Hematological Diseases Clinical Trial
Official title:
Study on Systemic and Airway Cytokines and Oxidative Stress in Patients Undergoing Haemopoietic Stem Cell Transplantation (HSCT)
Haemopoietic stem cell transplantation (HSCT) has become a major life-saving treatment for
many haematological conditions, mostly malignancies.
However, there are lots of potential complications that hinder the long-term success of
HSCT, in which bronchiolitis obliterans syndrome (BOS) is one of such serious complications.
Basically, BOS represents a form of graft-versus-host immunological damage of small airways
(bronchioles), leading to progressive narrowing of small airways and thus obstructive lung
function abnormalities. With progressive loss of lung function in BOS, patients after HSCT
can be complicated by intractable respiratory failure that results in mortality. Up until
now, there is still no reliable way to accurately predict or detect BOS early to allow
pharmacological interventions.
Therefore there is intense interest in the search for biomarkers that can help to predict
the occurrence of BOS after HSCT. Apart from biomarkers (e.g., cytokines) in blood, there
has been recent development in the sampling of airway lining fluid by a non-invasive method,
i.e., collection of exhaled breath condensate (EBC). In airway diseases such as asthma or
chronic obstructive pulmonary disease, EBC has been found to have various cytokines which
can serve as potential biomarkers of disease activity. Since BOS is largely a small airway
disease, it becomes logical to investigate the profile of biomarkers in EBC as predictors
for BOS after HSCT.
Therefore this study has been designed to look into the role of biomarkers in blood and EBC
in early detection of BOS after HSCT.
Haemopoietic stem cell transplantation (HSCT) has revolutionized the treatment of both
haematological and perhaps some solid malignancies. However, despite recent technological
advancements, HSCT is still associated with significant mortality and morbidities.
Apart from various infective complications in early stage post-HSCT, bronchiolitis
obliterans syndrome (BOS) has been a well-known late complication that can result in high
mortality. It has been mostly associated with those who develop chronic graft-versus-host
disease after allogeneic HSCT. Clinically, the diagnosis of BOS is largely based on
demonstration of obstructive lung function abnormalities and air-trapping in computed
tomography scan of thorax. Pathologically, bronchiolitis obliterans is characterized by both
inflammatory and fibrotic reactions in the small bronchioles leading to subsequent
obliteration. Upon diagnosis of BOS post-HSCT, inhaled corticosteroid (with or without
bronchodilators) is commonly prescribed as anti-inflammatory agent, though with undocumented
clinical efficacy. Unfortunately, there is still a lack of reliable biomarkers that can
predict or allow early detection of BOS, preferably in the early and potentially reversible
stage of development of BOS.
Apart from measuring circulating biomarkers in blood, exhaled breath condensate (EBC) has
recently emerged as a non-invasive sampling method for real-time analysis and evaluation of
oxidative stress biomarkers in the lower respiratory tract airways, especially in various
lung diseases including asthma, chronic obstructive pulmonary disease, and lung cancer. As
bronchiolitis obliterans is predominantly a disease of the small bronchioles, it is highly
likely to be associated with changes in various inflammatory and oxidative stress biomarkers
in EBC. However, the role of measuring EBC biomarkers in predicting the occurrence of BOS
after HSCT has not been studied. Therefore, the current study aims to evaluate the temporal
changes of various oxidative stress biomarkers and cytokines in EBC and blood in patients
with haematological conditions who undergo allogeneic HSCT, with regard to the subsequent
development of BOS.
;
Observational Model: Case Control, Time Perspective: Prospective
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT02240992 -
MSCs With or Without Peripheral Blood Stem Cell for Treatment of Poor Graft Function and Delayed Platelet Engraftment
|
Phase 2/Phase 3 | |
Recruiting |
NCT02241031 -
Megakaryocytic Progenitor Cells for Prophylaxis and Treatment of Thrombocytopenia
|
Phase 2/Phase 3 | |
Completed |
NCT02483325 -
Study Evaluating the Efficacy of Allogeneic Transplant Conditioning With Adaptive Dose Busulfan Intravenous (Busilvex®) in Patients at High Risk of Carrying Blood Diseases
|
Phase 2 | |
Recruiting |
NCT05041933 -
Secure Outsourcing of Carfilzomib in the Treatment of Multiple Myeloma to the Hospital at Home Setting
|
||
Completed |
NCT00675038 -
Pilot Study of Non-Invasive Assessment of Hepatic And Myocardial Iron Through T2* Magnet Resonance Imaging (MRI) In Patients With Iron Overload
|
N/A | |
Active, not recruiting |
NCT03745287 -
A Safety and Efficacy Study Evaluating CTX001 in Subjects With Severe Sickle Cell Disease
|
Phase 2/Phase 3 | |
Recruiting |
NCT05505760 -
Testing Content Delivery Models for MomConnect
|
N/A | |
Recruiting |
NCT00884364 -
Exercise During Chemotherapy for Patients With Hematological Malignancies
|
Phase 3 | |
Recruiting |
NCT01160952 -
Long-term Versus Short-term Sequential Therapy (Intravenous Itraconazole Followed by Oral Solution) of Itraconazole as Primary Prophylaxis in Patients Undergoing Allogeneic Stem Cell Transplantation
|
Phase 2 | |
Completed |
NCT00892502 -
Can Treatment With Bismuth Reduce Toxicity to Chemotherapy and Radiotherapy?
|
N/A | |
Active, not recruiting |
NCT00838643 -
Invasive Aspergillosis After Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
|
N/A | |
Recruiting |
NCT05329649 -
Evaluation of Safety and Efficacy of CTX001 in Pediatric Participants With Severe Sickle Cell Disease (SCD)
|
Phase 3 | |
Not yet recruiting |
NCT06281496 -
AlloCare - Support and Management of Late Effects After Allogeneic Hematopoietic Stem Cell Transplantation
|
N/A | |
Completed |
NCT02661035 -
Allo HSCT Using RIC for Hematological Diseases
|
Phase 2 | |
Enrolling by invitation |
NCT06277479 -
Late Effects and HRQoL in Survivors of Allo-HSCT - a Cross Sectional Study
|
||
Completed |
NCT01344681 -
Micafungin Versus Intravenous Itraconazole as Empirical Antifungal Therapy for Febrile Neutropenic Patients With Hematological Diseases
|
Phase 2 | |
Recruiting |
NCT02083718 -
Peripheral Blood Stem Cell Combined With Mesenchymal Stem Cells for Treatment of Poor Graft Function
|
Phase 2 | |
Recruiting |
NCT02083731 -
MSC for Treatment of CMV Infection
|
Phase 2 | |
Recruiting |
NCT01763086 -
Mesenchymal Stem Cells for Treatment of Poor Graft Function After Allogeneic Hematopoietic Stem Cell Transplant
|
Phase 2 | |
Recruiting |
NCT01763099 -
Mesenchymal Stem Cells Combined With Cord Blood for Treatment of Graft Failure
|
Phase 2 |