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

• Conditions: Hematologic Malignancies
• Interventions: Procedure: transplantation

• Registration Number: NCT02386332
• Lead Sponsor: Instituto de Investigacion Sanitaria La Fe

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-02-26
• Status Verified: 2015-03
• Study Start: 2015-03
• Study First Submitted QC: 2015-03-05
• Last Update Submitted: 2015-03-05
• Study First Posted: 2015-03-11
• Last Update Posted: 2015-03-11
• Primary Completion: 2020-02
• Study Completion: 2020-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 206

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
umbilical cord blood transplant (UCBT)	transplantation	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
HLA-haploidentical hematopoietic stem cell transplantation	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

Primary Outcome Measures

Name	Time	Method
Disease-Free Survival (DFS)	2 years