A phase I-II study: infusion of donor lymphocytes transduced with the suicide gene HSV TK, after transplantation of allogeneic T-depleted stem cells from a haploidentical donor in patients with haematological malignancies - TK007

• Conditions: Hematological malignancies at high risk of relapse based on disease progression or presence of negative prognostic factor, who have received a HCTfrom donor HLA mismatched (haploidentical) for 2 or 3 loci.

• Registration Number: EUCTR2005-003587-34-GR
• Lead Sponsor: MolMed

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04-12
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 70

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 SCT from a HLA mismatched (haploidentical) donor for 2 or 3 loci
- Engraftment verified 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
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Infection with Cytomegalovirus being treated with ganciclovir
- Presence of GvHD grade > I that requires systemic immunosuppressive therapy
- Ongoing systemic immunosuppressive therapy
- Ongoing acyclovir administration
- Administration after SCT of G-CSF and cyclosporine A
- CD3+ lymphocytes >=100/µl before day +42 after SCT
- Patients with life-threatening condition or complication other than their basic disease.
- Patients with CNS disease
- Pregnant or lactating women

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: ? Evaluation of clinical activity in terms of immune reconstitution after SCT<br>? Evaluation of the in vivo control of GvHD after administration of ganciclovir in patients treated with HSV-tk transduced cells<br>? Evaluation of GvL effect;Secondary Objective: ? Disease free survival and overall survival<br>? Incidence of infectious events<br>? Acute and long-term toxicity related to the infusions<br>;Primary end point(s): The primary endpoints of the trial is to evaluate the clinical activity in terms of immune reconstitution after SCT, to evaluate the in vivo control of GvHD after administration of ganciclovir and to evaluate the GvL effect.