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Trial record 90 of 112 for:    acyclovir

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

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ClinicalTrials.gov Identifier: NCT03159845
Recruitment Status : Suspended (reached the first step of recruitment. Waiting for amendment)
First Posted : May 19, 2017
Last Update Posted : January 10, 2019
Sponsor:
Information provided by (Responsible Party):
Lorenzo Iovino, 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.

Condition or disease Intervention/treatment Phase
Stem Cell Transplant Complications Drug: Zinc Sulfate Oral Product Drug: Levofloxacin 500Mg Oral Tablet Drug: Fluconazole 200mg tab Drug: Acyclovir 400 MG Phase 2

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Case-control study, open, without placebo
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Actual Study Start Date : January 1, 2014
Estimated Primary Completion Date : January 9, 2019
Estimated Study Completion Date : January 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Control
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
Drug: Levofloxacin 500Mg Oral Tablet
once daily from day +10 until day +30 after stem cell transplantation

Drug: Fluconazole 200mg tab
twice daily from day +10 until day +30 after stem cell transplantation

Drug: Acyclovir 400 MG
twice daily from day +10 until day +30 after stem cell transplantation

Experimental: Zinc
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
Drug: Zinc Sulfate Oral Product
Drug: Levofloxacin 500Mg Oral Tablet
once daily from day +10 until day +30 after stem cell transplantation

Drug: Fluconazole 200mg tab
twice daily from day +10 until day +30 after stem cell transplantation

Drug: Acyclovir 400 MG
twice daily from day +10 until day +30 after stem cell transplantation




Primary Outcome Measures :
  1. Thymic output improvement by TRECs [ Time Frame: 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

  2. Thymic output improvement by flow cytometry [ Time Frame: 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


Secondary Outcome Measures :
  1. Variations in circulating lymphocyte populations [ Time Frame: days +30, +100 after transplant ]
    Flow cytometry to determine the variations of t cell subpopulations after graft

  2. Immune competence [ Time Frame: days +30, +100 after transplant ]
    quantitative polymerase chain reaction on peripheral blood aiming to quantify Torquetenovirus viral load

  3. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: days +30, +100 after transplant ]
    case report form to report side effects



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03159845


Locations
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Italy
Hematology UO
Pisa, Italy, 56126
Sponsors and Collaborators
Azienda Ospedaliero, Universitaria Pisana

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Lorenzo Iovino, MD, Azienda Ospedaliero, Universitaria Pisana
ClinicalTrials.gov Identifier: NCT03159845     History of Changes
Other Study ID Numbers: Hematology AOUPisa
First Posted: May 19, 2017    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Lorenzo Iovino, Azienda Ospedaliero, Universitaria Pisana:
zinc

Additional relevant MeSH terms:
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Acyclovir
Zinc
Levofloxacin
Ofloxacin
Fluconazole
Zinc Sulfate
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Anti-Bacterial Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Antifungal Agents
14-alpha Demethylase Inhibitors
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors
Antiviral Agents