Ivosidenib in Treating Patients With Advanced Solid Tumors, Lymphoma, or Histiocytic Disorders Wi… (NCT04195555) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Ivosidenib in Treating Patients With Advanced Solid Tumors, Lymphoma, or Histiocytic Disorders With IDH1 Mutations (A Pediatric MATCH Treatment Trial)
United States, Australia, Puerto Rico3 participantsStarted 2020-07-20
Plain-language summary
This phase II Pediatric MATCH trial studies how well ivosidenib works in treating patients with solid tumors, including central nervous system tumors, lymphomas and histiocytic disorders that have not responded to (refractory) or have come back after (recurrent) prior treatment that have IDH (isocitrate dehydrogenase) 1 genetic alterations (mutations). Ivosidenib may block the growth of cancer cells that have specific genetic changes in an important signaling pathway called the IDH pathway.
Who can participate
Age range
12 Months – 21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient must have enrolled onto APEC1621SC (NCT03155620) and must have been given a treatment assignment to MATCH to APEC1621K based on the presence of an actionable mutation as defined in APEC1621SC
* Patients must be \>= than 12 months and =\< 21 years of age at the time of study enrollment
* Patients must have a body surface area \>= 0.78 m\^2 at enrollment
* Patients must be able to swallow intact tablets
* Patients must have radiographically measurable disease at the time of study enrollment. Patients with neuroblastoma who do not have measurable disease but have metaiodobenzylguanidine (MIBG)+ evaluable disease are eligible. Measurable disease in patients with CNS involvement is defined as any lesion that is at minimum 10 mm in one dimension on standard magnetic resonance imaging (MRI) or computed tomography (CT)
* Note: The following do not qualify as measurable disease:
* Malignant fluid collections (e.g., ascites, pleural effusions)
* Bone marrow infiltration except that detected by MIBG scan for neuroblastoma
* Lesions only detected by nuclear medicine studies (e.g., bone, gallium or positron emission tomography \[PET\] scans) except as noted for neuroblastoma
* Elevated tumor markers in plasma or cerebrospinal fluid (CSF)
* Previously radiated lesions that have not demonstrated clear progression post radiation
* Leptomeningeal lesions that do not meet the measurement requirements for Response Evaluation Criteria in…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is specifically for children with IDH1 mutations — has my child's tumor been tested for an IDH1 mutation, and if not, is that testing something we should pursue to see if this even applies to us?
2Since the trial is no longer actively enrolling new patients, is there any chance my child could still be considered for a spot, or are there other IDH1-targeted trials we should be looking into instead?
3This is a Phase 2 trial measuring how many patients have a complete or partial response to ivosidenib — based on what's been reported so far, what does the response rate data suggest about the realistic benefit for a cancer like my child's specific diagnosis?
4What are the known side effects of ivosidenib in pediatric patients, and are there any risks that are particularly important to watch for given my child's current condition and treatment history?
5Before considering a trial like this, are there any standard treatments or other approved options we haven't yet tried that might be worth pursuing first, given that this drug is still being studied in children?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Objective Response Rate (ORR; Complete Response + Partial Response) in Pediatric Patients Treated With Ivosidenib