Clinical trial · Interventional
Safety and Efficacy of Donor T-lymphocytes Depleted ex Vivo of Host Alloreactive T-cells (ATIR) in Patients With a Hematologic Malignancy Who Received a Hematopoietic Stem Cell Transplantation From a Haploidentical Donor
An Exploratory, Open-label, Multicenter Study to Evaluate the Safety and Efficacy of ATIR, Donor T-lymphocytes Depleted ex Vivo of Host Alloreactive T-cells, in Patients With a Hematologic Malignancy, Who Received a CD34-selected Hematopoietic Stem Cell Transplantation From a Haploidentical Donor
NCT01794299CI-TRIAL-00051208completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine whether ATIR is safe and effective in reducing transplant-related mortality and improving overall survival, when infused in patients with a hematologic malignancy following a T-cell depleted stem cell graft from a related haploidentical donor.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Myelodysplastic Syndrome | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ATIR | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ATIR
- interventionNames
- Biological: ATIR
Primary outcomes (1)
- measure
- Transplant-related Mortality (TRM)
- timeFrame
- At 6 months post HSCT
- description
- TRM is defined as death due to causes other than disease relapse or progression, or other causes which are unrelated to the transplantation procedure (e.g. accident, suicide). The TRM rate is displayed as a function of time using the Kaplan-Meier method. The TRM rate at 6 months post HSCT is estimated from this analysis.
Secondary outcomes (6)
- measure
- Immune Reconstitution
- timeFrame
- Up to 24 months post HSCT
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Any of the following hematologic malignancies: a) Acute myeloid leukemia (AML) in first remission with high-risk features or in second or higher remission b) Acute lymphoblastic leukemia (ALL) in first remission with high-risk features or in second or higher remission c) Myelodysplastic syndrome (MDS): transfusion-dependent, or intermediate or higher Revised International Prognostic Scoring System (IPSS-R) risk group * Eligible for haploidentical stem cell transplantation according to the investigator Exclusion Criteria: * Availability of a suitable matched related or unrelated donor following a donor search * In second or higher remission with the previous remission having lasted less than 6 months * Diffusing capacity for carbon monoxide (DLCO) \< 50% predicted * Left ventricular ejection fraction \< 50% (evaluated by echocardiogram or multiple gated acquisition \[MUGA\]) * Aspartate aminotransferase (AST) \> 2.5 x upper limit of normal (ULN)(CTCAE grade 2) * Bilirubin \> 1.5 x ULN (CTCAE grade 2) * Creatinine clearance \< 50 mL/min (calculated or measured) * Positive test for human immunodeficiency virus (HIV) * Positive pregnancy test (women of childbearing age only) * Prior allogeneic stem cell transplantation using stem cells from a matched sibling donor, a matched unrelated donor, a haploidentical donor, or a cord blood donor * Prior autologous stem cell transplantation * Stay at intensive care unit for more than 2 months in the preceding 12 months * Estimated probability of surviving less than 3 months * Known allergy to any of the components of ATIR (e.g., dimethyl sulfoxide) * Any other condition which, in the opinion of the investigator, makes the patient ineligible for the study Donor inclusion criteria * Haploidentical family donor with 2 to 3 mismatches at the human leukocyte antigen (HLA)-A, -B and/or -DR loci of the unshared haplotype * Male or female, age ≥ 16 and ≤ 75 years * Eligible for donation according to the transplantation center Donor exclusion criteria * Positive viral test for HIV-1, HIV-2, hepatitis B virus (HBV), hepatitis C virus (HCV), Treponema pallidum, human T-lymphotropic virus (HTLV)-1\*, HTLV-2\*, or West Nile virus (WNV)\* (if tested) (\* at Canadian centers only) * Positive pregnancy test or nursing (women of childbearing age only)
References
Publications (0)
Data not yet available
No reference posted for this study.