A Study of the Drug IMGN632 in Children With Leukemia That Has Come Back After Treatment or is Di… (NCT05320380) | Clinical Trial Compass
WithdrawnPhase 1/2
A Study of the Drug IMGN632 in Children With Leukemia That Has Come Back After Treatment or is Difficult to Treat
Stopped: Withdrawn per CS0150757
0Started 2023-08-01
Plain-language summary
This phase I/II trial finds the highest safe dose of IMGN632 that can be given with other chemotherapy without causing severe side effects, studies what kind of side effects IMGN632 may cause, and determines whether IMGN632 is a beneficial treatment for leukemia in children that has come back after treatment or is difficult to treat. IMGN632 is a monoclonal antibody linked to a chemotherapy drug. IMGN632 is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as CD123 receptors, and delivers the chemotherapy drug to kill them. Giving IMGN632 with other chemotherapy may cause the leukemia to stop growing or to shrink for a period of time.
Who can participate
Age range
12 Months – 22 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:
* Patients from Children's Oncology Group (COG) sites must be enrolled on APAL2020SC
* Patients must be \>= 12 months and less than 22 years of age at the time of study enrollment
* Patient's weight at time of enrollment must be \>= 10 kg
* Patients must meet the eligibility in the appropriate Cohort for their diagnosis and disease status
* Cohort 1 (Phase 1 Monotherapy):
* Patients must meet all the following criteria:
* Patient must have bone marrow sample showing \>= 5% leukemic blasts by flow cytometry
* Patient must have been diagnosed with AML, B-ALL, T-ALL, or mixed phenotype acute leukemia (MPAL) meeting one of the following disease criteria:
* Second or greater relapse OR
* Disease that is refractory to relapse therapy
* Refractory to relapse therapy is defined as persistent disease after at least one cycle of induction chemotherapy to treat the relapse disease
* Patient must have leukemic blasts that are CD123-positive by flow cytometry as determined either by the treating institution or through reference laboratory testing.
* Cohort 2 (Combination Dose Finding) and Cohort 3 (Randomized Phase 2 Combination):
* Patients must meet all the following criteria:
* Patient must have AML in first relapse with a bone marrow sample showing \>= 1% leukemic blasts by flow cytometry
* Patient must have leukemic blasts that are CD123-positive by flow cytometry as determined either by t…
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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
Recommended phase 2 dose (RP2D) of IMGN632 monotherapy (Cohort 1)