Clinical trial · Interventional
Evaluation of a Donor Testing Kit for the Prediction of AGVHD in Patient Receiving a Peripheral Blood Stem Cell Allograft
Evaluation of a Donor Testing Kit for the Prediction of Acute GVHD in Patient Receiving a Peripheral Blood Stem Cells Allograft- Predictor 2
NCT03887156CI-TRIAL-00054113Predictor2unknownPhase 2 / Phase 3ClinicalTrials.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 aim is to validate an in vitro diagnosis medical device to predict grade II to IV aGVHD after a cell graft
Conditions
Conditions (6)
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 Leukemia Biphenotypic in Remission | Acute Biphenotypic Leukemia | CURATED_BROADER | 0.78 |
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Acute Myeloid Leukemia in Remission | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Lymphoma in Remission | Lymphoma | CURATED_BROADER | 0.78 |
| Myelodysplasia With Stable Blasts is Cell Number and < 10% of Blastocysts | — | UNRESOLVED | — |
| Non-progressive Myeloproliferative Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ex vivo capacities of CD4neg INkT expansion of the peripheral blood donor with the Predictor test | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Arm 1
- description
- One arm
- interventionNames
- Diagnostic Test: Ex vivo capacities of CD4neg INkT expansion of the peripheral blood donor with the Predictor test
Primary outcomes (1)
- measure
- Number of aGVHD of grade II to IV observed for the recipients
- timeFrame
- 3 month after allograft performance
- description
- To predict the risk of acute GVHD. Number of aGVHD of grade II to IV observed for the recipients in the 3 months after the graft and results of the Predictor test, before graft, on their own donor's blood.
Secondary outcomes (4)
- measure
- Evaluation of medico-economic aspect of the Predictor test Total estimated cost of the aGVHD treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * PATIENT : * Age between 18 and 65 years ( included ) * Being candidate to a graft of peripheral hematopoietic stem cells , according the following criteria : * HLA compatibility 10 / 10 with the selected donor * Malignant haematological disorder as described below : * Acute Myeloid Leukemia (AML) or Acute Lymphoblastic Leukemia ( ALL) in 1st or 2d complete remission * Aggressive lymphoma in complete remission * Non - progressive myeloproliferative syndrome , * Myelodysplasia with stable blasts is cell number and \< 10 % of blastocysts, * Acute leukemia biphenotypic in 1st or 2d complete remission * Sequential graft conditioning, myeloablative or with a reduced intensity, both may include ATG * Classical scheme for immunosuppression decrease ( from day 90 to day 180 ) • Not being opposed to medical data collection DONOR * Adult ( ≥ 18 year old) up to the maximum authorized by each National Transplantation Authority * Being a patient's sibling or registered in the Bone Marrow Donors Worldwide registry or a national registry * Being candidate to a Peripheral Blood Stem Cells donation with a Human Leucocyt Antigen (HLA) 10 / 10 compatibility with the recipient , * Signed and dated informed consent ( in accordance with local regulation of the country in which the observation is performed ) Exclusion Criteria: * Participating in a clinical trial, if interventional on the prophylaxis treatment ( not on the prophylaxis ) of GVHD, in the 30 days prior to the inclusion and during the Predictor 2 study , * Being placed under legal supervision , * Presenting any impossibility to fulfil the study requirements, due to geographical, social or physical reasons
References
Publications (1)
- BACKGROUNDRubio MT, Bouillie M, Bouazza N, Coman T, Trebeden-Negre H, Gomez A, Suarez F, Sibon D, Brignier A, Paubelle E, Nguyen-Khoc S, Cavazzana M, Lantz O, Mohty M, Urien S, Hermine O. Pre-transplant donor CD4- invariant NKT cell expansion capacity predicts the occurrence of acute graft-versus-host disease. Leukemia. 2017 Apr;31(4):903-912. doi: 10.1038/leu.2016.281. Epub 2016 Oct 14. PMID 27740636