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

Phase 2

Completed

• Conditions: Stem Cell Transplant Complications
• Interventions: Drug: Levofloxacin 500Mg Oral Tablet; Drug: Zinc Sulfate Oral Product; Drug: Fluconazole 200mg tab; Drug: Acyclovir 400 MG

• Registration Number: NCT03159845
• Lead Sponsor: Azienda Ospedaliero, Universitaria Pisana

Brief 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.

Detailed 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).

Study Timeline

• Study Start: 2014-01-01
• Study First Submitted: 2017-05-15
• Study First Submitted QC: 2017-05-18
• Study First Posted: 2017-05-19
• Primary Completion: 2019-09-10
• Study Completion: 2019-09-10
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-06
• Last Update Posted: 2020-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Levofloxacin 500Mg Oral Tablet	patients undergone autologous stem cell transplantation. They take levofloxacin 500 mg/d, aciclovir 400 mg bid, fluconazole 200 mg bid from day +10 until day +30 after stem cell transplantation
Zinc	Levofloxacin 500Mg Oral Tablet	patients undergone autologous stem cell transplantation. They take the same antimicrobial prophylaxis of patients of the Control group, and, in addition, a daily oral supplementation of Zinc Sulfate, 600 mg/die, uncoated tabs, from day +5 until day +100 after transplant
Zinc	Fluconazole 200mg tab	patients undergone autologous stem cell transplantation. They take the same antimicrobial prophylaxis of patients of the Control group, and, in addition, a daily oral supplementation of Zinc Sulfate, 600 mg/die, uncoated tabs, from day +5 until day +100 after transplant
Zinc	Acyclovir 400 MG	patients undergone autologous stem cell transplantation. They take the same antimicrobial prophylaxis of patients of the Control group, and, in addition, a daily oral supplementation of Zinc Sulfate, 600 mg/die, uncoated tabs, from day +5 until day +100 after transplant
Zinc	Zinc Sulfate Oral Product	patients undergone autologous stem cell transplantation. They take the same antimicrobial prophylaxis of patients of the Control group, and, in addition, a daily oral supplementation of Zinc Sulfate, 600 mg/die, uncoated tabs, from day +5 until day +100 after transplant
Control	Fluconazole 200mg tab	patients undergone autologous stem cell transplantation. They take levofloxacin 500 mg/d, aciclovir 400 mg bid, fluconazole 200 mg bid from day +10 until day +30 after stem cell transplantation
Control	Acyclovir 400 MG	patients undergone autologous stem cell transplantation. They take levofloxacin 500 mg/d, aciclovir 400 mg bid, fluconazole 200 mg bid from day +10 until day +30 after stem cell transplantation

Primary Outcome Measures

Name	Time	Method
Thymic output improvement by flow cytometry	days +30, +100 after transplant	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
Thymic output improvement by TRECs	increase of TRECs levels from day +30 until day +100 after transplant	Measure of T cell receptor excision circles levels on peripheral lymphocytes (TRECs), calculated as number of copies of TRECs/mcLin droplet digital PCR

Secondary Outcome Measures

Name	Time	Method
Variations in circulating lymphocyte populations	days +30, +100 after transplant	Flow cytometry to determine the variations of t cell subpopulations after graft
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	days +30, +100 after transplant	case report form to report side effects
Immune competence	days +30, +100 after transplant	quantitative polymerase chain reaction on peripheral blood aiming to quantify Torquetenovirus viral load

Trial Locations

Locations (1)

Hematology UO; 🇮🇹 Pisa, Italy