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

Tracking Information

First Received Date ^ICMJE

March 11, 2010

Last Updated Date

March 16, 2010

Start Date ^ICMJE

February 2002

Primary Completion Date

March 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01088724 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Continuous complete remission rate [ Time Frame: five years after the diagnosis ] [ Designated as safety issue: No ]

No evidence of disease

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Primary Purpose: Treatment

Condition ^ICMJE

Post-transplant Lymphoproliferative Disease (PTLD)
Non Burkitt

Intervention ^ICMJE

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).

Study Arm (s)

Experimental: chemotherapy

Intervention: Drug: fludarabine, cyclophosphamide, doxorubicin, rituximab

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

March 2010

Primary Completion Date

March 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

Burkitt PTLD

Gender

Both

Ages

6 Months to 18 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Italy

Administrative Information

NCT Number ^ICMJE

NCT01088724

Other Study ID Numbers ^ICMJE

OORRPED 1

Has Data Monitoring Committee

Responsible Party

Eugenia Giraldi, Ospedali Riuniti di Bergamo, Italy

Study Sponsor ^ICMJE

Ospedali Riuniti di Bergamo

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Valentino Conter, MD

Department of Pediatrics, Ospedali Riuniti di Bergamo

Information Provided By

Ospedali Riuniti di Bergamo

Verification Date

March 2010

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

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