CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 55 enrolled
Drug / intervention
rituximab +3 morebiological
Likely dose
Rituximab IV (dose varies by age: <21 years 0.5-1.0 mg/kg/hr capped at 50 mg/hr, ≥21 years 50-100 mg/hr); Cyclophosphamide 600 mg/m² IV over 30-60 minutes on day 1 of each cycle; Methylprednisolone 0.8 mg/kg IV over 12 hours on days 1-5 of each cycle; Prednisone 1 mg/kg orally every 12 hours on days 1-5 of each cycleAI-extracted
Key inclusion· 7
  • ✓Histologically confirmed post-transplant lymphoproliferative disease (PTLD)
  • ✓CD20 positive AND Epstein-Barr virus positive
  • ✓Fulminant PTLD with fever >38°C, hypotension, and evidence of multiple organ involvement (at least 2 of: marrow, liver, lungs, GI tract hemorrhage)
  • ✓Non-fulminant PTLD with medically refractory disease after ≥50% reduction of immunosuppression for ≥1 week
Key exclusion· 3
  • ✕No PTLD central nervous system (CNS) disease, defined as positive cytology and/or radiographic evidence
  • ✕HIV negative required
  • ✕Not pregnant or nursing

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00066469
NCT00066469Phase 2Completed
CompareCT.gov

Phase II Study of Cyclophosphamide, Prednisone and Rituximab (CPR) in Children, Adolescents and Young Adults With B-lymphocyte Antigen CD20 (CD20) Positive Post-Transplant Lymphoproliferative Disease (PTLD) Following Solid Organ Transplantation (SOT)

Children's Oncology Group·interventional·Posted Aug 7, 2003·Updated Aug 6, 2019

In Brief

A Phase 2 clinical trial evaluating rituximab, cyclophosphamide, and 2 other interventions for Lymphoproliferative Disorder. Completed, enrolled 55 participants across 78 sites in 4 countries.

Detailed Summary

RATIONALE: Drugs used in chemotherapy such as cyclophosphamide, prednisone, and methylprednisolone use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining cyclophosphamide and either prednisone or methylprednisolone with rituximab may be effective in treating lymphoproliferative disease following organ transplantation. PURPOSE: Phase II trial to study the effectiveness of combining cyclophosphamide and either prednisone or methylprednisolone with rituximab in treating patients who have Epstein-Barr virus-positive lymphoproliferative disease following organ transplantation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLymphoproliferative Disorder
CountriesAustralia, Canada, New Zealand, United States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 7, 2003
Enrollment StartApr 1, 2004
Primary CompletionOct 1, 2009
Study CompletionDec 31, 2013
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 22.9 years ago

Interventions

rituximabbiological

Cycles 1 and 2 only: Given IV Incremental: First dosage: \< 21 years of age: 0.5mg/kg/hr (maximum of 50 mg/hr) for the 1st hour ≥ 21 years of age: 50 mg/hr for the 1st hour. Subsequent dosages: \< 21 years of age: 1.0mg/kg/hr (maximum of 50 mg/hr) for the 1st hour ≥ 21 years of age: 100 mg/hr for the 1st hour. Days 1, 8 and 15.

cyclophosphamidedrug

Given IV over 30-60 minutes Dose 600 mg/m2 in 50-250 mL of normal saline (NS) or Dextrose-Water 5%(D5W) (at a maximum concentration of 20 mg/ml) over 30-60 minutes on day 1 of each cycle

methylprednisolonedrug

Methylprednisolone 0.8 mg/kg IV over 12 hours on days 1,2,3,4 and 5 of each cycle.

prednisonedrug

Dosage 1 mg/kg orally every 12 hours on days 1,2,3,4 and 5 of each cycle. Oral prednisone may be rounded up to the nearest 2.5 mg as necessary for tablet size