Patients Who Have Received Allo-HSCTPhase 2NCT03343600
Imatinib for Cytomegalovirus Prophylaxis and Treatment After Allogeneic Hematopoietic Stem Cell Transplantation
A Phase 2 study testing Imatinib in people with Patients Who Have Received Allo-HSCT, run by National Taiwan University Hospital at 5 sites in Taiwan.
Trial summary
This study aim at examining whether blocking platelet-derived growth factor receptor-α by imatinib lowers the risk of post-allogeneic hematopoietic stem cell transplantation CMV infection. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Patients Who Have Received Allo-HSCT
- What is being tested?
- Imatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 5 sitesTaiwan
- Study dates
- 9 Nov 2017to 31 Aug 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (Age ≧ 20) who received the first allo-HSCT are eligible;
- Patients with underlying disease of acute leukemia in morphological remission, or myelodysplastic syndrome;
- Received allo-HSCT with HLA-matched sibling or unrelated donors (at least 8/8 match for HLA-A/B/C/DR);
- Evidence of post-transplantation neutrophil engraftment: absolute neutrophil count > 500/mm3 for at least 3 consecutive days;
- No detectable CMV infection before study enrollment: negative plasma CMV DNA surveillance within passing 2 weeks;
- No previous post-transplantation anti-CMV therapy and no planned prophylactic anti-CMV therapy;
- The patients has the ability to swallow tablets
Who cannot join
- They have renal insufficiency: serum creatinine > 2.5 mg/dL;
- They have hepatic dysfunction: serum alanine or aspartate aminotransferase levels of > 5 times the upper limit of the normal range or a serum total bilirubin of > 3 mg/dL;
- Patients with history of HIV infection;
- Unstable post-BMT condition or other medical condition deemed not appropriate to be included to this study as judged by investigator;
- Life expectancy less than 3 months;
- Unwillingness or unable to give consent;
- Patients with diseases that are positive for t(9;22) or BCR-ABL fusion gene.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Taiwan5 sites
Tzu Chi General Hospital
Hualien City
Far Eastern Memorial Hospital
New Taipei City
National Cheng Kung Hospital
Tainan
National Taiwan University Hospital
Taipei
Tri-Service General Hospital
Taipei
About this study
Official title: A Randomization, Double Blind, Multicenter Phase II Clinical Trial to Evaluate the Imatinib for Prophylaxis of CMV Infection After Allogeneic Hematopoietic Stem Cell Transplantation
This study aim at examining whether blocking platelet-derived growth factor receptor-α by imatinib lowers the risk of post-allogeneic hematopoietic stem cell transplantation CMV infection.
Read the detailed description
This is a randomized, double-blind, multicenter phase II clinical trial. In the trial, post-allo-HSCT patients with signs of bone marrow engraftment and without evidence of CMV reactivation will be enrolled. All enrolled patients will be monitored for their blood CMV DNA copy numbers by Q-PCR and safety throughout the trial. In addition to their routine post-allo-HSCT care, eligible patients will receive imatinib (100mg/tablet, 2 tablets daily) or placebo (2 tablets daily) administration after myeloid engraftment (defined as absolute neutrophil count higher than 500 for three consecutive days). While receiving the trial therapy, patients will have a regular CMV surveillance every week by the quantification of plasma CMV DNA copies. During the administration of the investigational drugs, other concomitant anti-CMV prophylaxis treatments are prohibited. When a patient has any signs suggesting CMV infection that the treating physician determines that an anti-CMV therapy is indicated, the patient will be defined as failure of prophylaxis for the efficacy evaluation. Whether the conventional anti-CMV therapy is started or not, the investigational drugs with imatinib or placebo will be continued till at least Day+100 unless the patient is defined as prophylaxis failure or withdraws from the study including personal reasons, early mortality, disease recurrence after transplantation, pregnancy, or the investigator decides that the subject should be withdrawn for safety reasons or physical conditions.
- Conditions
- Patients Who Have Received Allo-HSCT
- Being tested
- Imatinib, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImatinibDrug
Imatinib 100 mg/tablet, 2 tablets daily
PlaceboDrug
Placebos 2 tablets daily
| Study group | Role | What they receive |
|---|---|---|
| Imatinib | Experimental | Imatinib (100 mg/tablet) 2# per day till D+100 after allo-HSCT or prophylaxis failure. Receives: Drug: Imatinib |
| Placebo | Placebo comparator | Placebo 2# per day till D+100 after allo-HSCT or prophylaxis failure. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants free from initiating conventional anti-CMV treatment by Day+100 after allo-HSCT.
Investigator determined whether anti-CMV treatment is needed or not based on clinical judgment no matter therapeutic or preemptive treatment. Symptomatic CMV infection or CMV organ disease was defined as described by Ljungman et al., 2002.
Measured: From first dosing to 100 days after allo-HSCT (Day+100)
Secondary outcomes (5)
Number of treatment-related adverse events (AE) by Day+100 after allo-HSCT.
Safety profile will be evaluated according to treatment-related adverse events (AE) per CTCAE 4.03 version.
Measured: From first dosing to 100 days after allo-HSCT (Day+100)
Time to onset of CMV reactivation defined by peripheral blood CMV copies by Day+100 after allo-HSCT.
The peripheral blood CMV DNA copy numbers (copies/mL) were determined using a commercial kit with PCR method following its protocol. The CMV copy numbers are monitored on a weekly basis.
Measured: From first dosing to 100 days after allo-HSCT (Day+100)
Time to onset of CMV disease diagnosed by investigator by Day+100 after allo-HSCT.
The diagnosis of CMV disease is based on clinical practice and the invasive procedure was encouraged to make the definite diagnosis. The reference to CMV organ disease definition was described by Ljungman et al., 2002.
Measured: From first dosing to 100 days after allo-HSCT (Day+100)
Number of participants who had progressive hematological disease within 6 months after allo-HSCT.
Defined as any subject that is known to have a progressive hematological disease.
Measured: 6 months post-transplant
Number of participants who died within 6 months after allo-HSCT.
Defined as any subject that is known to be dead.
Measured: 6 months post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start9 Nov 2017
- Primary completion31 Aug 2019
- Study completion31 Aug 2019
Why it stopped: The trial is terminated due to the extremely low recruitment rate.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Who Have Received Allo-HSCTStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Far Eastern Memorial Hospital, Tri-Service General Hospital (TSGH), National Cheng-Kung University Hospital, Hualien Tzu Chi General Hospital
- Responsible party
- Sponsor
- Investigators
- Chien-Ting Lin, MD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03343600
- Sponsor's protocol ID
- 201707076MIPB
- Status last verified
- Sep 2019
- First submitted
- 27 Sep 2017
- Last updated
- 11 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomization, Double Blind, Multicenter Phase II Clinical Trial to Evaluate the Imatinib for Prophylaxis of CMV Infection After Allogeneic Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT03343600
- Acronym / sponsor ID
- 201707076MIPB
- Conditions
- Patients Who Have Received Allo-HSCT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The trial is terminated due to the extremely low recruitment rate.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- Far Eastern Memorial Hospital, Tri-Service General Hospital (TSGH), National Cheng-Kung University Hospital, Hualien Tzu Chi General Hospital
- Study start
- 9 Nov 2017 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 17 Nov 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.
This study aim at examining whether blocking platelet-derived growth factor receptor-α by imatinib lowers the risk of post-allogeneic hematopoietic stem cell transplantation CMV infection.
Detailed description
This is a randomized, double-blind, multicenter phase II clinical trial. In the trial, post-allo-HSCT patients with signs of bone marrow engraftment and without evidence of CMV reactivation will be enrolled. All enrolled patients will be monitored for their blood CMV DNA copy numbers by Q-PCR and safety throughout the trial. In addition to their routine post-allo-HSCT care, eligible patients will receive imatinib (100mg/tablet, 2 tablets daily) or placebo (2 tablets daily) administration after myeloid engraftment (defined as absolute neutrophil count higher than 500 for three consecutive days). While receiving the trial therapy, patients will have a regular CMV surveillance every week by the quantification of plasma CMV DNA copies. During the administration of the investigational drugs, other concomitant anti-CMV prophylaxis treatments are prohibited. When a patient has any signs suggesting CMV infection that the treating physician determines that an anti-CMV therapy is indicated, the patient will be defined as failure of prophylaxis for the efficacy evaluation. Whether the conventional anti-CMV therapy is started or not, the investigational drugs with imatinib or placebo will be continued till at least Day+100 unless the patient is defined as prophylaxis failure or withdraws from the study including personal reasons, early mortality, disease recurrence after transplantation, pregnancy, or the investigator decides that the subject should be withdrawn for safety reasons or physical conditions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Imatinib | Experimental | Drug: ImatinibImatinib (100 mg/tablet) 2# per day till D+100 after allo-HSCT or prophylaxis failure. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo 2# per day till D+100 after allo-HSCT or prophylaxis failure. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult patients (Age ≧ 20) who received the first allo-HSCT are eligible;
- Patients with underlying disease of acute leukemia in morphological remission, or myelodysplastic syndrome;
- Received allo-HSCT with HLA-matched sibling or unrelated donors (at least 8/8 match for HLA-A/B/C/DR);
- Evidence of post-transplantation neutrophil engraftment: absolute neutrophil count > 500/mm3 for at least 3 consecutive days;
- No detectable CMV infection before study enrollment: negative plasma CMV DNA surveillance within passing 2 weeks;
Key exclusion criteria (7 listed)
- They have renal insufficiency: serum creatinine > 2.5 mg/dL;
- They have hepatic dysfunction: serum alanine or aspartate aminotransferase levels of > 5 times the upper limit of the normal range or a serum total bilirubin of > 3 mg/dL;
- Patients with history of HIV infection;
- Unstable post-BMT condition or other medical condition deemed not appropriate to be included to this study as judged by investigator;
- Life expectancy less than 3 months;
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 |
|---|---|---|
| ImatinibImatinib 100 mg/tablet, 2 tablets daily | Drug | Imatinib |
| PlaceboPlacebos 2 tablets daily | Drug | Placebo |
Primary outcome
Number of participants free from initiating conventional anti-CMV treatment by Day+100 after allo-HSCT.
Time frame: From first dosing to 100 days after allo-HSCT (Day+100)
Investigator determined whether anti-CMV treatment is needed or not based on clinical judgment no matter therapeutic or preemptive treatment. Symptomatic CMV infection or CMV organ disease was defined as described by Ljungman et al., 2002.
5 secondary outcomes
Number of treatment-related adverse events (AE) by Day+100 after allo-HSCT.
Time frame: From first dosing to 100 days after allo-HSCT (Day+100)
Time to onset of CMV reactivation defined by peripheral blood CMV copies by Day+100 after allo-HSCT.
Time frame: From first dosing to 100 days after allo-HSCT (Day+100)
Time to onset of CMV disease diagnosed by investigator by Day+100 after allo-HSCT.
Time frame: From first dosing to 100 days after allo-HSCT (Day+100)
Number of participants who had progressive hematological disease within 6 months after allo-HSCT.
Time frame: 6 months post-transplant
Number of participants who died within 6 months after allo-HSCT.
Time frame: 6 months post-transplant
Results and safety
The study was stopped early (reason given: The trial is terminated due to the extremely low recruitment rate.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2019.
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.
Chien-Ting Lin, MD principal investigator
National Taiwan University Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Imatinib in people with Patients Who Have Received Allo-HSCT, run by National Taiwan University Hospital at 5 sites in Taiwan.
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 7 inclusion and 7 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 11 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Taiwan. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: The trial is terminated due to the extremely low recruitment rate.). 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?
Number of participants free from initiating conventional anti-CMV treatment by Day+100 after allo-HSCT. (time frame: From first dosing to 100 days after allo-HSCT (Day+100)). 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 11 Sep 2019.