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

This study has been completed.
Information provided by:
A.O. Ospedale Papa Giovanni XXIII
ClinicalTrials.gov Identifier:
First received: March 11, 2010
Last updated: March 16, 2010
Last verified: March 2010
Fludarabine may be of benefit to prevent rejection of grafted solid organs in children during chemo-immunotherapy treatment for post transplant lymphoproliferative diseases (PTLDs).

Condition Intervention Phase
Post-transplant Lymphoproliferative Disease (PTLD)
Non Burkitt
Drug: fludarabine, cyclophosphamide, doxorubicin, rituximab
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Official Title: Fludarabine, Cyclophosphamide, Doxorubicin and Rituximab for the Treatment of Post-transplant Lymphoproliferative Disease (PTLD)

Resource links provided by NLM:

Further study details as provided by A.O. Ospedale Papa Giovanni XXIII:

Primary Outcome Measures:
  • Complete remission rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    No evidence of disease

  • graft rejection rate [ Time Frame: 1 year after treatment ] [ Designated as safety issue: No ]
    preservation of normal organ function

Secondary Outcome Measures:
  • Continuous complete remission rate [ Time Frame: five years after the diagnosis ] [ Designated as safety issue: No ]
    No evidence of disease

Enrollment: 4
Study Start Date: February 2002
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: chemotherapy Drug: fludarabine, cyclophosphamide, doxorubicin, rituximab
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).

Detailed Description:

Eligible to this study were patients less than 18 years old, presenting with non Burkitt, aggressive, CD20 positive PTLD, after solid organ transplants.

Induction therapy consisted of two cycles of a combination of Fludarabine(30mg/sqm/day, days 1,2,3), Cyclophosphamide (750 mg/sqm/day, day 1), Doxorubicin (30 mg/sqm/day, day 1)and Rituximab (375 mg/sqm/day, day 4).

Thereafter consolidation therapy was given as follows: two blocks for stage II or III with LDH less than 500 IU/L; three blocks for stage III with LDH >500 and < 1000 IU/L or stage IV with LDH < 1000 IU/L; four blocks for stage III or IV with LDH > 1000 IU/L. Blocks given were modified BFM blocks used for treatment of non Hodgkin B-lymphomas, as follows:

Block 1: High Dose Methotrexate (HDMTX) 1.5 gr/sqm; Vincristine (VCR,1.5 mg/sqm); Cytarabine (from 120 to 150 mg/sqm x4); Ifosfamide (600 mg/sqm/day x5); VP-16 (80 mg/sqm/day x2); Dexamethasone (DXM,10 mg/sqm/day for 5 ays); Intrathecal Methotrexate-Cytarabine-Methylprednisolone(TIT).

Block 2:HDMTX (3 gr/sqm); VCR (1.5 mg/sqm); Daunomycin (20 mg/sqm/day x2); Cyclophosphamide (160 mg/sqm/day x5); DXM (10 mg/sqm/day x5); TIT

Block 3:Vindesine (3 mg/sqm); Cytarabine (3000 mg/sqm q 12 hours x4); VP-16 (100 mg/sqm q 12 hours x4); DXM (20 mg/sqm/day x5);

Block 4 as Block 1.

Outcome measures are: achievement of complete remission after induction therapy; incidence of infectious episodes; neurological toxicity; incidence of graft rejection; duration of complete remission.


Ages Eligible for Study:   6 Months to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Children less 18 years old and
  • Non Burkitt, CD20 positive aggressive PTLD and
  • Solid organ transplant

Exclusion Criteria:

  • Burkitt PTLD
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01088724

Ospedali Riuniti di Bergamo
Bergamo, BG, Italy, 24121
Sponsors and Collaborators
A.O. Ospedale Papa Giovanni XXIII
Study Chair: Valentino Conter, MD Department of Pediatrics, Ospedali Riuniti di Bergamo
  More Information

Responsible Party: Eugenia Giraldi, Ospedali Riuniti di Bergamo, Italy
ClinicalTrials.gov Identifier: NCT01088724     History of Changes
Other Study ID Numbers: OORRPED 1 
Study First Received: March 11, 2010
Last Updated: March 16, 2010
Health Authority: Italy: Agenzia Italiana del Farmaco (AIFA)

Additional relevant MeSH terms:
Lymphoproliferative Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Fludarabine phosphate
Liposomal doxorubicin
Alkylating Agents
Antibiotics, Antineoplastic
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Physiological Effects of Drugs
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on May 24, 2016