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

March 5, 2015 updated by: Instituto de Investigacion Sanitaria La Fe

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

206

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Miguel A Sanz, MD
  • Phone Number: +34.961.245875
  • Email: msanz@uv.es

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
umbilical cord blood transplant (UCBT)
Patients to receive umbilical cord blood transplant (UCBT) are conditioned with the myeloablative conditioning regimen (preparative therapy with thiotepa, fludarabine, intravenous busulfan and anti-thymocyte globulin.). Also receive GVHD prophylaxis with cyclosporine A and prednisone and Additional Supportive Care
Procedure: transplantation
HLA-haploidentical hematopoietic stem cell transplantation
Patients to receive HLA-haploidentical hematopoietic stem cell transplantation are conditioned with the myeloablative conditioning regimen (preparative therapy with thiotepa, fludarabine, intravenous busulfan). Also receive GVHD prophylaxis with cyclophosphamide, cyclosporine A and mycophenolate mofetil and Additional Supportive Care
Procedure: transplantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Disease-Free Survival (DFS)
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto de Investigacion Sanitaria La Fe

Investigators

  • Study Chair: Miguel A Sanz, MD, University Hospital La Fe, Valencia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Anticipated)

February 1, 2020

Study Completion (Anticipated)

March 1, 2020

Study Registration Dates

First Submitted

February 26, 2015

First Submitted That Met QC Criteria

March 5, 2015

First Posted (Estimate)

March 11, 2015

Study Record Updates

Last Update Posted (Estimate)

March 11, 2015

Last Update Submitted That Met QC Criteria

March 5, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TPH

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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