Evaluation of Immunological Reconstitution After Haploidentical Bone Marrow Transplantation

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01891578
• Other study ID #: ONC/OSS-04/2010
• Status: Active, not recruiting
• Phase: N/A
• First received: May 27, 2013
• Last updated: June 28, 2013
• Start date: January 2011
• Est. completion date: December 2013

Study information

• Verified date: June 2013
• Source: Istituto Clinico Humanitas
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 23
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Lymphoma

Locations

Country	Name	City	State
Italy	Istituto Clinico Humanitas	Rozzano	MI

Sponsors (1)

Lead Sponsor	Collaborator
Armando Santoro, MD

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of T lymphocytes and NK cells absolute number		1 year	No
Secondary	Evaluation of discrete T-cells populations	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	No
Secondary	Evaluation of antigen-specific T cell populations	Evaluation of antigen-specific T cell frequency towards CMV, EBV and influenza virus by MHC tetramers	1 year	No
Secondary	Evaluation of antigen-specific T lymphocyte's functionality	antigen-specific T lymphocyte's functionality towards tumor cell line evaluated using a degranulation assay	1 year	No
Secondary	Evaluation of cytokines production by IL-2 and anti-CD16 activated NK cells		1 year	No