Sequential Treatment of CD20-positive Posttransplant Lymphoproliferative Disorder (PTLD)
- Sponsor
- Charite University, Berlin, Germany
- Study ID
- NCT01458548
- Phase
- PHASE2
- Status
- Terminated
Conditions
- Post-transplantation Lymphoproliferative Disorder
Eligibility Criteria
- Sex
- ALL
- Age
- 16 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Rituximab — DRUGRituximab 375 mg/m2 IV on days 1, 8, 15 and 22.
- CHOP — DRUGCyclophosphamide 750 mg/m2 IV, adriamycine 50 mg/m2 IV, vincristine 1.4mg/m2 IV, and prednisone 50mg/m2 PO every 3 weeks at days 50, 72, 94 and 116.
Study Details
Post-transplantation lymphoproliferative disorder (PTLD) develops in one to ten per cent of transplant recipients and can be EBV-associated. To improve long-term efficacy after rituximab monotherapy and to avoid the toxicity of CHOP seen in first-line treatment, the investigators initiated an international multicentre phase II trial to test whether the subsequent application of rituximab and four courses of three-weekly CHOP would improve the outcome of patients with PTLD: PTLD-1, sequential treatment (ST).
Key Dates
- Start date
- Dec 31, 2002
- Status verified
- Oct 2011
- Primary completion
- May 31, 2008
- Completion
- Oct 31, 2011
Study Design
- Enrollment
- 70 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Primary Outcome Measure
number of patients with complete and partial remission [ Time Frame: 1 month (plus or minus 7 days) after the last cycle of chemotherapy ]