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New treatment option for Acute Promyelocytic Leukemia
Official title Treatment Study for Children and Adolescents With Acute Promyelocytic Leukemia
ClinicalTrials.gov ID: NCT04793919
What this study is testing
What is Mylotarg?
Mylotarg is an investigational medicine, being studied as a potential treatment for acute promyelocytic leukemia.
Also referred to as GO.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The trial is open to all patients with a diagnosis of acute promyelocytic leukemia (APL) who are PCR-positive for the PML-RARα transcript and less than 18 years of age.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 18
You may be able to join if
- Newly diagnosed APL confirmed by the presence of PML/RARα fusion gene
- Age \<18 years
- Written informed consent by parents or legal guardians
You likely can't join if
- Patients with a clinical diagnosis of APL but subsequently found to lack PML/RARα rearrangement should be withdrawn from the study and treated on an...
- Significant liver dysfunction (bilirubin serum levels \>3 mg/dL, ALT/AST serum levels greater than 5 times the normal values)
- Creatinine serum levels \>2 times the normal value for age
- Significant arrhythmias, EKG abnormalities (\ see below), other cardiac contraindications (L-FEV \<50% or LV-FS \<28%)
- Neuropathy
- Concurrent active malignancy
See the full eligibility criteria
- Newly diagnosed APL confirmed by the presence of PML/RARα fusion gene
- Age \<18 years
- Written informed consent by parents or legal guardians
- Patients with a clinical diagnosis of APL but subsequently found to lack PML/RARα rearrangement should be withdrawn from the study and treated on an alternative protocol
- Significant liver dysfunction (bilirubin serum levels \>3 mg/dL, ALT/AST serum levels greater than 5 times the normal values)
- Creatinine serum levels \>2 times the normal value for age
- Significant arrhythmias, EKG abnormalities (\ see below), other cardiac contraindications (L-FEV \<50% or LV-FS \<28%)
- Neuropathy
- Concurrent active malignancy
- Uncontrolled life-threatening infections
- Pregnant or lactating female
- Patients who had received alternative therapy (APL not initially suspected; ATRA and/or ATO not available
The study team makes the final eligibility decision.
Where it's taking place
- Brussels, Belgium
- Prague, Czechia
- Aarhus N, Denmark
- Bordeaux, France
- Essen, Germany
- Dublin, Ireland
- Haifa, Israel
- San Giovanni Rotondo, Foggia, Italy
- Bari, Italy
- Bergamo, Italy
- Bologna, Italy
- Cagliari, Italy
- Catania, Italy
- Florence, Italy
- Genova, Italy
- Monza, Italy
- Naples, Italy
- Padova, Italy
- Palermo, Italy
- Pavia, Italy
+ 9 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, up to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brussels, Belgium; Prague, Czechia; Aarhus N, Denmark; Bordeaux, France; Essen, Germany; Dublin, Ireland and 23 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.