCT ID:
NCT03091933
Eligibility Criteria:
Inclusion Criteria:
* Prior allogeneic HLA-matched stem cell transplantation
* Any of the following hematologic malignancies:
* Acute myeloid leukemia (AML)
* Acute lymphoblastic leukemia (ALL)
* Biphenotypic leukemia
* Chronic lymphoblastic leukemia (CLL)
* Hodgkin Lymphoma
* Non-Hodgkin Lymphoma (NHL)
* Multiple Myeloma (MM)
* Myelodysplastic syndrome (MDS)
* Presence of HLA2:01 and / or HLA44:02 and / or HLA-B\*44:03, HLA-A\*01:01; HLA-A\*03:01; HLA-A\*11:01;HLA A\*24:02; HLA-A\*29:02; HLA-A\*32:01; HLA-B\*07:02; HLA-B\*08:01; HLA B\*13:02; HLA-B\*14:02; HLA-B\*15:01; HLA-B\*18:01; HLA-B\*27:05; HLA B\*35:01; HLA-B\*40:01; or HLA-B\*57:01
* At least 6 months after allogeneic hematopoietic stem cell transplantation
* Presence of detectable malignant disease post-transplantation in the form of molecular, cytogenetic or hematologic relapse of the malignant disorder.
* Eligible to receive cytoreductive chemotherapy
* Original stem cell donor available for leukocyte donation.
* ECOG performance status ≤2.
* Ability to provide written consent.
* Accessible for treatment and follow up.
* Presence of a targetable MiHA based on exome sequencing of the patient and donor
Exclusion Criteria:
* Active acute GVHD \> grade I
* Prior grade III-IV acute GVHD within the last year
* Uncontrolled chronic GVHD
* Prior administration of donor lymphocyte infusion (DLI)
* Use of T-cell depleting antibodies in the previous 30 days
* Treatment with immune suppressors (oral or parenteral steroids corresponding to a dose of prednisone greater than 7.5 mg/day, calcineurine inhibitors, rapamycin, mycophenolate mofetil, etc) during the last 30 days.
* Uncontrolled active infection
* Uncontrolled central nervous system involvement by leukemia cells (blasts).
* AST or ALT \> 2.5 x ULN (CTCAE grade 2)
* Bilirubin \> 1.5 x ULN (CTCAE grade 2)
* Creatinine clearance \< 50 mL/min
* Positive test for human immunodeficiency virus (HIV)
* Positive pregnancy test (women of childbearing age only)
* Lactating women: the safety of this therapy on breast milk is not known.
* Estimated probability of surviving less than 3 months
* Known allergy to any of the components of GLIDE (e.g., dimethyl sulfoxide)
* Intercurrent illness or medical condition precluding safe administration of the planned protocol treatment or required follow-up.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03091933
Study Brief:
Protocol Section:
NCT03091933