Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05692713 |
| Other study ID # |
H22-03310 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2023 |
| Est. completion date |
June 30, 2025 |
Study information
| Verified date |
December 2023 |
| Source |
University of British Columbia |
| Contact |
Elena Ostroumov, PhD |
| Phone |
604-875-2000 |
| Email |
elena.ostroumov[@]bcchr.ca |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
Chronic graft-versus-host disease (cGvHD) is one of the most serious complications following
BMT (Bone Marrow Transplantation). cGvHD occurs when donor immune cells "attack" the tissues
and organs of the person receiving the BMT. cGvHD can be difficult to treat once it is
established leading to poor quality of life for recipients of a BMT. The goal of this study
is to determine if, by using biomarkers, the investigators can predict which patients are at
the highest risk of developing cGvHD after BMT, before cGvHD develops.
The ABLE3.0 / CTTC 2201 study will validate and potentially refine the initial predictive
biomarker algorithm developed from the original ABLE/PBTMC 1202 study (ABLE1.0), allowing
clinicians the ability to pre-emptively predict their patient's future risk of developing
both late-acute and chronic GvHD.
This will provide the foundation for the later development of clinical trials aimed at
reducing immune suppression quicker after transplant for low-risk patients (<10% risk) and
justifying more intensive approaches such as pre-emptive treatments before the onset of
chronic GvHD in high-risk patients (>45% risk).
Description:
320 adult transplant recipients will be enrolled in this study. The investigators will not
recruit healthy participants. Only those undergoing treatments from blood cancers and will be
having the transplant procedure will be offered to participate in this study. The control
participant group will be determined 12 months post-transplant. This group will consist of
those participants who did not develop either chronic or late acute GvHD one year after
transplantation.
The investigators will be enrolling allogeneic HCT patients before transplant up through Day
-1, following these patients prospectively until 12-months post-transplant for the
development of all forms of GvHD - classical acute (aGvHD), late acute (L-aGvHD), and chronic
(cGvHD), collecting blood samples and clinical data at day +60, day +100, and at the onset of
either L-aGvHD or chronic GvHD (but not classical acute GvHD before day +100). Two more blood
samples and clinical data will be collected from transplant recipients who never developed
any chronic or late-acute GVHD at the 6- and 12-month post-transplant time points. Case
Report Forms (CRFs) will be completed on the REDCap platform.
If chronic GvHD develops at any time after transplant (Day 0 to 1 year), or if any form of
GvHD occurs at or after day +100 (whether late acute, chronic GvHD, or overlap syndrome), a
blood sample will be drawn before escalating immune suppression, and the onset GvHD case
report form will be completed following the protocol. If chronic GvHD is confirmed, an
additional CRF will be submitted at 12-months post-transplant to document new cGvHD
manifestations, severity, and response to therapy.
A blood sample will not be collected and a CRF will not be completed if classical acute GvHD
occurs before Day 100. Staging and grading of classical acute GvHD however will occur on the
main case report forms.
On average, patients will have up to 4 blood samples drawn over the course of 1-year
post-transplant, depending upon their overall scenario, event and GvHD status.
For clinicians and site PIs, the primary responsibility will be monitoring patients for the
development of all forms of GvHD (classical acute, late acute, and chronic GvHD), including
accurate documentation, and near real-time reporting of detailed clinical data capture of
staging / grading / clinical features /severity and responses to therapy for patients with
late-acute and chronic GvHD.
Blood samples drawn from patients will be shipped to the Schultz Laboratory in Vancouver, BC,
Canada, processed and analyzed for cGvHD biomarkers. Cell phenotyping by flow cytometry will
be carried out on whole blood. Plasma will be used in ELISA, metabolomic analysis and
enzymatic assays. Blood cells will be used for B- and T- cell receptors research. A
statistical validation of the previously developed pediatric risk predictor in adult
population will be be performed based on the estimated overall frequency of cGvHD at 20% or
patients.
