Status:
COMPLETED
Infusion of Donor Lymphocytes Transduced With the Suicide Gene HSV TK in Patients With Haematological Malignancies
Lead Sponsor:
AGC Biologics S.p.A.
Conditions:
Hematological Malignancies
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The aim of the study is to obtain immune reconsitutuion as well as reduction of infective episodes and disease relapse in patient with haematological malignancies who underwent SCT(and subsequent T ly...
Detailed Description
Delayed immune-reconstitution remains one of the main limitation of haploidentical stem cell transplantation. The risk of severe infections remains high for several months and CD4+ reconstitution coul...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT00423124
Start Date
July 1 2002
End Date
November 1 2013
Last Update
May 30 2014
Active Locations (8)
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1
Medizinische Hoschule Hannover
Hanover, Germany
2
G. Papanicolau
Thessaloniki, Greece
3
Hadassah University Hospital
Jerusalem, Israel
4
Fondazione San Raffaele
Milan, Italy