A Randomized Multicenter Study to Compare Two Types of Transplant in Adult Patients With Hematologic Malignancies
A Randomized Multicenter Study to Compare Two Types of Transplant in Adult Patients With Hematologic Malignancies
This is an open-label, prospective, observational, multicenter, randomized study to compare
 the efficacy between unrelated umbilical cord blood transplantation (UCBT) and
 HLA-haploidentical related hematopoietic stem cell transplantation ,after myeloablative
 conditioning for adult patients with hematologic malignancies.
Inclusion Criteria:

 1. Age: subjects ≥ 18 and ≤ 55 years old.

 2. Patients without suitable matched related donor

 3. Diagnosed with acute leukemia or myelodysplastic syndrome in which allogeneic
 transplantation is considered the most potentially curative therapeutic option.

 4. Written consent form signed.

 Exclusion Criteria:

 -  Performance status: Eastern Cooperative Oncology Group(ECOG) score >2

 -  Prior allogenic hematopoietic stem cell transplant

 -  Left-ventricular ejection fraction at rest < 45%, uncontrolled arrhythmias or
 symptomatic heart failure.

 -  Diffusing capacity (DLCO) and/or forced vital capacity (FVC) < 39% of predicted values
 or symptomatic pulmonary disease

 -  Altered liver function tests (total bilirubin > 2 mg/dL and/or alanine
 aminotransferase, aspartate aminotransferase , and or active hepatitis or cirrhosis.

 -  Serum creatinine > 2 mg/dL or estimated creatinine clearance < 50 mL/min

 -  Evidence of uncontrolled bacterial, viral or fungal infection prior to the
 conditioning regimen

 -  Serious diseases that prevent patients from receiving chemotherapy treatments.

 -  Concomitant neoplasms.

 -  Pregnancy or breast-feeding.

 -  Any other medical, surgical or psychiatric condition that is considered by the
 attending and/or medical team as a contraindication for intensive treatment