Fludarabine, Cyclophosphamide, Doxorubicin and Rituximab for the Treatment of Post-transplant Lymphoproliferative Disease (PTLD) (FCD-R)
|ClinicalTrials.gov Identifier: NCT01088724|
Recruitment Status : Completed
First Posted : March 17, 2010
Last Update Posted : March 17, 2010
|Condition or disease||Intervention/treatment||Phase|
|Post-transplant Lymphoproliferative Disease (PTLD) Non Burkitt||Drug: fludarabine, cyclophosphamide, doxorubicin, rituximab||Phase 4|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Fludarabine, Cyclophosphamide, Doxorubicin and Rituximab for the Treatment of Post-transplant Lymphoproliferative Disease (PTLD)|
|Study Start Date :||February 2002|
|Actual Primary Completion Date :||March 2010|
|Actual Study Completion Date :||March 2010|
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).
- Complete remission rate [ Time Frame: 6 months ]No evidence of disease
- graft rejection rate [ Time Frame: 1 year after treatment ]preservation of normal organ function
- Continuous complete remission rate [ Time Frame: five years after the diagnosis ]No evidence of disease
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01088724
|Ospedali Riuniti di Bergamo|
|Bergamo, BG, Italy, 24121|
|Study Chair:||Valentino Conter, MD||Department of Pediatrics, Ospedali Riuniti di Bergamo|