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Clinical Trial NCT06992934 (TARGETALLO) for Hematological Malignancies is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Immunological Impact of a Post Cell Therapy Treatment With FLT3 Inhibitors (TARGETALLO) 10 Cell Therapy

Not yet recruiting
Clinical Trial NCT06992934 (TARGETALLO) is an interventional study for Hematological Malignancies and is currently not yet recruiting. Enrollment is planned to begin on 1 August 2025 and continue until the study accrues 10 participants. Led by Centre Hospitalier Universitaire de Nice, this study is expected to complete by 1 August 2028. The latest data from ClinicalTrials.gov was last updated on 3 August 2025.
Brief Summary
Allogeneic hematopoietic stem cell transplantation (aHSCT) is the only curative option for many hematological maligancies. The main cause of death following HSCT is the relapse of the original disease.

Few strategies have been developed to prevent relapse after bone marrow transplantation. New prophylactic strategies are needed to decrease the relapse incidence without increasing the non-relapse mortality in the pos...

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Official Title

Non Interventional Study Aiming to Assess the Immunological Impact of a Post Cell Therapy Treatment With FLT3 Inhibitors on the Phenotype, the Metabolism, the Function of T-cells and Monocytes and Macrophages

Conditions
Hematological Malignancies
Other Study IDs
  • TARGETALLO
  • 22-AOI-11
NCT ID Number
NCT06992934
Start Date (Actual)
2025-08
Last Update Posted
2025-08-03
Completion Date (Estimated)
2028-08
Enrollment (Estimated)
10
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Primary Purpose
Basic Science
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalGilteritinib
Administration of Gliteritinib
Gilteritinib
Administration of Gilteritinib
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Assess the off-target effects of Gilteritinib on the phenotype of immunity cells
Evaluation of the phenotype
At 3 months, 6 months, 1 year post maintenance start
Assess the off-target effects of Gilteritinib on the function of immunity cells
Evaluation of the phenotype
At 3 months, 6 months, 1 year post maintenance start
Assess the off-target effects of Gilteritinib on the metabolism of immunity cells
Evaluation of the phenotype
At 3 months, 6 months, 1 year post maintenance start
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Overall survival after transplant
record of survival status
At 3 months post-transplant, 6 months, 1-year post
transplant relapse free survival
record of relapse event
At 3 months post-transplant, 6 months, 1-year post
aGVHD incidence
record of aGVHD event
At 3 months post-transplant, 6 months, 1-year post
cGVHD incidence
record of cGVHD event
At 3 months post-transplant, 6 months, 1-year post
Infection incidence
record of infection event
At 3 months post-transplant, 6 months, 1-year post
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • Patient > 18y/o
  • Patient who received an allogeneic stem cell transplantation for an acute myeloid leukemia and who will receive gilteritinib as post transplantation maintenance
  • Matched related, matched unrelated, mismatched unrelated and haploidentical donors

  • Minors
  • Pregnant women
  • Patient under 'tutelle', 'curatelle' or in prison
  • Patient who has been treated for a solid tumor in the past 2 years
  • Known human immunodeficiency virus (HIV) infection or HIV-related malignancy
  • Clinically active hepatitis B or hepatitis C infection
  • Known allergy or hypersensitivity to gilteritinib
Centre Hospitalier Universitaire de Nice logoCentre Hospitalier Universitaire de Nice
Study Central Contact
Contact: Michael LOSCHI, +334 92 03 55 58, [email protected]
1 Study Locations in 1 Countries
CHU de NICE, Nice, France
Michael LOSCHI, Contact, +334 92 03 55 58, [email protected]