EUCTR2013-003628-35-ITActive, not recruitingNot Applicable
A COMBINATION THERAPY COMPRISING A 'MEGADOSE' OF T CELL DEPLETED HEMATOPOIETIC STEM CELL TRANSPLANT POST-TRANSPLANT CYCLOPHOPHAMIDE AND A REDUCED INTENSITY CONDITIONING FOR A STABLE AND LONG TERM ENGRAFTMENT - T CELL DEPLETED HSCT, REDUCED INTENSITY CONDITIONING AND POST-TRANSPLANT CYCLOPHOPHAMIDE
Azienda Ospedaliero-Universitaria di Parma0 sites10 target enrollmentStarted: September 19, 2013Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 10
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •- age between 18 and 70; - Diagnosis according to the WHO classification: CLL patients with refractoriness to fludarabine or other chemotherapy due to the p53 loss by 17p deletion and/or TP53 mutation; Follicular lymphoma with either unfavourable cytogenetics such as complex karyotype, del17p, del 6q23-26, mutations in TP53, minus 1p; Hodgkin's Lymphoma relapsed after autologous transplantation, not elegible for immunotherapy with anti-CD30- Multiple myeloma relapsing after autologous transplantation, with unfavourable cytogenetics in either partial or complete remission. Non available
- •matched unrelated donor.Availability of haploidentical family donor; patients has an Eastern Cooperative Oncology Group (ECOG) performance status = 2; understands and voluntarily signs an informed consent form, skilled in adhering to the study visit schedule and other protocol requirements; creatinine clearance <1,5 or GFR >30 ml/min-
- •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 9
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1
Exclusion Criteria
- •- age <18 and >70; - creatinine clearance >1,5 or GFR <30 ml/min ; -
- •cardiac ejection fraction <40%; - presence of second malignancies ; -
- •Patient has a known history of HIV seropositivity; - Patient has active
- •HBV hepatitis. The following categories of HBV positive patients but with
- •non evidence of active hepatitis may be considered for the study:
- •HBsAg+ and HBV DNA <2000 UI/mL (inactive carriers);HBV DNA >2000
- •UI/mL is criteria of exclusion, Patient is HBsAg- HBsAb+ Patient is
- •HBsAg- HBcAb+ Patients with HCV active hepatitis are excluded from the
- •study, Psychiatric problems, Inability to provide informed consent
Investigators
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