Fludarabine, Cyclophosphamide, Doxorubicin and Rituximab for the Treatment of Post-transplant Lymphoproliferative Disease (PTLD) (FCD-R)
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|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|