A clinical study to investigate Interferon gamma (IFN*) signature in patients post HSCT and in patients with impaired HSC proliferation pre-transplant

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 15

Inclusion Criteria

• The patient must have consented to the use of their clinical data and
biological samples for research investigations.
• In HSCT cohort:
- Patients with underlying:
I. non-malignant hematological disease (e.g. autoimmune and metabolic
disorders, aplastic
anemia, Sickle cell anemia, Fanconi anemia, Diamond-blackfan anemia,
thalassemia,
osteopetrosis, Wiskott-Aldrich syndrome, severe combined immunodeficiency)
or
II. malignant disease with higher risk of GF, i.e. Acute Myeloid Leukemia (AML)
and Acute
Lymphoblastic Leukemia (ALL) with primary induction failure, second partial
remission or
relapse* Chronic Myeloid Leukemia (CML) in blastic phase (circulating blast or
blast above 5%
in biopsy)* Non Hodgkin and Hodgkin Lymphoma and multiple myeloma with primary
induction failure, second partial remission or relapse, myelodysplastic
syndromes (MDS) and
myeloproliferative disorders (MPD) with splenomegaly, myelofibrosis with portal
hypertension pre-transplant, MDS/MPD overlap syndromes
- and who received allogeneic HSCT and are at higher risk of graft failure
based on at least one of the following criteria:
I. Having received reduced intensity conditioning (RIC) or non myeloablative
conditioning (NMA)
combined with a non-malignant disease or having received graft from Bone Marrow
(BM)
II. Ex vivo T cell depleted graft
III. Graft from mismatched unrelated donor or
haploidentical donor
IV. Graft from Umbilical Cord Blood (UCB)
• In the IHSCP cohort:
- Patients with IHSCP pre-transplant (e.g. aplastic anemia)

Exclusion Criteria

• HLH patients
• Body weight < 10kg

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>For HSCT cohort: To investigate the relationship between IFNγ levels and IFNγ<br /><br>activity by measuring CXCL9 levels and<br /><br>the risk of graft failure<br /><br><br /><br>For IHSCP cohort: To investigate the IFNγ levels and IFNγ activity by measuring<br /><br>CXCL9 levels in patients with impaired HSC proliferation pre-transplant.</p><br>

Secondary Outcome Measures