A Randomized Multicenter Study to Compare Two Types of Transplant in Adult Patients With Hematologic Malignancies

Hematologic Malignancies Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02386332
• Other study ID #: TPH
• Status: Not yet recruiting
• Phase: Phase 3
• First received: February 26, 2015
• Last updated: March 5, 2015
• Start date: March 2015
• Est. completion date: March 2020

Study information

• Verified date: March 2015
• Source: Instituto de Investigacion Sanitaria La Fe
• Contact: Miguel A Sanz, MD
• Phone: +34.961.245875
• Email: msanz[@]uv.es
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 206
• Est. completion date: March 2020
• Est. primary completion date: February 2020
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Hematologic Malignancies
• Neoplasms

Intervention

Procedure:
• transplantation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Investigacion Sanitaria La Fe

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-Free Survival (DFS)		2 years	Yes