NCT02386332

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
206

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2015

Longer than P75 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2015

Completed
3 days until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 11, 2015

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

March 11, 2015

Status Verified

March 1, 2015

Enrollment Period

4.9 years

First QC Date

February 26, 2015

Last Update Submit

March 5, 2015

Conditions

Hematologic Malignancies

Outcome Measures

Primary Outcomes (1)

  • Disease-Free Survival (DFS)

    2 years

Study Arms (2)

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

Interventions

transplantationPROCEDURE
HLA-haploidentical hematopoietic stem cell transplantationumbilical cord blood transplant (UCBT)

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Transplantation

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

  • Miguel A Sanz, MD

    University Hospital La Fe, Valencia

    STUDY CHAIR

Central Study Contacts

Miguel A Sanz, MD

CONTACT

+34.961.245875msanz@uv.es

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2015

First Posted

March 11, 2015

Study Start

March 1, 2015

Primary Completion

February 1, 2020

Study Completion

March 1, 2020

Last Updated

March 11, 2015

Record last verified: 2015-03