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Clinical Trials/NCT02386332
NCT02386332
Unknown
Not Applicable

A Randomized Multicenter Study Comparing Unrelated Umbilical-cord Blood Transplant Versus Human Leukocyte Antigen (HLA)-Haploidentical Related Hematopoietic Stem Cell Transplant for Adult Patients With Hematologic Malignancies

Instituto de Investigacion Sanitaria La Fe0 sites206 target enrollmentMarch 2015
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ConditionsHematologic Malignancies

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hematologic Malignancies
Sponsor
Instituto de Investigacion Sanitaria La Fe
Enrollment
206
Primary Endpoint
Disease-Free Survival (DFS)
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
March 2015
End Date
March 2020
Last Updated
11 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Instituto de Investigacion Sanitaria La Fe
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Age: subjects ≥ 18 and ≤ 55 years old.
  • •Patients without suitable matched related donor
  • •Diagnosed with acute leukemia or myelodysplastic syndrome in which allogeneic transplantation is considered the most potentially curative therapeutic option.
  • •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.

Outcomes

Primary Outcomes

Disease-Free Survival (DFS)

Time Frame: 2 years

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