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About
This is an open label, interventional, randomized phase II trial comparing StemRegenin-1 (SR-1) cultured umbilical cord blood (experimental arm) to unmanipulated umbilical cord blood (standard of care arm) transplantation after a myeloablative CY/FLU/TBI conditioning. A 2:1 randomization will be employed with a higher chance of being assigned to the experimental arm.
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Inclusion criteria
Must have a partially HLA matched UCB unit with a pre-cryopreserved TNC dose >2.5 x 107 per kilogram recipient weight. HLA matching is initially based on 4 of 6 HLA-A and B (at low or intermediate resolution by molecular typing) and DRB1 (at high resolution by molecular typing).
Eligible Diseases
Acute myelogenous leukemia (AML) at the following stages:
Acute lymphocytic leukemia (ALL) at the following stages:
High risk first remission.
High risk second CR based on institutional criteria (eg, for children, bone marrow relapse <36 months from induction or T-lineage bone marrow relapse or very early isolated central nervous system (CNS) relapse <6 months from diagnosis, or slow re-induction (stage M2-3 at day 28 after induction) regardless of length remission.
Any third or subsequent CR.
Biphenotypic/undifferentiated leukemia in CR
Chronic myelogenous leukemia (CML) excluding refractory blast crisis
Myelodysplasia (MDS) IPSS Int-2 or High risk (i.e. RAEB, RAEBt) or refractory anemia
Other Inclusion Criteria
Karnofsky score >70% (16 years and older) or a Lansky play score >70 (children <16 years) - appendix II
Adequate organ function defined as:
Available 'back-up' HSPC graft (e.g, second partially HLA matched UCB unit, haploidentical related donor).
Voluntary written consent signed (adult or parental) before performance of any study-related procedure not part of normal medical care
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
0 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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