Back to resultsFludarabine, Cyclophosphamide, Doxorubicin and Rituximab for the Treatment of Post-transplant Lymphoproliferative Disease (PTLD) (FCD-R)
Primary Purpose
Post-transplant Lymphoproliferative Disease (PTLD), Non Burkitt
Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
fludarabine, cyclophosphamide, doxorubicin, rituximab
Sponsored by
About this trial
This is an interventional treatment trial for Post-transplant Lymphoproliferative Disease (PTLD)
Eligibility Criteria
Inclusion Criteria:
- Children less 18 years old and
- Non Burkitt, CD20 positive aggressive PTLD and
- Solid organ transplant
Exclusion Criteria:
- Burkitt PTLD
Sites / Locations
- Ospedali Riuniti di Bergamo
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
chemotherapy
Arm Description
Outcomes
Primary Outcome Measures
Complete remission rate
No evidence of disease
graft rejection rate
preservation of normal organ function
Secondary Outcome Measures
Continuous complete remission rate
No evidence of disease
Full Information
NCT ID
NCT01088724
First Posted
March 11, 2010
Last Updated
March 16, 2010
Sponsor
A.O. Ospedale Papa Giovanni XXIII
1. Study Identification
Unique Protocol Identification Number
NCT01088724
Brief Title
Fludarabine, Cyclophosphamide, Doxorubicin and Rituximab for the Treatment of Post-transplant Lymphoproliferative Disease (PTLD)
Acronym
FCD-R
Official Title
Fludarabine, Cyclophosphamide, Doxorubicin and Rituximab for the Treatment of Post-transplant Lymphoproliferative Disease (PTLD)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
February 2002 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
A.O. Ospedale Papa Giovanni XXIII
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-transplant Lymphoproliferative Disease (PTLD), Non Burkitt
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
chemotherapy
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
fludarabine, cyclophosphamide, doxorubicin, rituximab
Intervention Description
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).
Primary Outcome Measure Information:
Title
Complete remission rate
Description
No evidence of disease
Time Frame
6 months
Title
graft rejection rate
Description
preservation of normal organ function
Time Frame
1 year after treatment
Secondary Outcome Measure Information:
Title
Continuous complete remission rate
Description
No evidence of disease
Time Frame
five years after the diagnosis
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children less 18 years old and
Non Burkitt, CD20 positive aggressive PTLD and
Solid organ transplant
Exclusion Criteria:
Burkitt PTLD
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valentino Conter, MD
Organizational Affiliation
Department of Pediatrics, Ospedali Riuniti di Bergamo
Official's Role
Study Chair
Facility Information:
Facility Name
Ospedali Riuniti di Bergamo
City
Bergamo
State/Province
BG
ZIP/Postal Code
24121
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Fludarabine, Cyclophosphamide, Doxorubicin and Rituximab for the Treatment of Post-transplant Lymphoproliferative Disease (PTLD)
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