Risk-stratified sequential treatment of post-transplant lymphoproliferative disease (PTLD) with 4 courses of rituximab SC followed by 4 courses of rituximab SC, 4 courses of rituximab SC combined with CHOP-21 or 6 courses of rituximab SC combined with alternating CHOP-21 and DHAOx: The PTLD-2 trial
- Conditions
- Previously untreated CD20-positive lymphoproliferative disorder (PTLD) following solid organ transplantationICD10 Version 2014: D47.Z1 Post-transplant lymphoproliferative disorder (PTLD)D47Other neoplasms of uncertain or unknown behaviour of lymphoid, haematopoietic and related tissue
- Registration Number
- DRKS00005380
- Lead Sponsor
- DIAKO Ev. Diakonie-Krankenhaus Bremen gGmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 60
• 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 incapacitated
• Written informed consent from the trial subject has been obtained
• Negative pregnancy test (females with child-bearing potential only; not required in postmenopausal women and permanently sterilised women)
• Use of highly-effective contraceptive methods during treatment and for 12 months following study therapy (this applies to female trial participants as well as female partners of male participants: females with child-bearing potential only)
• Complete surgical extirpation of the tumor or irradiation of residual tumor masses
• Missing data for IPI stratification
• Upfront treatment with rituximab or chemotherapy
• Known hypersensitivity to rituximab, murine proteins or to any of the excipients
• Concomitant diseases which exclude the administration of therapy as outlined by the study protocol, in particular:
severe heart failure (New York Heart Association Class IV), severe uncontrolled cardiac disease; HIV infection; other active, severe infections such as tuberculosis or Hepatitis B
• Meningeal and CNS involvement
• Pregnant women and nursing mothers
• 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
• Life expectancy less than 6 weeks
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - Event free survival (EFS) of low-risk patients in the intention to treat population defined as time from start of treatment to event with following definitions for low-risk and event:<br><br>1. Low-risk: <br>- all patients in complete remission at interim staging, i.e. 4 weeks after the four weekly courses of rituximab SC monotherapy<br>- all patients in partial remission at interim staging with an initial international prognostic index (IPI) of 0,1 or 2<br>- all patients in partial remission at interim staging with an negative PET scan*<br><br>2. Events:<br>- any grade III or IV infection during the treatment period<br>- treatment discontinuation from any reason<br>- disease progression at any time<br>- death from any reason<br>
- Secondary Outcome Measures
Name Time Method - Overall survival, time to progression, progression free survival, response at interim staging, response after full treatment, duration of response, treatment related mortality in the ITT and PP population <br>- Secondary end points will be analysed in the total trial cohort and by treatment group <br>