A pilot study to assess the feasibility of unrelated umbilical cord blood transplantation with coinfusion of third-party mesenchymal stem cells after myeloablative or nonmyeloablative conditioning in adult patients with hematological malignancies.
- Conditions
- Adult patients with hematological malignancies
- Registration Number
- EUCTR2009-011817-26-BE
- Lead Sponsor
- Z Brussel VUB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 20
Patient inclusion criteria:
Age 15-60 yrs with following diseases
Allogeneic stem cell transplantation is the preferred treatment option:
High risk acute myeloid leukemia (AML) in first complete remission (CR)
High risk acute lymphoblastic leukemia (ALL) in first CR
Acute leukemia in second or third remission
High risk myelodysplastic syndrome: IPSS Intermediate-2 or high risk
Advanced lymphoproliferative disorders
Chronic myeloid leukemia
Multiple myeloma
Informed consent given
Are the trial subjects under 18? yes
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) no
F.1.3.1 Number of subjects for this age range
Patient exclusion criteria
Previous allogeneic transplant
Progressive malignant disease
Significant organ damage as a contraindication to allotransplantation
Creatinine clearance < 60 ml/min
AST/ALT > 3x normal value and/or serum bilirubin > 3 mg/dL
Cardiac failure (LVEF < 50%)
Clinical relevant pulmonary disease: DLCO < 50% normal
Significant psychiatric or neurological disorder
Uncontrolled viral, fungal or bacterial infection
Pregnancy
HIV positive
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method