Actively Recruiting

Phase 2
Phase 3
Age: 1Year - 75Years
All Genders
NCT03818334

Post Transplant Cyclophosphamide in Matched Unrelated Donor Stem Cell Transplantation for Hematological Malignancies

Led by Hospital Israelita Albert Einstein · Updated on 2019-02-01

50

Participants Needed

1

Research Sites

416 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study aims to evaluate the clinical efficacy of cyclophosphamide in patients receiving a bone marrow graft from a matched unrelated donor in overall survival, progression free survival and cumulative incidence of acute and chronic GvHD. Thirty patients will receive cyclophosphamide while twenty patients will receive antihuman T-lymphocyte immune globulin (ATG).

CONDITIONS

Official Title

Post Transplant Cyclophosphamide in Matched Unrelated Donor Stem Cell Transplantation for Hematological Malignancies

Who Can Participate

Age: 1Year - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Men and women of any age
  • Indication for hematopoietic stem cell transplant (HSCT) without a matched sibling donor
  • Availability of a matched unrelated donor (HLA 10 x 10 or 9 x 10)
  • Diagnosis of hematological malignancy
Not Eligible

You will not qualify if you...

  • Acute leukemias not in complete response (more than 5% blasts in bone marrow)
  • Chemorefractory lymphoproliferative disease
  • Active uncontrolled infection
  • Hematopoietic cell transplantation-comorbidity index (HCT-CI) greater than 3
  • Severe organ dysfunction including heart ejection fraction less than 45%, glomerular filtration rate less than 50 mL/hour, or pulmonary DLCO less than 50%
  • Prior allogeneic bone marrow transplantation
  • Contraindication to cyclophosphamide or ATG

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Hospita Israelita Albert Eintein

São Paulo, São Paulo, Brazil, 05652-900

Actively Recruiting

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Research Team

A

Andreza A Feitosa Ribeiro

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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