Immune Mediated Disorders After Allogeneic Hematopoietic Cell Transplantation
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Bronchitis, Neurology, Orthopedic, Pulmonary, Hematology |
| Therapuetic Areas: | Hematology, Neurology, Pulmonary / Respiratory Diseases, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/21/2016 |
| Start Date: | March 2011 |
| End Date: | September 2016 |
Longitudinal Study of Immune Mediated Disorders After Allogeneic Hematopoietic Cell Transplantation (HCT)
The purpose of this research study is to better understand the onset and course of graft
versus host disease (GVHD)and other immune-mediated disorders after stem cell transplant.
versus host disease (GVHD)and other immune-mediated disorders after stem cell transplant.
Allogeneic hematopoietic cell transplantation (HCT) is the only known curative option for
many hematologic disorders. After transplantation, many patients develop immune mediated
disorders that may be life-threatening such as graft versus host disease (GVHD). The
morbidity and mortality associated with HCT-associated immune mediated disorders are major
barriers to successful use of transplantation to cure rare hematologic malignancies such as
leukemia, lymphoma, multiple myeloma, myelodysplastic/myeloproliferative syndromes amongst
other diseases.
With this study, the investigators will investigate the biologic basis for immune mediated
disorders after allogeneic HCT, focusing on those developing cutaneous sclerosis,
bronchiolitis obliterans syndrome, late acute GVHD and chronic GVHD. The study will enroll
1118 (1018 adults and 100 children) allogeneic HCT patients over a three year period.
Subjects will be followed for two years and monitored closely for development of immune
mediated disorders. This study will have 5 study visits at day 1, 100, 180, 365, and 730.
During these visits, a physical assessment, medication review, blood and urine collection
will occur.
If a subject develops an immune mediated disordered, they will be monitored at 3 months, 6
months, 1 year and then annually from the date of diagnosis. During these study visits, a
physical assessment, IMD status, and medication review as well as blood and urine collection
will occur.
many hematologic disorders. After transplantation, many patients develop immune mediated
disorders that may be life-threatening such as graft versus host disease (GVHD). The
morbidity and mortality associated with HCT-associated immune mediated disorders are major
barriers to successful use of transplantation to cure rare hematologic malignancies such as
leukemia, lymphoma, multiple myeloma, myelodysplastic/myeloproliferative syndromes amongst
other diseases.
With this study, the investigators will investigate the biologic basis for immune mediated
disorders after allogeneic HCT, focusing on those developing cutaneous sclerosis,
bronchiolitis obliterans syndrome, late acute GVHD and chronic GVHD. The study will enroll
1118 (1018 adults and 100 children) allogeneic HCT patients over a three year period.
Subjects will be followed for two years and monitored closely for development of immune
mediated disorders. This study will have 5 study visits at day 1, 100, 180, 365, and 730.
During these visits, a physical assessment, medication review, blood and urine collection
will occur.
If a subject develops an immune mediated disordered, they will be monitored at 3 months, 6
months, 1 year and then annually from the date of diagnosis. During these study visits, a
physical assessment, IMD status, and medication review as well as blood and urine collection
will occur.
Inclusion Criteria:
- Planned or completed first allogeneic stem cell transplant (any conditioning regimen,
graft source, donor type and GVHD prophylaxis regimen)
- Signed, informed consent and, if applicable, child assent
Exclusion Criteria:
- Inability to comply with study procedures
- Anticipated survival less than 6 months due to co-morbid disease
- Autoimmune disorder or inherited immunodeficiency before HCT
- Diagnosis of late acute or chronic GVHD prior to study enrollment
- Hematologic relapse or chemotherapy refractory disease at restaging within 1 month of
HCT or at the time of enrollment (e.g., > 5% blasts for leukemia; poorly responsive
lymphoma)
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