Low-Dose Total Lymphoid Irradiation in Treating Patients With Refractory Chronic Graft-versus-Host Disease After Donor Stem Cell Transplant
Stopped early · Not applicable
Conditions studied: Graft Versus Host Disease
In brief
This phase I trial studies the side effects and best dose of low-dose total lymphoid irradiation (LD-TLI) in treating patients with chronic graft-versus-host disease that has not responded to treatment with steroids. LD-TLI is a procedure in which all of the body's major lymph nodes are treated with small doses of radiation in order to reset the dysfunctional immune system. LD-TLI may work as a treatment for graft-versus-host disease caused by a bone marrow or stem cell transplant.
Key facts
- Study ID
- NCT02109809
- Run by
- Wake Forest University Health Sciences
- People needed
- 4
- Starts
- 2014-07-01
- Expected to finish
- 2016-09-01
- Last updated by the study team
- 2018-11-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients may have received a prior allogeneic hematopoietic stem cell transplant (alloHSCT) for any indication and from any donor
- Patients must have a diagnosis of cGvHD, in accordance with National Institutes of Health (NIH) guidelines; patients with "overlap syndrome" are also eligible; NOTE: Patients with recurrent, late onset and/or persistent acute GvHD (alone) are not eligible
- Patients with chronic GvHD who have been exposed to two or more lines of therapy, including at least one of which was composed of a glucocorticoid and a calcineurin inhibitor are eligible.
- Patients must have active, but not rapidly progressive, refractory cGvHD; any degree of severity (as per NIH criteria) and/or pattern of organ involvement may be considered; that said, patients with more severe and/or extensive chronic GvHD are expected to be the usual candidates for therapy
- As above, GvHD should be controlled to a degree that would potentially allow no additional requirement for systemic IST before and following TLI =< -15 and >= day (d) +45, respectively
- The ability to administer protocol doses of TLI (i.e., 100, 200 or 300 cGy) without exceeding cumulative doses of radiation must be established; for patients with prior radiotherapy exposure, this determination will be made by Dr. Greven (or her designee) using published guidelines for excessive organ exposure
- Karnofsky performance status (KPS) >= 60%
- White blood cells >= 3,000/mcL
- Absolute neutrophil count >= 1,500/mcL
- Hemoglobin >= 10.0 g/dL
- Platelets >= 100,000/mcL
- NOTE: If such hematologic abnormalities are present and deemed due to the process of cGvHD, such requirements may be waived with the approval of the PI
- Patients must have non-hematologic organ function as defined below:
- Left ventricular ejection fraction (LVEF) > 40%
- Key pulmonary function tests (PFTs) > 40%
- No further criteria for non-hematologic organ function are specified; however, if moderate-to-severe (major) organ function is present, such should be discussed with the PI, as various degrees of non-hematologic organ dysfunction may compromise either (or both) outcomes and toxicity evaluation
- If there is concern regarding potential reversibility of any specific organ dysfunction, this issue should be addressed by consultation with an appropriate sub-specialist
- Ability to understand and the willingness to sign an institutional review board (IRB)-approved informed consent document
You may not qualify if…
- Patients with evidence of persistent or active malignancy or uncontrolled infection at the time of study entry
- Patients who are pregnant or breastfeeding
Where it is running
- Comprehensive Cancer Center of Wake Forest University — Winston-Salem, North Carolina, United States
Full record on ClinicalTrials.gov
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