Safety and EfficacyPhase 4NCT04446806
Prevention and Treatment of Differentiation Syndrome in Patients With Acute Promyelocytic Leukemia
A Phase 4 study testing Ruxolitinib in people with Safety and Efficacy, run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
With the introduction of all-trans-retinoic acid (ATRA) and arsenic,the outcome of patients with acute promyelocytic leukemia (APL)has been improved considerably over the last decades.However，early deaths (EDs), mainly due to APL-specific coagulopathy, differentiation syndrome (DS)emerge as a major threat to APL… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Safety and Efficacy
- What is being tested?
- Ruxolitinib
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2019to 31 May 2021
- Phase
- Phase 4
- 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
- Clinical diagnosis of primary acute promyelocytic leukemia.
- ECOG score≤3.
- Must be able to understand and willing to participate in the study and sign the informed consent.
Who cannot join
- Refractory/secondary acute promyelocytic leukemia.
- Severe complications such as myocardial infarction, chronic cardiac insufficiency, hepatic failure, renal insufficiency, etc.
- Clinically uncontrolled active infections.
- Malignant tumors with other progresses.
- Ecg: QT interval > 450 ms.
- Allergic to arsenic agent.
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital, Soochow University
Suzhou, Jiangsu, 215000
Qian Wu, 8613656205608, 42732890@qq.com
About this study
Official title: A Prospective Single Center Study of Prevention and Treatment of Differentiation Syndrome in Patients With Acute Promyelocytic Leukemia
With the introduction of all-trans-retinoic acid (ATRA) and arsenic,the outcome of patients with acute promyelocytic leukemia (APL)has been improved considerably over the last decades.However，early deaths (EDs), mainly due to APL-specific coagulopathy, differentiation syndrome (DS)emerge as a major threat to APL patients.We observe and evaluate the effectivity of induction therapy in patients with APL. Administrate intravenous dexamethasone to prevent or preemptive treat DS. Assess the efficacy and safety of ruxolitinib as second treatment in patients with severe DS with no respond to dexamethasone.Furthermore，the changes of spectrum of cytokines are monitered to find the relationship between the cytokines and the severity of DS.
Read the detailed description
Adults ages 18-75 with primary acute promyelocytic leukemia.
Design:
The induction therapy with ATRA 25mg/m2/d and ATO 10mg/kg/d should be started as soon as the diagnosis of APL confirmed.
Intravenous dexamethasone at a dose of 5-20 mg daily must be started if the WBC count greater than 5e+9/L (before or during the treatment with ATRA) as prevention or preemptive therapy of DS.
Idarubicin (4-10 mg/m2 /d*3d) and hydroxyurea（1.0-3.0g/d）can be given as leukocyte lowering therapy which may lessen the risk of DS.
When the progression of clinical symptoms of DS with no response to dexamethasone,ATRA must be stopped and ruxolitinib (5-20mg /d) should be administrated to reduce the production of cytokines.
Participants should stay in the hospital during the treatment for about 4 weeks.
The changes of spectrum of cytokines are monitored to discover the potential relationship between the cytokines and the severity of DS.
Participants will visit every 1 months after CR for 3 years.
- Conditions
- Safety and Efficacy
- Being tested
- Ruxolitinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RuxolitinibDrug
Ruxolitinib as second treatment in patients with severe DS failed in responding to hormone.Furthermore
What is being measured
The primary outcome is the main question the study is designed to answer.
complete remission rate
complete remission rate after treated by the induction regimen with ATRA and Arsenite
Measured: during the induction treatment
incidence and severity of differentiation syndrome
All symptoms and signs associated to DS should be paid closely attention to.
Measured: during the induction treatment
Secondary outcomes (1)
overall survival
from the date of inclusion to date of death, irrespective of cause
Measured: from the day of first patient treatment up to 36 months after the last patient's enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2020
- Study start1 Jun 2019
- Primary completion31 Dec 2020 (estimated)
- Study completion31 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety and EfficacyStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Soochow UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qian Wu, Study chair, First Affiliated Hospital, Soochow University Suzhou, Jiangsu, China, 215000
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04446806
- Sponsor's protocol ID
- APL-01
- Status last verified
- Mar 2020
- First submitted
- 29 Mar 2020
- Last updated
- 25 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Single Center Study of Prevention and Treatment of Differentiation Syndrome in Patients With Acute Promyelocytic Leukemia
- ClinicalTrials.gov ID
- NCT04446806
- Acronym / sponsor ID
- APL-01
- Conditions
- Safety and Efficacy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 May 2021 (estimated)
- First posted
- 25 Jun 2020 (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.
With the introduction of all-trans-retinoic acid (ATRA) and arsenic,the outcome of patients with acute promyelocytic leukemia (APL)has been improved considerably over the last decades.However，early deaths (EDs), mainly due to APL-specific coagulopathy, differentiation syndrome (DS)emerge as a major threat to APL patients.We observe and evaluate the effectivity of induction therapy in patients with APL. Administrate intravenous dexamethasone to prevent or preemptive treat DS. Assess the efficacy and safety of ruxolitinib as second treatment in patients with severe DS with no respond to dexamethasone.Furthermore，the changes of spectrum of cytokines are monitered to find the relationship between the cytokines and the severity of DS.
Detailed description
Adults ages 18-75 with primary acute promyelocytic leukemia.
Design:
The induction therapy with ATRA 25mg/m2/d and ATO 10mg/kg/d should be started as soon as the diagnosis of APL confirmed.
Intravenous dexamethasone at a dose of 5-20 mg daily must be started if the WBC count greater than 5e+9/L (before or during the treatment with ATRA) as prevention or preemptive therapy of DS.
Idarubicin (4-10 mg/m2 /d*3d) and hydroxyurea（1.0-3.0g/d）can be given as leukocyte lowering therapy which may lessen the risk of DS.
When the progression of clinical symptoms of DS with no response to dexamethasone,ATRA must be stopped and ruxolitinib (5-20mg /d) should be administrated to reduce the production of cytokines.
Participants should stay in the hospital during the treatment for about 4 weeks.
The changes of spectrum of cytokines are monitored to discover the potential relationship between the cytokines and the severity of DS.
Participants will visit every 1 months after CR for 3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of primary acute promyelocytic leukemia.
- ECOG score≤3.
- Must be able to understand and willing to participate in the study and sign the informed consent.
Key exclusion criteria (7 listed)
- Refractory/secondary acute promyelocytic leukemia.
- Severe complications such as myocardial infarction, chronic cardiac insufficiency, hepatic failure, renal insufficiency, etc.
- Clinically uncontrolled active infections.
- Malignant tumors with other progresses.
- Ecg: QT interval > 450 ms.
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 |
|---|---|---|
| RuxolitinibRuxolitinib as second treatment in patients with severe DS failed in responding to hormone.Furthermore | Drug | – |
Primary outcome
complete remission rate
Time frame: during the induction treatment
complete remission rate after treated by the induction regimen with ATRA and Arsenite
incidence and severity of differentiation syndrome
Time frame: during the induction treatment
All symptoms and signs associated to DS should be paid closely attention to.
1 secondary outcome
overall survival
Time frame: from the day of first patient treatment up to 36 months after the last patient's enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2020.
- 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.
Qian Wu study chair
First Affiliated Hospital, Soochow University Suzhou, Jiangsu, China, 215000
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ruxolitinib in people with Safety and Efficacy, run by The First Affiliated Hospital of Soochow University at 1 site in China.
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 3 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: status not confirmed, as of the sponsor's last update on 25 Jun 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 China. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Suning Chen (8613814881746, chensuning@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complete remission rate (time frame: during the induction treatment). 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?
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 25 Jun 2020.