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

NCT ID: NCT02386332

Last Updated: 2015-03-11

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 206 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2020-03-31

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.

Conditions

Hematologic Malignancies

Study Design

• Study Time Perspective: PROSPECTIVE

Study Groups

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

transplantation

Intervention Type: PROCEDURE

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

transplantation

Intervention Type: PROCEDURE

Interventions

transplantation

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto de Investigacion Sanitaria La Fe

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Miguel A Sanz, MD

Role: STUDY_CHAIR

University Hospital La Fe, Valencia

Central Contacts

Miguel A Sanz, MD

Role: CONTACT

msanz@uv.es

+34.961.245875

Other Identifiers

TPH

Identifier Type: -

Identifier Source: org_study_id