Phase II Study With Ga101-DHAP as Induction Therapy in Relapsed/Refractory DLBCL Patients

Inclusion Criteria

• •1. 18≥ Age \< 65
• •2. Relapsed/refractory disease after receiving one line of standard R-CHOP like chemotherapy
• •3. Diffuse Large B-cell Lymphoma at relapse. The re-biopsy is particularly recommended if relapse is over 1 year from previous complete remission. If this is harmful for the patient, the patient can be enrolled if archival tumor sample and block from first diagnosis are available.
• •4. Measurable and/or evaluable disease
• •5. Any Ann Arbor stage and IPI group at relapse
• •6. Performance status \< 2 according to Eastern Cooperative Oncology Group (ECOG) scale unless due to lymphoma
• •7. No Central Nervous System (CNS) disease (meningeal and/or brain involvement by lymphoma)
• •8. Adequate haematological counts: Absolute Neutrophil Count (ANC) \> 1.5 x 109/L, Hgb \> 10.5 g/dl (transfusion independent), Platelet count \> 75 x 109/L (transfusion independent), with the exception of cytopenia due to lymphoma bone marrow involvement
• •9. Normal liver function (ALP, AST, ALT, GGT, conjugated bilirubin total \< 2 x ULN) if not related to lymphoma
• •10. Normal kidney function (creatinine clearance \>= 80 ml/min)
• •11. Cardiac ejection fraction \> 50% (MUGA scan or echocardiography)
• •12. Normal lung function
• •13. Absence of active infections
• •14. Non peripheral neuropathy or active neurological non neoplastic disease of CNS
• •15. Non major surgical intervention prior 3 months to randomization if not due to lymphoma and/or not other disease life-threatening that can compromise chemotherapy treatment
• •16. Disease free of prior malignancies other than lymphoma for \> 3 years with exception of currently treated squamous cell and basal cell carcinoma of the skin or carcinoma in situ of the cervix or breast
• •17. Life expectancy \> 6 months
• •18. No psychiatric illness that precludes understanding concepts of the trial or signing ten informed consent
• •19. Written informed consent
• •20. Women must be:
• •1. postmenopausal for at least 1 year (must not have had a natural menses for at least 12 months)
• •2. surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy),
• •3. abstinent (at the discretion of the investigator/per local regulations), or
• •4. if sexually active, be practicing a highly effective method of birth control (eg, prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, double-barrier method (eg, condoms, diaphragm, or cervical cap, with spermicidal foam, cream, or gel, male partner sterilization) as local regulations permit, before entry, and must agree to continue to use the same method of contraception throughout the study. They must also be prepared to continue birth control measures for at least 18 months after terminating treatment.
• •21. Women of childbearing potential must have a negative serum or urine beta-human chorionic gonadotropin (beta-hCG) pregnancy test at screening
• •22. Men must agree to use an acceptable method of contraception (for themselves or female partners as listed above) for the duration of the study. Men must agree to use a double barrier method of birth control and to not donate sperm during the study and for 3 months after receiving the last dose of study drug.