Evaluation of Immunological Reconstitution After Haploidentical Bone Marrow Transplantation

June 28, 2013 updated by: Armando Santoro, MD

Evaluation of Immunological Reconstitution After Haploidentical Bone Marrow Transplantation Using a Nonmyeloablative Preparative Regimen and Post-transplant Cyclophosphamide, in Patients With Poor Prognosis Lymphomas

Evaluation of immunological reconstitution after haploidentical BMT using a nonmyeloablative preparative regimen and post-transplant cyclophosphamide in patients with poor prognosis lymphoma

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Actual)

23

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • MI
      • Rozzano, MI, Italy, 20089
        • Istituto Clinico Humanitas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with lymphoma (any histology)

Description

Inclusion Criteria:

  • Patients with lymphoma (any histology) relapsed after high dose chemotherapy and in partial remission, complete remission or stable disease after the last CT line that
  • Signed informed consent to perform an haploidentical allo-BMT using a nonmyeloablative preparative regimen and post-transplant cyclophosphamide

Exclusion Criteria:

none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluation of T lymphocytes and NK cells absolute number
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of discrete T-cells populations
Time Frame: 1 year
Evaluation, by flow cytometry, of discrete T cell populations, including CD4+ and CD8+ TN, TSCM, TCM and TEM, NK and NKT cells, B cells, dendritic cell subsets
1 year
Evaluation of antigen-specific T cell populations
Time Frame: 1 year
Evaluation of antigen-specific T cell frequency towards CMV, EBV and influenza virus by MHC tetramers
1 year
Evaluation of antigen-specific T lymphocyte's functionality
Time Frame: 1 year
antigen-specific T lymphocyte's functionality towards tumor cell line evaluated using a degranulation assay
1 year
Evaluation of cytokines production by IL-2 and anti-CD16 activated NK cells
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Armando Santoro, MD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Anticipated)

December 1, 2013

Study Completion (Anticipated)

December 1, 2013

Study Registration Dates

First Submitted

May 27, 2013

First Submitted That Met QC Criteria

June 28, 2013

First Posted (Estimate)

July 3, 2013

Study Record Updates

Last Update Posted (Estimate)

July 3, 2013

Last Update Submitted That Met QC Criteria

June 28, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ONC/OSS-04/2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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