|- candidate number||29306|
|- NTR Number||NTR7402|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||23-jul-2018|
|- Secondary IDs||201800427 UMCG register|
|- Public Title||Minimal residual disease monitoring in PTLD|
|- Scientific Title||Response assessment in post-transplant lymphoproliferative disorder with 18F-FDG-PET/CT and minimal residual disease monitoring, a multicenter multinational feasibility study|
|- hypothesis||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|
|- Healt Condition(s) or Problem(s) studied||Minimal residual disease, Circulating tumor DNA (ctDNA), 18F-FDG-CT, 18F-FDG-PET, Post-transplant lymphoproliferative disorder|
|- 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
- Patientís 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.
|- mec approval received||no|
|- multicenter trial||yes|
|- planned startdate ||1-okt-2018|
|- planned closingdate||1-okt-2021|
|- Target number of participants||30|
|- 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)
|- Timepoints||Diagnosis Interim, After 2x R-CHOP, End-of treatment |
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES|| Filipe Jesus|
|- CONTACT for SCIENTIFIC QUERIES|| Marcel Nijland|
|- Sponsor/Initiator ||University Medical Center Groningen (UMCG)|
(Source(s) of Monetary or Material Support)
|UMCG Kanker Researchfonds|
|- Brief 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.|
|- Main changes (audit trail)|
|- RECORD||23-jul-2018 - 9-aug-2018|