Stem Cell Transplant ComplicationsPhase 2ZENITHNCT03159845
Zinc as Enhancer in Immune Recovery After Stem Cell Transplantation for Hematological Malignancies
A Phase 2 study testing Zinc Sulfate Oral Product, Levofloxacin 500Mg Oral Tablet and Fluconazole 200mg tab in people with Stem Cell Transplant Complications, run by Azienda Ospedaliero, Universitaria Pisana at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Stem Cell Transplant Complications
- What is being tested?
- Zinc Sulfate Oral Product, Levofloxacin 500Mg Oral Tablet and Fluconazole 200mg tab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2014to 10 Sep 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- eligibility to stem cell transplantation
Who cannot join
- allergy to Zinc
- copper deficiency or Wilson's syndrome
- patients who admit zinc assumption in other drugs
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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).
- Conditions
- Stem Cell Transplant Complications
- Being tested
- Zinc Sulfate Oral Product, Levofloxacin 500Mg Oral Tablet, Fluconazole 200mg tab, Acyclovir 400 MG
- Keywords
- zinc
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zinc Sulfate Oral ProductDrug
Levofloxacin 500Mg Oral TabletDrug
once daily from day +10 until day +30 after stem cell transplantation
Fluconazole 200mg tabDrug
twice daily from day +10 until day +30 after stem cell transplantation
Acyclovir 400 MGDrug
twice daily from day +10 until day +30 after stem cell transplantation
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | 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 Receives: Drug: Levofloxacin 500Mg Oral Tablet; Drug: Fluconazole 200mg tab; Drug: Acyclovir 400 MG |
| Zinc | Experimental | 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 Receives: Drug: Zinc Sulfate Oral Product; Drug: Levofloxacin 500Mg Oral Tablet; Drug: Fluconazole 200mg tab; Drug: Acyclovir 400 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: increase of TRECs levels from day +30 until day +100 after transplant
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
Measured: days +30, +100 after transplant
Secondary outcomes (3)
Variations in circulating lymphocyte populations
Flow cytometry to determine the variations of t cell subpopulations after graft
Measured: days +30, +100 after transplant
Immune competence
quantitative polymerase chain reaction on peripheral blood aiming to quantify Torquetenovirus viral load
Measured: days +30, +100 after transplant
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
case report form to report side effects
Measured: days +30, +100 after transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2017
- Study start1 Jan 2014
- Primary completion10 Sep 2019
- Study completion10 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stem Cell Transplant ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Case-control study, open, without placebo
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero, Universitaria Pisana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lorenzo Iovino, Azienda Ospedaliero, Universitaria Pisana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03159845
- Sponsor's protocol ID
- Hematology AOUPisa
- Acronym
- ZENITH
- Status last verified
- Jan 2020
- First submitted
- 15 May 2017
- Last updated
- 7 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Iovino L, Mazziotta F, Carulli G, Guerrini F, Morganti R, Mazzotti V, Maggi F, Macera L, Orciuolo E, Buda G, Benedetti E, Caracciolo F, Galimberti S, Pistello M, Petrini M. High-dose zinc oral supplementation after stem cell transplantation causes an increase of TRECs and CD4+ naive lymphocytes and prevents TTV reactivation. Leuk Res. 2018 Jul;70:20-24. doi: 10.1016/j.leukres.2018.04.016. Epub 2018 May 2.
PubMed 29747074
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03159845
- Acronym / sponsor ID
- ZENITH / Hematology AOUPisa
- Conditions
- Stem Cell Transplant Complications
- Keywords
- zinc
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero, Universitaria PisanaUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 10 Sep 2019 (actual)
- Study completion
- 10 Sep 2019 (actual)
- First posted
- 19 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Case-control study, open, without placebo
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Drug: Levofloxacin 500Mg Oral Tablet, Drug: Fluconazole 200mg tab, Drug: Acyclovir 400 MGpatients 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 | Experimental | Drug: Zinc Sulfate Oral Product, Drug: Levofloxacin 500Mg Oral Tablet, Drug: Fluconazole 200mg tab, Drug: Acyclovir 400 MGpatients 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- eligibility to stem cell transplantation
Key exclusion criteria (3 listed)
- allergy to Zinc
- copper deficiency or Wilson's syndrome
- patients who admit zinc assumption in other drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zinc Sulfate Oral Product | Drug | Zinc |
| Levofloxacin 500Mg Oral Tabletonce daily from day +10 until day +30 after stem cell transplantation | Drug | Control, Zinc |
| Fluconazole 200mg tabtwice daily from day +10 until day +30 after stem cell transplantation | Drug | Control, Zinc |
| Acyclovir 400 MGtwice daily from day +10 until day +30 after stem cell transplantation | Drug | Control, Zinc |
Primary outcome
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
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
3 secondary outcomes
Variations in circulating lymphocyte populations
Time frame: days +30, +100 after transplant
Immune competence
Time frame: days +30, +100 after transplant
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: days +30, +100 after transplant
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2020.
- Derived from this study: PubMed 29747074Iovino L, Mazziotta F, Carulli G, Guerrini F, Morganti R, Mazzotti V, Maggi F, Macera L, Orciuolo E, Buda G, Benedetti E, Caracciolo F, Galimberti S, Pistello M, Petrini M. High-dose zinc oral supplementation after stem cell transplantation causes an increase of TRECs and CD4+ naive lymphocytes and prevents TTV reactivation. Leuk Res. 2018 Jul;70:20-24. doi: 10.1016/j.leukres.2018.04.016. Epub 2018 May 2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Zinc Sulfate Oral Product, Levofloxacin 500Mg Oral Tablet and Fluconazole 200mg tab in people with Stem Cell Transplant Complications, run by Azienda Ospedaliero, Universitaria Pisana at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thymic output improvement by TRECs (time frame: increase of TRECs levels from day +30 until day +100 after transplant). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03159845, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2020.