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

This study has been completed.
Sponsor:
Information provided by:
Ospedali Riuniti di Bergamo
ClinicalTrials.gov Identifier:
NCT01088724
First received: March 11, 2010
Last updated: March 16, 2010
Last verified: March 2010
History of Changes
  Purpose

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:

U.S. FDA Resources

Further study details as provided by Ospedali Riuniti di Bergamo:

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.

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01088724

Locations
Italy
Ospedali Riuniti di Bergamo
Bergamo, BG, Italy, 24121
Sponsors and Collaborators
Ospedali Riuniti di Bergamo
Investigators
Study Chair: Valentino Conter, MD Department of Pediatrics, Ospedali Riuniti di Bergamo
  More Information

No publications provided

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
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Fludarabine monophosphate
Rituximab
Fludarabine
Doxorubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
 Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Antimetabolites, Antineoplastic
Antimetabolites

ClinicalTrials.gov processed this record on May 16, 2013