Status:
TERMINATED
A Clinical Study to Investigate Interferon Gamma (IFNɣ) Signature in Patients Post HSCT and in Patients With Impaired HSC Proliferation Pre-transplant
Lead Sponsor:
Swedish Orphan Biovitrum
Collaborating Sponsors:
PRA Health Sciences
Cytel Inc.
Conditions:
Graft Failure
Eligibility:
All Genders
Brief Summary
Clinical study designed to collect blood for research purposes in patients after hematopoietic stem cell transplantation (HSCT) or in patients with a medical condition where the blood cells production...
Detailed Description
This clinical study is designed to investigate IFNγ activity in two cohorts of patients. * First group will include patients post HSCT at risk of graft failure (GF) based on their underlying diseases...
Eligibility Criteria
Inclusion
- 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
- HLH patients
- Body weight \< 10kg
Key Trial Info
Start Date :
November 16 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 31 2022
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT04494061
Start Date
November 16 2020
End Date
August 31 2022
Last Update
October 21 2022
Active Locations (25)
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1
Algemeen Ziekenhuis Delta - Campus Rumbeke
Roeselare, West-Vlaanderen, Belgium, 8800
2
Cliniques Universitaires Saint-Luc
Brussels, Belgium, 1200
3
Centre Hospitalier Universitaire Grenoble Alpes
La Tronche, Auvergne-Rhône-Alpes, France, 38700
4
Hôpital Côte De Nacre
Caen, Basse-Normandie, France, 14033