Allogeneic Stem Cell TransplantationPhase 3CONVINCENCT01185223
Study Comparing Valganciclovir Versus Ganciclovir in Patients Following Allogeneic Stem Cell Transplantation
A Phase 3 study testing Valganciclovir and Ganciclovir in people with Allogeneic Stem Cell Transplantation, run by Pierrel Research Europe GmbH at 17 sites in 3 countries.
Trial summary
The objective of this study is to assess the efficacy and safety of oral valganciclovir versus intravenous ganciclovir in patients following allogenic stem cell transplantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Allogeneic Stem Cell Transplantation
- What is being tested?
- Valganciclovir and Ganciclovir
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 17 sitesin 3 countries
- Study dates
- Sep 2010to Dec 2012
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient following allogeneic SCT
- Patient with a first episode of positive CMV-PCR (DNAemia) or pp65 antigenemia assay (antigenemia) up to 100 days after SCT
- Absolute neutrophil count (ANC) ≥1000 cells/µL on 2 consecutive follow-ups within 10 days before randomization
- Patient has a creatinine clearance of ≥25 mL/min (calculated by the Cockcroft-Gault formula, see Part I Section 6.1.2) with evidence of improving renal function,
- None or gastrointestinal graft-versus-host disease (GVHD) up to grade 2
Who cannot join
- Patient has a suspected or diagnosed CMV disease
- Patient has received syngeneic SCT
- Patient who received an investigational medicinal product (IMP) within the last 30 days prior to screening or who is simultaneously participating in another clinical study with an IMP
- Patient with a body weight <50 kg or >95 kg,
- Patient has received anti-CMV therapy within the past 30 days prior to screening (the use of acyclovir, valacyclovir, or famciclovir is permitted)
- Patient who has participated in this study before,
Show all 10Show fewer
- Patient who shows a neutropenia, thrombocytopenia, or anemia within 10 days before or at the time point of randomization as following:
- The ANC is <1000 cells/μL on 2 consecutive follow-ups, or
- A platelet count of ≥25000/μL can not be achieved/maintained with platelet transfusions
- A hemoglobin level of ≥8g/dL can not be achieved/maintained by red blood cell transfusions
Trial locations and contacts
17 sites in 3 countries.
17 sites in 3 countries
Germany10 sites
Pierrel Site 12
Berlin
Pierrel Site 13
Berlin
Pierrel Site 9
Bremen
Pierrel Site 3
Essen
Pierrel Site 7
Kiel
Pierrel Site 5
Leipzig
Pierrel Site 4
Münster
Pierrel Site 8
Oldenburg
Pierrel Site 10
Rostock
Pierrel Site 1
Würzburg
Spain6 sites
Pierrel Site 32
Barcelona
Pierrel Site33
Barcelona
Pierrel Site 30
Madrid
Pierrel Site 34
Madrid
Pierrel Site 31
Salamanca
Pierrel Site 35
Valencia
About this study
Official title: Multicenter, Randomized Study Comparing Oral Valganciclovir Versus Intravenous Ganciclovir in Patients Following Allogeneic Stem Cell Transplantation
The objective of this study is to assess the efficacy and safety of oral valganciclovir versus intravenous ganciclovir in patients following allogenic stem cell transplantation.
- Conditions
- Allogeneic Stem Cell Transplantation
- Being tested
- Valganciclovir, Ganciclovir
- Keywords
- Valganciclovir, Ganciclovir, Antiviral Drug, CMV disease
- Medical subject headings
- Multiple Acyl Coenzyme A Dehydrogenase Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ValganciclovirDrug
Also called Ro 107-9070, Valcyte
Valganciclovir 450mg tablet or Valganciclovir powder for oral solution 50mg/mL
GanciclovirDrug
Also called Cymeven
2x5mg/kg/d intravenous ganciclovir
| Study group | Role | What they receive |
|---|---|---|
| Valganciclovir | Other | Not described Receives: Drug: Valganciclovir |
| Ganciclovir | Active comparator | Not described Receives: Drug: Ganciclovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy and Safety of oral valganciclovir versus intravenous ganciclovir
Main variable for efficacy in the primary endpoint will be evaluated by assessment of the event-free survival within 180 days after stem cell transplantation.
Main variable for safety in the primary endpoint will be evaluated by the porpotion of patients with severe neutropenia until 7 days after discontinuation of antiviral therapy with the study drug.
Measured: max. 2 years (recruitement time)
Secondary outcomes (1)
Combined secondary endpoint of efficacy and safety
The secondary variables of efficacy will be:
The proportion of patients with persistently positive blood specimens for CMV after completion of antiviral therapy with the Study Drug,
- The proportion of patients who require retreatment after discontinuation of antiviral therapy with the Study Drug until day 180,
- The proportion of patients with CMV disease within 180 days after SCT,
- The number of days patients were alive and not hospitalized between randomization and day 180 post SCT,
- The proportion of patients who died from any cause within 180 days after SCT.
Measured: max. 2 years (recruitement time)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2010 (estimated)
- Study startSep 2010
- Primary completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allogeneic Stem Cell TransplantationStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 212 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pierrel Research Europe GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Roche Pharma AG
- Investigators
- Hermann Einsele, Prof. Dr., Principal investigator, Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01185223
- Sponsor's protocol ID
- ML 22371
- Acronym
- CONVINCE
- Status last verified
- Dec 2012
- First submitted
- 18 Aug 2010
- Last updated
- 10 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized Study Comparing Oral Valganciclovir Versus Intravenous Ganciclovir in Patients Following Allogeneic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT01185223
- Acronym / sponsor ID
- CONVINCE / ML 22371
- Conditions
- Allogeneic Stem Cell Transplantation
- Keywords
- Valganciclovir, Ganciclovir, Antiviral Drug, CMV disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 212 participants (estimated)
- Lead sponsor
- Pierrel Research Europe GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Roche Pharma AG
- Study start
- Sep 2010
- Primary completion
- Dec 2012 (estimated)
- First posted
- 19 Aug 2010 (estimated)
- 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.
The objective of this study is to assess the efficacy and safety of oral valganciclovir versus intravenous ganciclovir in patients following allogenic stem cell transplantation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Valganciclovir | Other | Drug: Valganciclovir |
| Ganciclovir | Active comparator | Drug: Ganciclovir |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient following allogeneic SCT
- Patient with a first episode of positive CMV-PCR (DNAemia) or pp65 antigenemia assay (antigenemia) up to 100 days after SCT
- Absolute neutrophil count (ANC) ≥1000 cells/µL on 2 consecutive follow-ups within 10 days before randomization
- Patient has a creatinine clearance of ≥25 mL/min (calculated by the Cockcroft-Gault formula, see Part I Section 6.1.2) with evidence of improving renal function,
- None or gastrointestinal graft-versus-host disease (GVHD) up to grade 2
Key exclusion criteria (10 listed)
- Patient has a suspected or diagnosed CMV disease
- Patient has received syngeneic SCT
- Patient who received an investigational medicinal product (IMP) within the last 30 days prior to screening or who is simultaneously participating in another clinical study with an IMP
- Patient with a body weight <50 kg or >95 kg,
- Patient has received anti-CMV therapy within the past 30 days prior to screening (the use of acyclovir, valacyclovir, or famciclovir is permitted)
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 |
|---|---|---|
| ValganciclovirAlso: Ro 107-9070, ValcyteValganciclovir 450mg tablet or Valganciclovir powder for oral solution 50mg/mL | Drug | Valganciclovir |
| GanciclovirAlso: Cymeven2x5mg/kg/d intravenous ganciclovir | Drug | Ganciclovir |
Primary outcome
Efficacy and Safety of oral valganciclovir versus intravenous ganciclovir
Time frame: max. 2 years (recruitement time)
Main variable for efficacy in the primary endpoint will be evaluated by assessment of the event-free survival within 180 days after stem cell transplantation. Main variable for safety in the primary endpoint will be evaluated by the porpotion of patients with severe neutropenia until 7 days after discontinuation of antiviral therapy with the study drug.
1 secondary outcome
Combined secondary endpoint of efficacy and safety
Time frame: max. 2 years (recruitement time)
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2012.
Related trials for Allogeneic Stem Cell Transplantation
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RecruitingObservational study
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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.
Hermann Einsele, Prof. Dr. principal investigator
Hospital
17 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Valganciclovir and Ganciclovir in people with Allogeneic Stem Cell Transplantation, run by Pierrel Research Europe GmbH at 17 sites in 3 countries.
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 5 inclusion and 10 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: stopped early, as of the sponsor's last update on 10 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Germany, Spain, Austria. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early. Results are not available in the source record.
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?
Efficacy and Safety of oral valganciclovir versus intravenous ganciclovir (time frame: max. 2 years (recruitement time)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Dec 2012.