Safety of Clofarabine With Multiagent Chemotherapy in Childhood Acute Lymphoblastic Leukemia (NCT01279096) | Clinical Trial Compass
CompletedPhase 1
Safety of Clofarabine With Multiagent Chemotherapy in Childhood Acute Lymphoblastic Leukemia
France20 participantsStarted 2010-01
Plain-language summary
The purpose of this study is to determine Maximum Tolerated Dosage (MTD), Dosage Limited Toxicities (DLT), and the Rate Phase 2 Dosage of clofarabine when used in combination with etoposide, asparaginase, mitoxantrone and dexamethasone and to assess the feasibility and safety of this combination regimen to treat children with high risk relapsed or refractory acute lymphoblastic leukemia (ALL).
Who can participate
Age range
1 Year – 23 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:
* 1 to 21 years old at the date of acute lymphoblastic leukemia initial diagnosis
* Very early medullary first relapse occurring during the first 18th months after complete remission OR patients with second relapse OR a relapse occurring 6 months or more after myeloablative stem cell transplantation will be eligible.
* Have a Karnofsky Performance Status (KPS) of ≥70 for patients \>10 years of age or a Lansky Performance Status (LPS) of ≥60 for patients ≤10 years of age.
* No concomitant malignant disease.
* No active uncontrolled infection.
* Have adequate renal and hepatic functions
* absence of concomitant severe cardiovascular disease, i.e. congestive heart failure
* Female patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment.
* Male and female patients must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment.
Exclusion Criteria:
* Current concomitant chemotherapy, radiation therapy, or immunotherapy other than as specified in the protocol.
* Use of any investigational agent within 30 days.
* Known hypersensitivity to clofarabine or excipients.
* Known hypersensitivity to mitoxantrone, etoposide or excipients.
* Allergy to both E Coli-Asparaginase and Erwinia Asparaginase
* Prior transplant less than 6 months ago.
* Trisomy 21
* Have any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving …
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
maximum tolerated dose of clofarabine in combination with etoposide, asparaginase, mitoxantrone and dexamethasone
Timeframe: within the 40 days after the chemotherapy