Infusion of Donor Lymphocytes Transduced With the Suicide Gene HSV TK in Patients With Haematological Malignancies

Inclusion Criteria:

* Patients \>=18 years old affected by hematological malignancies at high risk of relapse based on disease progression or presence of negative prognostic factors, who have received a HCT from donor HLA mismatched (haploidentical) for 2 or 3 loci
* Engraftment documented by \>500 neutrophils/µl for three consecutive days in the absence of growth factors
* Mixed chimerism or full donor chimerism confirmed
* AML in 1st or 2nd relapse or primary refractory
* High-risk AML in 1st or subsequent remission
* RAEB and RAEB-T
* CML in 2nd chronic phase, blast crisis or accelerated phase
* Poor prognosis ALL in 1st or subsequent remission
* High grade lymphomas in 3rd or subsequent remission
* Multiple myeloma in advanced stage relapsing or progressing after high dose chemotherapy
* Absence of fully HLA matched or one HLA locus mismatched family donor
* Stable clinical conditions and life expectancy \>3 months
* PS Karnofsky \>70
* Written donor/patient informed consent

Exclusion Criteria:

* Infection with cytomegalovirus being treated with ganciclovir
* Presence of GvHD grade \> I that requires systemic immunosuppressive therapy (at baseline)
* Ongoing systemic immunosuppressive therapy
* Ongoing acyclovir administration
* Administration after haplo-HCT of G-CSF and cyclosporine A
* CD3+ lymphocytes \>100/µl before day +42 after haplo-HCT
* Life-threatening condition or complication other than their basic disease
* CNS disease
* Pregnant or lactating women