Thiotepa, Busulfan and Fludarabin for pt With Refractory/Early Relapsed Aggressive B-cell Non Hodgkin Lymphomas

Launched by AZIENDA OSPEDALIERA SAN GIOVANNI BATTISTA · Feb 6, 2013

Keywords

ClinConnect Summary

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

* Patients with refractory/relapsed aggressive B-cell non Hodgkin lymphomas after frontline therapy.
* Patients with stable disease or partial or complete remission (PET-negative) after salv...

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Eligibility criteria

• Patient inclusion criteria:
• • Patients with refractory/relapsed aggressive B-cell non Hodgkin lymphomas after frontline therapy.
• • Patients with stable disease or partial or complete remission (PET-negative) after salvage therapy
• • Patients younger than 65 years old
• • A fully HLA-identical sibling or matched unrelated donor is available. Patients with one antigen mismatched donors can be considered
• • Patient must be competent to give consent.
• 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:
• • Cardiac function: ejection fraction \<30% or uncontrolled cardiac failure
• • Pulmonary: DLCO \<40% predicted
• • Liver function abnormalities: elevation of bilirubin to \> 3 mg/dl and/or transaminases \>4x the upper limit of normal
• • Renal: creatinine clearance \<50 cc/min (24 hour urine collection)
• • 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:
• • Related or unrelated HLA identical donors who are in good health and have no contra-indication to donation. One antigen HLA-mismatched (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 mg/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.