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PTLD-2

AcronymISRCTNEudraCTClinicaltrials.govDRKS
DPTLDSG-IIT-PTLD-22013-004479-11NCT02042391DRKS00005380

Risk-stratified sequential treatment of post-transplant lymphoproliferative diseases with 4 courses of rituximab SC followed by 4 courses of rituximab SC, 4 courcesof rituximab SC com-bined with CHOP-21 or 4 courses of rituximab SC combined with alternat-ing CHOP-21 and DHAOx: The PTLD-2 trail

Status: Active

Purpose / Objectives

Primary Outcome

  • determine safety and efficacy

Primary end point

Event free survival in low-risk patients with following definitions for low-risk and event:

1. Low-risk:

  • all patients in complete remission at interim staging, i.e. 4 weeks after the four weekly courses of rituximab SC monotherapy
  • all patients in partial remission at interim staging with an initial international prognostic index (IPI) of 0,1 or 2
  • all patients in partial remission at interim staging with an negative PET scan

2. Events:

  • any grade III or IV infection during the treatment period
  • treatment discontinuation from any reason
  • disease progression at any time
  • death from any reason

Secondary Outcomes

  • Response and overall response to the 4 initial doses of rituximab monotherapy, response and overall response to the overall therapy, duration of response, time to progression, progression-free survival, overall survival and treatment-related mortality in the intention-to-treat and per-protocol cohort
  • All secondary endpoints are investigated in the overall patient population and in the respective therapy groups.

Other variables:

  • Incidence of grade III and IV leukopenia and of grade III and IV infections in the respective therapy groups

Diagnosis

Untreated CD20-positive post-transplantation associated lymphoproliferative disease (PTLD) after transplantation of solid organs

Patient attributes

Age

18-99

Inclusion criteria

  • CD20-positive PTLD with or without EBV association, confirmed after biopsy or resection of tumor
  • Measurable disease of > 2 cm in diameter and/or bone marrow involvement
  • Patients having undergone heart, lung, liver, kidney, pancreas, small intestine transplantation or a combination of the organ transplantations mentioned
  • ECOG ≤ 2
  • Clinically insufficient response to an upfront reduction of immunosuppression with or without antiviral therapy
  • Age at least 18 years
  • Not legally incapcacitated
  • Written informed consent from the trial subject has been obtained
  • [...]

Exclusion criteria

  • Complete surgical exstirpation of the tumor or irradiation of residual tumor masses
  • Upfront treatment with rituximab or chemotherapy
  • Known allergic reactions against foreign proteins
  • Concomitant diseases, which exclude the administration of therapy as outlined by the study protocol
  • Meningeal and CNS involvement
  • Known to be HIV-positive
  • Pregnant women and nursing mothers
  • Failure to use highly-effective contraceptive methods
  • Persons held in an institution by legal or official order
  • Persons with any kind of dependency on the investigator or employed by the sponsor or investigator
  • [...]

Trial design

  • Phase II
  • Multicenter
  • Prospective
  • One-arm
  • Open Label

Intervention

All patients: 4 courses of rituximab SC

  • 375 mg/m2 rituximab IV (day 1)
  • 1400 mg rituximab SC (day 8, 15 and 22)

 

Low-risk patients: 4 courses of rituximab SC

  • 1400 mg rituximab SC (day 50, 71, 92 und 113)

High-risk patients: 4 courses of rituximab SC com-bined with CHOP-21

  • RSC-CHOP-21 + GCSF (Tag 50, 71, 92 und 113)

Very high-risk patients: 4 courses of rituximab SC combined with alternating CHOP-21 and DHAOx

  • RSC-CHOP-21 (day 50, 92, 134)
  • RSC-DHAOx-21 + GCSF (day 71, 113, 155)

Documents (password protected)

Responsibilities in overall trial

Evangelisches Diakoniekrankenhaus Bremen

National Coordinating Investigator

Prof. Dr. med. Ralf Ulrich Trappe

Study Sites

Klinik I für Innere Medizin

Study office

  • Klinisches Studienzentrum der Klinik I für Innere Medizin Köln

Status

Active

Principal Investigator

Priv.-Doz. Dr. med. Bastian von Tresckow

Deputy of Principal Investigator

  • Dr. med. Armin Tuchscherer

Subinvestigator

  • Dr. med. Anja Lohneis
  • Prof. Dr. med. Christian Pallasch

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