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

MolMed0 个研究点目标入组 70 人开始时间: 2007年4月12日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•- 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

•- 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

发起方

MolMed