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

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ClinicalTrials.gov Identifier: NCT02386332
Recruitment Status : Not yet recruiting
First Posted : March 11, 2015
Last Update Posted : March 11, 2015
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Hematologic Malignancies Procedure: transplantation

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Study Type : Observational
Estimated 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 : March 2015
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : March 2020

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



Primary Outcome Measures :
  1. Disease-Free Survival (DFS) [ Time Frame: 2 years ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02386332


Contacts
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Contact: Miguel A Sanz, MD +34.961.245875 msanz@uv.es

Sponsors and Collaborators
Instituto de Investigacion Sanitaria La Fe
Investigators
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Study Chair: Miguel A Sanz, MD University Hospital La Fe, Valencia

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Responsible Party: Instituto de Investigacion Sanitaria La Fe
ClinicalTrials.gov Identifier: NCT02386332     History of Changes
Other Study ID Numbers: TPH
First Posted: March 11, 2015    Key Record Dates
Last Update Posted: March 11, 2015
Last Verified: March 2015
Additional relevant MeSH terms:
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Neoplasms