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New treatment option for Anaplastic Large Cell Lymphoma, ALK-Positive
Official title Brigatinib in Pediatric and Young Adult Patients With ALK+ ALCL, IMT or Other Solid Tumors
ClinicalTrials.gov ID: NCT04925609
What this study is testing
What is Brigatinib?
Brigatinib is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for anaplastic large cell lymphoma, alk-positive.
Also referred to as Alunbrig.
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
- This is an open-label, phase I-II dose-escalation and expansion study designed to define the recommended dose of brigatinib as monotherapy in pediatric and young adult patients with ALK+ ALCL, IMT or other solid tumors and to evaluate the pharmacokinetics (PK), (long-term) safety, and efficacy of brigatinib in these children.
- 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 1 to 25
You may be able to join if
- Patients must be 1 and \< 26 years of age at the time of enrollment, and able to swallow brigatinib tablets at the time of enrollment, with a minimum...
- Patients must have a confirmed diagnosis of cancer histologically at baseline. In patients where a repeat biopsy at relapse (or moment of refractory...
- Patients are required to provide prior results showing an activating ALK aberration in the tumor per local laboratory results, and material needs to...
- For Phase 1:
- Patients with ALCL must be relapsed/refractory or intolerant to standard therapies. Refractory disease for ALCL is defined as: o no response to...
You likely can't join if
- Patients meeting any of the following exclusion criteria are not to be enrolled in the study:
- Patients receiving systemic treatment with strong or moderate CYP3A inhibitors or inducers within 14 days or five half-life times whichever the less...
- Diagnosis of another concurrent primary malignancy.
- Clinically significant cardiovascular disease, including any of the following:
- Myocardial infarction or unstable angina within 6 months of study entry.
- History of or presence of heart block, and/or clinically significant ventricular or atrial arrhythmias.
See the full eligibility criteria
Who can join
- Patients must be 1 and \< 26 years of age at the time of enrollment, and able to swallow brigatinib tablets at the time of enrollment, with a minimum weight of 10 kg. Note: for phase 1 only patients ≤18 years old will...
- Patients must have a confirmed diagnosis of cancer histologically at baseline. In patients where a repeat biopsy at relapse (or moment of refractory disease) is considered not feasible by the treating physician...
- Patients are required to provide prior results showing an activating ALK aberration in the tumor per local laboratory results, and material needs to be available for central laboratory confirmation of ALK status. For...
- For Phase 1:
- Patients with ALCL must be relapsed/refractory or intolerant to standard therapies. Refractory disease for ALCL is defined as: o no response to ALCL99/other standard of care chemotherapy (SD or PD of measurable...
- Patients with relapsed/refractory (R/R) IMT must not be suitable for curative surgical resection without causing mutilation. Newly diagnosed patients with unresectable ALK+ IMT, or when surgery would imply severe...
- Patients with other solid tumors (excluding IMT) must have relapsed or refractory disease.
- For Phase 2, patients must have measurable and/or evaluable disease:
- Patients with ALCL must be relapsed/refractory. Refractory disease for ALCL is defined as:
- no response to ALCL99/other standard of care chemotherapy (SD or PD of measurable lesions), and/or
- MRD-positivity by qualitative PCR for NPM-ALK prophase after one block ALCL99/other standard of care chemotherapy (before the second course of chemotherapy).
- Patients with R/R IMT Relapsed/refractory ALK+ IMT, or newly diagnosed, including advanced and metastatic, ALK+ IMT which cannot be surgically resected without causing mutilation
- Performance Status: Karnofsky performance status ≥40% for patients \>16 years of age or Lansky Play Scale ≥40% for patients ≤16 years of age.
- Patients must not be receiving other investigational medications (defined as medicinal products not yet approved for any indications, including alternative/herbal therapies) within 30 days of first dose of study drug or...
- For patients receiving prior therapy:
- Patients who already received previous treatment with ALK inhibitors except for brigatinib can be included in this study.
- Patients must have recovered to Grade \<2 NCI CTCAE v5.0 or to baseline, from any nonhematologic toxicities (except alopecia and peripheral neuropathy) due to previous therapy.
- Patients who relapsed while receiving cytotoxic therapy: at least 14 days must have passed since the completion of the last dose of chemotherapy before the first dose of brigatinib can be given.
- Patients who have experienced relapse after a prior HSCT are eligible, provided they have no evidence of acute or chronic graft-versus-host disease (GVHD), are not receiving GVHD prophylaxis or treatment, and are at...
- Hematopoietic growth factors: before the first dose of brigatinib, at least 7 days must have passed since completion of therapy with granulocyte colony-stimulating factor or other growth factors, and at least 14 days...
- Biologics and Targeted Therapies: o Immunotherapy: Before the first dose of brigatinib, at least 30 days must have passed after the completion of any type of immunotherapy, (i.e. monoclonal antibodies [anti-PD1/PDL1]...
- Patients must meet the organ function and system function requirements as stated below:
- Patients must have adequate renal and hepatic function as indicated by the following laboratory values: o Patient's serum creatinine must be ≤ 1.5 x institutional upper limit of normal (ULN) according to age. If the...
- Adequate liver function defined as: direct bilirubin ≤1.5 times the upper limit of normal (ULN) for age AND AST and ALT must be ≤5 times the ULN for age (unless related to involvement of the liver or...
- No clinical, radiological or laboratory evidence of pancreatitis, including o Serum lipase must be \<2 × the ULN, and o Serum amylase must be \<2 × the ULN.
- Absolute neutrophil count: ≥0.75 × 10 9/L, except in case of macrophage activation syndrome (MAS) or bone marrow involvement.
- Platelet count o In phase 1: Platelet count: ≥75 × 10\^9/ L, except in case of MAS or bone marrow involvement o In phase 2: : Platelet count: ≥75 × 10\^9/ L, except in case of MAS or bone marrow involvement. For...
- Adequate cardiac function defined as shortening fraction ≥27% by echocardiogram OR left ventricular ejection fraction of ≥50% by multigated acquisition scan.
- Normal QT interval corrected per Fridericia method (QTcF) on screening electrocardiogram (ECG), defined as QTcF of ≤450 ms.
- Have a life expectancy of ≥3 months.
- Female patients of childbearing potential must have a negative urine or serum pregnancy test confirmed prior to enrollment.
- Female patients with infants must agree not to breastfeed their infants while on this study.
- Contraception:
- Male and female patients of child-bearing potential must agree to use, an effective method for male and highly effective method for female, of contraception approved by the investigator during the study, following the...
- Highly effective methods of contraception include (but not exclusively) the following contraceptive methods: o combined (estrogen- and progestogen-containing) hormonal contraception associated with inhibition of...
- progestogen-only hormonal contraception associated with inhibition of ovulation
- intrauterine device (IUD), intrauterine hormone-releasing system (IUS), sexual abstinence.
- Voluntary written informed consent according to law and regulations \-
What rules you out
- Patients meeting any of the following exclusion criteria are not to be enrolled in the study:
- Patients receiving systemic treatment with strong or moderate CYP3A inhibitors or inducers within 14 days or five half-life times whichever the less prior to the first dose of study drug (refer to Section 5.2 for a list...
- Diagnosis of another concurrent primary malignancy.
- Clinically significant cardiovascular disease, including any of the following:
- Myocardial infarction or unstable angina within 6 months of study entry.
- History of or presence of heart block, and/or clinically significant ventricular or atrial arrhythmias.
- Uncontrolled hypertension defined as persistent elevation of systolic and/or diastolic blood pressures to ≥95th percentile based on age, sex, and height percentiles despite appropriate antihypertensive management.
- Planned non-protocol chemotherapy, radiation therapy, another investigational agent, or immunotherapy while patient is on study treatment.
- Any illness that affects gastrointestinal absorption.
- Ongoing or active systemic infection, active seropositive HIV, or known active hepatitis B or C infection.
- Any pre-existing condition or illness that, in the opinion of the investigator or sponsor, would compromise patient safety or interfere with the evaluation of the safety or how well it works of brigatinib.
- Patients with a history of cerebrovascular ischemia/hemorrhage with residual deficits are not eligible (patients with a history of cerebrovascular ischemia/hemorrhage remain eligible provided all neurologic deficits...
- Uncontrolled seizure disorder (patients with seizure disorders that do not require antiepileptic drugs, or are well controlled with stable doses of antiepileptic drugs are eligible).
The study team makes the final eligibility decision.
Where it's taking place
- Paris, France
- Utrecht, Utrecht, Netherlands
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, 1 year to 25 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Paris, France; Utrecht, Utrecht, Netherlands. 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.