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About
The hypothesis of the study is double unit umbilical cord blood transplantation in adults will be associated with a one year survival rate of at least 40%.
Enrollment
Sex
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Volunteers
Inclusion criteria
Age 22 - 50 years
Patients will have one of the following hematological malignancies:
Patients with adequate organ function and performance status criteria
Two Suitable Umbilical Cord Blood Units: a cryopreserved dose of at least 1.5 x 107 TNC/kg. If the unit contains red cells at time of cryopreservation, the cryopreserved dose must be at least 2.0 x 107 TNC/kg. Each unit must be at least 4/6 HLA-A and B antigen, and DRB1 allele matched with the recipient. Each unit must be at least 3/6 HLA-A, B DRB1 antigen matched to each other.
Exclusion criteria
Patient with suitable related donor
AML, ALL, AUL, biphenotypic leukemia beyond CR2
AML evolved from myelofibrosis
Any acute leukemia with:
Bone marrow aplasia (defined as BM cellularity < 5% at transplant work-up)
MDS with 10% or greater bone marrow blasts at pre-transplant workup
Prior autologous or allogeneic HSC transplant at any time
Prior radiation therapy rendering patient ineligible for TBI
Any uncontrolled infection at time of study enrollment
Seropositive or NAT positive for HIV or HTLV1
Females who are pregnant or breast feeding
Patient unable to give informed consent or unable to comply with the treatment protocol including appropriate supportive care, follow-up, and research tests
Primary purpose
Allocation
Interventional model
Masking
56 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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