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

Sponsor

Instituto de Investigacion Sanitaria La Fe (Other)

Overall Status

Unknown status

CT.gov ID

NCT02386332

Collaborator

(none)

206

Enrollment

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hematologic Malignancies	Procedure: transplantation

Study Design

Study Type:

Observational

Anticipated Enrollment :

206 participants

Time Perspective:

Prospective

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

Study Start Date :

Mar 1, 2015

Anticipated Primary Completion Date :

Feb 1, 2020

Anticipated Study Completion Date :

Mar 1, 2020

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Disease-Free Survival (DFS) [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Instituto de Investigacion Sanitaria La Fe

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Instituto de Investigacion Sanitaria La Fe

ClinicalTrials.gov Identifier:

NCT02386332

Other Study ID Numbers:

First Posted:

Mar 11, 2015

Last Update Posted:

Mar 11, 2015

Last Verified:

Mar 1, 2015

Additional relevant MeSH terms:

Neoplasms

Hematologic Neoplasms

Study Results

No Results Posted as of Mar 11, 2015