Fludarabine, Cyclophosphamide, Doxorubicin and Rituximab for the Treatment of Post-transplant Lymphoproliferative Disease (PTLD)

Sponsor: A.O. Ospedale Papa Giovanni XXIII
Study ID: NCT01088724
Phase: PHASE4
Status: Completed

Conditions

Non Burkitt
Post-transplant Lymphoproliferative Disease (PTLD)

Eligibility Criteria

Sex: ALL
Age: 6 Months - 18 Years
Healthy Volunteers: Not accepted

Interventions

fludarabine, cyclophosphamide, doxorubicin, rituximab — DRUG
Fludarabine i.v.(30 mg/sqm/day,day 1,2,3); Cyclophosphamide i.v.(750 mg/sqm, day 1); Doxorubicin i.v.(30 mg/sqm, day 1); Rituximab i.v. (375 mg/sqm, day 4).

Study Details

Fludarabine may be of benefit to prevent rejection of grafted solid organs in children during chemo-immunotherapy treatment for post transplant lymphoproliferative diseases (PTLDs).

Key Dates

Start date: Feb 28, 2002
Status verified: Mar 2010
Primary completion: Mar 31, 2010
Completion: Mar 31, 2010

Study Design

Enrollment: 4 participants (actual)
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Arms

Experimental: chemotherapy

Primary Outcome Measure

Complete remission rate [ Time Frame: 6 months ]