APLPhase 4NCT02020161
Clinical Guidelines for APL Treatment
A Phase 4 study testing Atra, Idarubicin and methotrexate in people with APL, run by PETHEMA Foundation at 1 site in Spain.
Trial summary
Therapeutic guidelines for treatment of patients with de novo APL to be used by every institution that wants to follow them. All patients who are reported may be retrospectively analyzed Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- APL
- What is being tested?
- Atra, Idarubicin and methotrexate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2012to Dec 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Genetic diagnosis of acute promyelocytic leukemia
Who cannot join
- No exclusion criteria
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital La Fe
Valencia
Pau Montesinos, Dr, montesinos_pau@gva.es
About this study
Therapeutic guidelines for treatment of patients with de novo APL to be used by every institution that wants to follow them. All patients who are reported may be retrospectively analyzed
- Conditions
- APL
- Being tested
- Atra, Idarubicin, methotrexate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtraDrug
IdarubicinDrug
methotrexateDrug
| Study group | Role | What they receive |
|---|---|---|
| ATRA-Idarubicin | Experimental | Not described Receives: Drug: Atra; Drug: Idarubicin; Drug: methotrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence within 1 year of treatment
Induction therapy with simultaneous ATRA (45 mg/m2 day until CR) and idarubicin (12 mg/m2 day on days 2, 4, 6 and 8 or 12 mg/m2 day on days 2, 4 and 6 in patients older than or equal to 60 years).
Three monthly consolidation courses with ATRA Maintenance therapy with ATRA (45 mg/m2/d, days 1-15 every 3 months), and low dose chemotherapy with methotrexate (15 mg/m2/d, weekly) and 6-mercaptopurine (50 mg/m2/d) for two years.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2013 (estimated)
- Study startJun 2012
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for APLStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PETHEMA Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02020161
- Sponsor's protocol ID
- PETHEMA LPA2012
- Status last verified
- Mar 2021
- First submitted
- 26 Nov 2013
- Last updated
- 23 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Guidelines for APL Treatment
- ClinicalTrials.gov ID
- NCT02020161
- Acronym / sponsor ID
- PETHEMA LPA2012
- Conditions
- APL
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- PETHEMA FoundationUniversity, hospital or other
- Study start
- Jun 2012 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 24 Dec 2013 (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.
Therapeutic guidelines for treatment of patients with de novo APL to be used by every institution that wants to follow them. All patients who are reported may be retrospectively analyzed
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ATRA-Idarubicin | Experimental | Drug: Atra, Drug: Idarubicin, Drug: methotrexate |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Genetic diagnosis of acute promyelocytic leukemia
Key exclusion criteria (1 listed)
- No exclusion criteria
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 |
|---|---|---|
| Atra | Drug | ATRA-Idarubicin |
| Idarubicin | Drug | ATRA-Idarubicin |
| methotrexate | Drug | ATRA-Idarubicin |
Primary outcome
Recurrence within 1 year of treatment
Time frame: 3 years
Induction therapy with simultaneous ATRA (45 mg/m2 day until CR) and idarubicin (12 mg/m2 day on days 2, 4, 6 and 8 or 12 mg/m2 day on days 2, 4 and 6 in patients older than or equal to 60 years). Three monthly consolidation courses with ATRA Maintenance therapy with ATRA (45 mg/m2/d, days 1-15 every 3 months), and low dose chemotherapy with methotrexate (15 mg/m2/d, weekly) and 6-mercaptopurine (50 mg/m2/d) for two years.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2021.
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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.
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 Atra, Idarubicin and methotrexate in people with APL, run by PETHEMA Foundation at 1 site in Spain.
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 1 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 23 Mar 2021. 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 Spain. 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 Pau Montesinos, Dr (+34 96 1244000, montesinos_pau@gva.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence within 1 year of treatment (time frame: 3 years). 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 23 Mar 2021.