Chronic Myeloid Leukemia MedDRA version: 18.0 Level: LLT Classification code 10054352 Term: Chronic phase chronic myeloid leukemia System Organ Class: 100000004864
Conditions
Interventions
Trade Name: BOSULIF - 100 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PVC/ACLAR/PVC) - 30 COMPRESSE
Product Name: BOSULIF
Product Code: PF-05208763
Pharmaceutical Form: Tablet
INN or Prop
Sponsors
UNIVERSITà DEGLI STUDI MILANO BICOCCA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 1. Chronic Myeloid Leukaemia -CML- in chronic phase (CP) 2. Failure to achieve at least a Major Cytogenetic Response (MCyR) after a minimum of 18 months of TKIs treatment 3. Inability to tolerate 3 months of uninterrupted full dose TKIs therapy due to hematological toxicity 4. A minimum of three treatment interruptions due to hematological toxicity Availability of a HLA-identical related donor (Matched Related Donor, MRD) 5. Availability of unrelated donor (Matched Unrelated Donor, MUD) satisfying the criteria of a 10/10 antigen match at HLA-A, -B, -C and - DRB1, -DQB1 at high resolution typing, or 9/10 with a permissive – DP disparity according to Fleischhauer model (Crocchiolo et al, Blood 2009) 6. Target graft size (bone marrow): 7. bone marrow: > 3 x 106 CD34+ cells/kg BW recipient or > 3 x 108 nucleated cells/kg BW 8. Karnofsky Index = 80 % 9. Age =18 and =70 years 10. Adequate contraception in female patients of child-bearing potential 11. Written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 14 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 6
Exclusion criteria
Exclusion criteria: • 1. Secondary malignancies 2. A hematopoietic cell transplantation-specific comorbidity index (Sorror et al Appendix C) > 4 3. Known and manifested malignant involvement of the CNS 4. Active infectious disease 5. Active HIV, HBV or HCV infection 6. Impaired liver function (Bilirubin > upper normal limit; Transaminases > 3.0 x upper normal limit) 7. Impaired renal function (Creatinine-clearance 1.5 x upper normal limit). 8. Pleural effusion or ascites > 1.0 L 9. Pregnancy or lactation 10. Known hypersensitivity to Busilvex and/or fludarabine 11 Non-co-operative behaviour or non-compliance 12 Psychiatric diseases or conditions that might impair the ability to give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of complete cytogenetic responses (CCyR) at 12 months post transplant, based on at least 20 metaphases ;Secondary Objective: Efficacia - Valutazione di attecchimento - Valutazione della sopravvivenza complessiva (OS) - Valutazione delle risposte molecolari - Valutazione di incidenza di recidiva (RI) - Documentazione del chimerismo del donatore il giorno 28, 56 e 100 Sicurezza - Valutazione di incidenza di mortalità senza ricadute (NRM) al giorno 28 e 360 - Valutazione di incidenza cumulativa e della gravità di malattia acuta e cronica vs host disease (GvHD). Qualità di Vita - Valutazione della Qualità di Vita con EQ-5D-5L (Italiano - Versione 2) and FACT-Leu (Italiano - Versione 4) allo screening, al giorno -6, +100, al mese 6, 12 e a fine trattamento. Fine del totale follow-up per OS, PFS, RI, NRM, cGVHD = 2 anni dopo il trapianto del paziente dell'ultimo paziente arruolato;Primary end point(s): Complete Cytogenetic Response;Timepoint(s) of evaluation of this end point: 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Overall Survival Relapse Incidence Donor chimerism Non Relapse Mortality Incidence of Acute and Chronic Graft vs Host Disease Quality of Life;Timepoint(s) of evaluation of this end point: 2 years after transplantation of the last patient included day 28, 56 and 100 screening, day 6, day 100, month 6, month 12 and End of Study | — |
Countries
Italy
Contacts
Public ContactProf. Carlo Gambacorti-Passerini -
Università degli Studi di Milano Bicocca
Outcome results
None listed