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

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

Status
Unknown
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON52048
Enrollment
15
Registered
2022-05-05
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

graft failure graft versus host disease and impaired hematopoietic stem cell proliferation

Interventions

None listed

Sponsors

Swedish Orphan International
Lead Sponsor

Eligibility

Age
No minimum to 99 Years

Inclusion criteria

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

Exclusion criteria: • HLH patients • Body weight

Design outcomes

Primary

MeasureTime frame
For HSCT cohort: To investigate the relationship between IFNγ levels and IFNγ activity by measuring CXCL9 levels and the risk of graft failure For IHSCP cohort: To investigate the IFNγ levels and IFNγ activity by measuring CXCL9 levels in patients with impaired HSC proliferation pre-transplant.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)