Zinc as Enhancer in Immune Recovery After Stem Cell Transplantation for Hematological Malignancies

Stem Cell Transplant Complications Clinical Trial

— ZENITH  

Official title:

A Mono-centric, No-profit, Case-control Study With Daily Oral Supplementation of Zinc Sulphate After Autologous Stem Cell Transplantation in Patients Affected by Multiple Myeloma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03159845
• Other study ID #: Hematology AOUPisa
• Status: Completed
• Phase: Phase 2
• Start date: January 1, 2014
• Est. completion date: September 10, 2019

Study information

• Verified date: January 2020
• Source: Azienda Ospedaliero, Universitaria Pisana
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patients affected by multiple myeloma undergone autologous stem cell transplantation (SCT) are enrolled at the moment of stem cell collection. They are randomized 1:1 in two groups at the moment of the graft. Patients of the Control group take only standard antimicrobial prophylaxis after SCT; the Sample group takes in addition a daily oral supplementation of Zinc Sulfate (600 mg/die) from day +5 until day +100 after SCT. Laboratory tests are performed on peripheral blood samples.

Description:

Patients affected by multiple myeloma undergone autologous stem cell transplantation (SCT) are enrolled at the moment of stem cell collection. They are randomized 1:1 in two groups at the moment of the graft. Patients of the Control group take only standard antimicrobial prophylaxis after SCT; the Sample group takes in addition a daily oral supplementation of Zinc Sulfate (600 mg/die) from day +5 until day +100 after SCT. The aim of the study is to investigate the immune reconstitution in presence of Zinc, focused on thymic reconstitution. Laboratory tests are performed on peripheral blood samples, collected at 4 time-points: two before transplant (at the moment of the enrollment and the day before conditioning) and two after transplant (day +30 and +100).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 10, 2019
• Est. primary completion date: September 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• eligibility to stem cell transplantation

Exclusion Criteria:

• allergy to Zinc

• copper deficiency or Wilson's syndrome

• patients who admit zinc assumption in other drugs

Related Conditions & MeSH terms

• Stem Cell Transplant Complications

Intervention

Drug:
• Zinc Sulfate Oral Product

• Levofloxacin 500Mg Oral Tablet
once daily from day +10 until day +30 after stem cell transplantation
• Fluconazole 200mg tab
twice daily from day +10 until day +30 after stem cell transplantation
• Acyclovir 400 MG
twice daily from day +10 until day +30 after stem cell transplantation

Locations

Country	Name	City	State
Italy	Hematology UO	Pisa

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliero, Universitaria Pisana

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Thymic output improvement by TRECs	Measure of T cell receptor excision circles levels on peripheral lymphocytes (TRECs), calculated as number of copies of TRECs/mcLin droplet digital PCR	increase of TRECs levels from day +30 until day +100 after transplant
Primary	Thymic output improvement by flow cytometry	Measure of circulating T naive lymphocytes by 8-colour flow-cytometry. T naive are identified as CD4+/CD8+ lymphocytes with the coexpression of CD45RA, CD27, CD28. The value is estimated as number of T naive/mcL	days +30, +100 after transplant
Secondary	Variations in circulating lymphocyte populations	Flow cytometry to determine the variations of t cell subpopulations after graft	days +30, +100 after transplant
Secondary	Immune competence	quantitative polymerase chain reaction on peripheral blood aiming to quantify Torquetenovirus viral load	days +30, +100 after transplant
Secondary	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	case report form to report side effects	days +30, +100 after transplant