Conditioning with Thiotepa, Busulfan and Fludarabin following allogeneic Transplantation in refractory or relapsed non Hodgkin lymphomas patients

• Conditions: Refractory/early relapsed aggressive B-cell non Hodgkin lymphomas; MedDRA version: 14.1Level: PTClassification code 10003899Term: B-cell lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-005378-73-IT
• Lead Sponsor: FONDAZIONE NEOPLASIE SANGUE ONLUS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01-11
• Last Update Posted: 5 August 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 42
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified