No registrations found.
ID
Source
Health condition
Circulating tumor DNA
Post-transplant lymphoproliferative disorder
18F-flurodeoxyglucose positron emission tomography/computed tomography
Minimal residual disease
Sponsors and support
Intervention
Outcome measures
Primary outcome
Detection of ctDNA at diagnosis and response evaluation
Secondary outcome
- Sensitivity and specificity of plasma ctDNA genotyping in comparison with tumor sample DNA (gDNA) as gold standard
- Changes in ctDNA abundance throughout therapy
- Clinical end-points: progression free survival (PFS), overall survival (OS), event free survival (EFS), disease specific survival (DSS)
Background summary
Post-transplant lymphoproliferative disorder (PTLD) is a serious complication after solid organ (SOT) and hematopoietic stem cell transplantation (HSCT), associated with significant morbidity and mortality. Initial treatment consists of tapering immune suppression and rituximab monotherapy. 18F-flurodeoxyglucose positron emission tomography/computed tomography (18F-FDG-PET/CT) has become the main tool to assess remission status, drive decisions on treatment alteration and identify relapse in patients with PTLD. In case of positive 18F-FDG-PET/CT following rituximab, treatment is escalated with R-CHOP. However 18F-FDG-PET/CT false positives results are commonly reported and it has limited prognostic value (positive predictive value of 38% negative predictive value of 92%). Minimal residual disease (MRD) from circulating tumor DNA (ctDNA) fragments occurs under the detection threshold of 18F-FDG-PET/CT. With a blood sample one may be able to monitor MRD, thought to be responsible for disease progression and relapse. MRD may become an early response indicator used to guide treatment. We will investigate the feasibility of MRD monitoring in PTLD patients and perform an exploratory study to evaluate if MRD monitoring may be used to trace disease status during treatment and identify early responders from (non-) responders.
Study objective
MRD detection using next generation sequencing (NGS) on circulating tumor DNA (ctDNA) from PTLD patients using a gene panel previously used in diffuse large B-cell lymphoma (DLBCL) may be feasable
Study design
Diagnosis Interim, After 2x R-CHOP, End-of treatment
Intervention
None
Inclusion criteria
- Patients having undergone a SOT or HSCT
- Histologically proven CD20+ monomorphic PTLD (with or without EBV association),
- Age > 18 years
- Intent to treat patient according to standard protocol (rituximab / R-CHOP). Clinicians are allowed to adapt protocol in the best interest of the patient
- Measurable disease on 18F-FDG-PET/CT at diagnosis according to the Lugano classification 2014
- Patient’s written informed consent and written consent for data collection.
Exclusion criteria
- A complete surgical resection of tumor.
- Upfront treatment with external beam radiation therapy.
- Involvement of the central nervous system by the disease.
- Known to be HIV positive.
- Iatrogenic immunodeficiency lymphomas other than PTLD.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7203 |
| NTR-old | NTR7402 |
| Other | UMCG register : 201800427 |