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:
A.O. Ospedale Papa Giovanni XXIII
ClinicalTrials.gov Identifier:
NCT01088724
First received: March 11, 2010
Last updated: March 16, 2010
Last verified: March 2010

March 11, 2010
March 16, 2010
February 2002
March 2010   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01088724 on ClinicalTrials.gov Archive Site
Continuous complete remission rate [ Time Frame: five years after the diagnosis ] [ Designated as safety issue: No ]
No evidence of disease
Same as current
Not Provided
Not Provided
 
Fludarabine, Cyclophosphamide, Doxorubicin and Rituximab for the Treatment of Post-transplant Lymphoproliferative Disease (PTLD)
Fludarabine, Cyclophosphamide, Doxorubicin and Rituximab for the Treatment of Post-transplant Lymphoproliferative Disease (PTLD)

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

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.

Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
  • Post-transplant Lymphoproliferative Disease (PTLD)
  • Non Burkitt
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).
Experimental: chemotherapy
Intervention: Drug: fludarabine, cyclophosphamide, doxorubicin, rituximab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4
March 2010
March 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Burkitt PTLD
Both
6 Months to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01088724
OORRPED 1
No
Eugenia Giraldi, Ospedali Riuniti di Bergamo, Italy
A.O. Ospedale Papa Giovanni XXIII
Not Provided
Study Chair: Valentino Conter, MD Department of Pediatrics, Ospedali Riuniti di Bergamo
A.O. Ospedale Papa Giovanni XXIII
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP