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Feasibility 'innate' allogeneic stem cells transplantion


- candidate number21704
- NTR NumberNTR5013
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR19-feb-2015
- Secondary IDs48606 NL48606.000.14
- Public TitleFeasibility 'innate' allogeneic stem cells transplantion
- Scientific TitleTowards a novel immune therapy platform with an innate allogeneic haematopoietic stem cell transplantation in patients with haematological malignancies
- ACRONYM
- hypothesisPatients suffering from high risk or relapsed leukaemia or high risk MDS can only occasionally be cured with conventional chemotherapy. Allogeneic stem cell transplantation (allo-SCT) has substantially improved the outcome of such patients due to a potent graft versus leukaemia effect after transplantation, however still for the high price of severe and life-threatening GVHD. Also relapses are frequently observed after allo-SCT. Recent reports have shown that the innate immune system can contribute to tumor control, whereas the development of GVHD appears to by lower as has been observed after conventional allo-SCT. An "Innate-Tx" is a alpha/beta T cell depleted allograft, in which the innate immune cells are still present. The hypothesis is that via the depletion of the alpha/beta T cells the incidence of aGVHD will be lower, but that the remaining innate cells will provide infection and tumor control.
- Healt Condition(s) or Problem(s) studiedHematological malignancy, Allogeneic stem cell transplantation, Innate immunity
- Inclusion criteriaAdults
Haematological malignancies eligible to allo-SCT
WHO performance status ≤ 2
Written informed consent
- Exclusion criteriaRelapse of allo-SCT within 6 months after allo-SCT
Bilirubin and/or transaminases > 2.5 x normal value
Creatinine clearance < 40 ml/min
Cardiac dysfunction as defined by (Unstable angina; Unstable cardiac arrhythmias)
Active, uncontrolled infection
- mec approval receivedno
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-apr-2015
- planned closingdate1-apr-2019
- Target number of participants35
- InterventionsReduced toxicity myeloablative conditioning regime, alpha beta T-cell depleted stem cell graft.
- Primary outcomeIncidence of aGVHD at day 100.
- Secondary outcomeTreatment related mortality (TRM) at day 100
Donor engraftment (chimerism > 95%) at day 100
- TimepointsEnd of study day 100
Time follow up 2 years
- Trial web site
- status[default]
- CONTACT FOR PUBLIC QUERIESProf J Kuball
- CONTACT for SCIENTIFIC QUERIES
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Utrecht (UMCU)
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD19-feb-2015 - 10-apr-2015


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