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

Post-transplant Lymphoproliferative Disease (PTLD) Clinical Trial

— FCD-R  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01088724
• Other study ID #: OORRPED 1
• Status: Completed
• Phase: Phase 4
• First received: March 11, 2010
• Last updated: March 16, 2010
• Start date: February 2002
• Est. completion date: March 2010

Study information

• Verified date: March 2010
• Source: A.O. Ospedale Papa Giovanni XXIII
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Agenzia Italiana del Farmaco (AIFA)
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 18 Years

Eligibility

Inclusion Criteria:

• Children less 18 years old and

• Non Burkitt, CD20 positive aggressive PTLD and

• Solid organ transplant

Exclusion Criteria:

• Burkitt PTLD

Study Design

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

Related Conditions & MeSH terms

• Lymphoproliferative Disorders
• Non Burkitt
• Post-transplant Lymphoproliferative Disease (PTLD)

Intervention

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).

Locations

Country	Name	City	State
Italy	Ospedali Riuniti di Bergamo	Bergamo	BG

Sponsors (1)

Lead Sponsor	Collaborator
A.O. Ospedale Papa Giovanni XXIII

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete remission rate	No evidence of disease	6 months	No
Primary	graft rejection rate	preservation of normal organ function	1 year after treatment	No
Secondary	Continuous complete remission rate	No evidence of disease	five years after the diagnosis	No