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About
The purpose of this study is to evaluate progression free survival, transplant-related morbidity (TRM) at day +100 and at +365, overall survival and incidence of acute and chronic GVHD in refractory/early relapsed aggressive B-cell non Hodgkin lymphomas patients treated with allogeneic Transplantation after a conditioning with Thiotepa, Busulfan and fludarabin.
Full description
In the present study, it is hypothesised that patients with aggressive B cell lymphomas refractory to or relapsed early (within 12 months) after the completion of standard first-line immunoProtocol TBF2012 Version 1, 20 Nov 2012 9 chemotherapy can benefit from de-bulking salvage therapy (i.e. R-DHAP + bortezomib) followed by an allograft to improve progression-free survival.
Patient inclusion criteria
Patient exclusion criteria
Patients treated with an autologous transplant as salvage therapy
Patients with progressive lymphomas despite conventional therapies
Patients with progressive lymphomas despite conventional therapies
Uncontrolled CNS involvement with disease
Fertile men or women unwilling to use contraceptive techniques during and for 12 months following treatment
Females who are pregnant or breastfeeding
Organ dysfunction defined as follows:
Karnofsky performance score < 60%
Patients with poorly controlled hypertension despite multiple antihypertensives
Documented fungal disease that is progressive despite treatment
Viral infections: HIV positive patients.
Positive serology for Hepatitis B (HB) defined as a positive test for HBsAg. In addition, if negative for HBsAg but HBcAb positive (regardless of HBsAb status), a HBV DNA test will be performed and if positive the subject will be excluded.
Positive serology for hepatitis C (HC) defined as a positive test for HCAb, in which case reflexively perform a HC RIBA immunoblot assay on the same sample to confirm the result
Psychiatric disorders or psychosocial problems which in the opinion of the primary physician or Principal Investigator would place the patient at unacceptable risk from this regimen.
Patients with active non-hematologic malignancies (except nonmelanoma skin cancers).
Patients with a history of non-hematologic malignancies (except non-melanoma skin cancers) currently in a complete remission, who are less than 5 years from the time of complete remission, and have a >20% risk of disease recurrence. Donor inclusion criteria:
Related or unrelated HLA identical donors who are in good health and have no contra-indication to donation. One antigen HLAmismatched (9/10 match) donors will also be considered.
No contra-indication for the donor to collection by apheresis of mononuclear cells mobilized by G-CSF at a dose of 10-12 μg/kg of body weight.
Donor must have adequate veins for leukapheresis or agree to placement of central venous catheter (femoral, subclavian). Donor exclusion criteria:
Age < 18 years.
Identical twin.
Pregnancy.
Infection with HIV.
Inability to achieve adequate venous access.
Known allergy to filgrastin (G-CSF).
Current serious systemic illness.
Donor inclusion criteria:
Donor inclusion criteria:
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Patient inclusion criteria:
Patient exclusion criteria:
Patients treated with an autologous transplant as salvage therapy
Patients with progressive lymphomas despite conventional therapies
Patients with progressive lymphomas despite conventional therapies
Uncontrolled CNS involvement with disease
Fertile men or women unwilling to use contraceptive techniques during and for 12 months following treatment
Females who are pregnant or breastfeeding
Organ dysfunction defined as follows:
Karnofsky performance score < 60%
Patients with poorly controlled hypertension despite multiple antihypertensives
Documented fungal disease that is progressive despite treatment
Viral infections: HIV positive patients.
Positive serology for Hepatitis B (HB) defined as a positive test for HBsAg. In addition, if negative for HBsAg but HBcAb positive (regardless of HBsAb status), a HBV DNA test will be performed and if positive the subject will be excluded.
Positive serology for hepatitis C (HC) defined as a positive test for HCAb, in which case reflexively perform a HC RIBA immunoblot assay on the same sample to confirm the result
Psychiatric disorders or psychosocial problems which in the opinion of the primary physician or Principal Investigator would place the patient at unacceptable risk from this regimen.
Patients with active non-hematologic malignancies (except non-melanoma skin cancers).
Patients with a history of non-hematologic malignancies (except non-melanoma skin cancers) currently in a complete remission, who are less than 5 years from the time of complete remission, and have a >20% risk of disease recurrence.
Donor inclusion criteria:
Donor exclusion criteria:
Primary purpose
Allocation
Interventional model
Masking
42 participants in 1 patient group
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Central trial contact
Benedetto Bruno, MD; Benedetto Bruno, MD
Data sourced from clinicaltrials.gov
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