Chronic Graft Versus Host Disease
Conditions
Keywords
Chronic GvHD
Brief summary
Graft versus Host Disease (GvHD), in both its acute and chronic forms, is the major intrinsic complication of allogeneic hematopoeitic stem cell transplant (allo-HSCT). Moreover, chronic GvHD may be regarded as a late effect of cancer therapy, and the severity of chronic GvHD is the chief determinant of long-term survival following allo-HSCT. Unfortunately, the investigators understanding (and thus management) of chronic GvHD is not optimal; a recent NIH Consensus Conference has defined inadequacies in virtually all facets of chronic GvHD management. Notably for this study, the lack of suitable biomarkers compromises diagnosis, staging and therapeutic response evaluation of chronic GvHD - and also hinders better understanding of the biology of this process. In particular, the activity of chronic GvHD is often difficult to discern, potentially causing either undertreatment, with the risk of morbidity and/or mortality due to uncontrolled chronic GvHD, or possibly overtreatment, with potent ISTs causing unnecessary toxicity. Obviously, the development of reliable biomarkers of chronic GvHD activity would be a very useful advance in addressing this problem, as well as other facets of management not addressed due to certain limitations, as detailed herein. Potentially, certain imaging technologies could address this problem. To date, imaging technology has been used only sporadically in chronic GvHD and is not an integral part of routine assessments. However, and despite its nonspecific nature, certain inflammatory features of some chronic GvHD cases, plus clinical similarity to certain autoimmune diseases in which functional imaging has been tested in research trials - (and perhaps notably), a limited experience in acute GvHD - the investigators postulate that Positron emission tomography - computed tomography (PET-CT) scans may be useful as a biomarker of disease activity in chronic GvHD. This protocol is an initial effort to that end.
Interventions
OTHERPET-CT Scan
PET-CT scan will be done at baseline (per standard of care), at onset and confirmation of chronic GvHD and after initiation of therapy to assess response.
Sponsors
University of Rochester
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Prior allogeneic hematopoietic stem cell transplant (+/- DLI) * As per current recommendations, no interval from allo HSCT will be required to differentiate acute from chronic Graft versus Host Disease (GvHD) * Patients must have had negative routine restaging PET-CT scans * Patients may not have had any more than two weeks' specific treatment for chronic GvHD. (It is recognized that some patients develop chronic GvHD while on immunosuppressive prophylaxis; such patients will remain eligible, even if dose adjustment of these prophylactic agents occurs. The two week interval pertains to the use of additional agents in this case.) * Diagnosis of chronic GvHD must be confirmed. In the usual case, tissue biopsy will be required; however, some chronic GvHD patients do not require tissue biopsy for confirmation. The PI and co-investigator must agree on eligibility. * Per patient approval by PI and one additional co-investigator * Informed consent
Exclusion criteria
* Patients with a malignancy not in remission will be excluded. * Negative routine pregnancy testing. Patients either pregnant or unwilling to use satisfactory contraception (if appropriate) will not be eligible. All female patients must use a highly effective birth control method or a combination of 2 additionally effective birth control methods while in this study. Examples of highly effective birth control are: a condom or a diaphragm with spermicidal jelly, oral, injectable, or implanted birth control, or abstinence.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To determine ability of PET-CT scans to delineate and stage initial chronic GvHD | At initial diagnosis of chronic GvHD | Assessment to take place after confirmed diagnosis of chronic GvHD but before initiation of therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To determine ability of PET-CT scans to document response to chronic GvHD therapy | PET-CT performed </= 6 months from study PET-CT #1 | Therapy for chronic GvHD can be standard of care or investigational. Maximal response to treatment is defined as stability on two occasions \>/= one month apart; PET-CT to be performed within two weeks of this assessment. Initial PET-CT at diagnosis will be used as the comparison. |
Countries
United States
Outcome results
None listed