Combination Chemotherapy in Treating Children With Acute Lymphoblastic Leukemia (NCT00005585) | Clinical Trial Compass
CompletedPhase 3
Combination Chemotherapy in Treating Children With Acute Lymphoblastic Leukemia
United States, Australia, Canada838 participantsStarted 2000-04
Plain-language summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. It is not yet known which regimen of combination chemotherapy is more effective for childhood acute lymphoblastic leukemia.
PURPOSE: This randomized phase III trial is comparing different regimens of combination chemotherapy to see how well they work in treating children with acute lymphoblastic leukemia.
Who can participate
Age range
1 Year – 9 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.
DISEASE CHARACTERISTICS:
* Diagnosis of B-cell precursor acute lymphoblastic leukemia
* Registered on POG-9900 Classification Study
* Registered within 7 days of documenting complete response (CR) after induction therapy on day 29 or, if 2 more weeks of induction are required, within 7 days of CR determination
* Classified as low-risk:
* WBC less than 50,000/mm\^3
* Age 1 to 9
* No adverse translocations \[E2A-PBX1, t(1;19) or BCR/ABL, t(9;22); and MLL rearrangements\]
* No CNS 3 disease (CSF WBC at least 5/mm\^3 with blasts present)
* No testicular disease
* At least one of the following present:
* TEL/AML1, t(12;21)
* Simultaneous trisomy of chromosomes 4 and 10
PATIENT CHARACTERISTICS:
Age:
* 1 to 9
Performance status:
* Not specified
Life expectancy:
* Not specified
Hematopoietic:
* See Disease Characteristics
Hepatic:
* Not specified
Renal:
* Not specified
Other:
* Not pregnant or nursing
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* Not specified
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* Not specified
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
Event-free survival
Timeframe: 4 years
2
Occurrence of anticipated failures
Timeframe: Up to 7 years
3
Grade 3 or greater CNS toxicity rates assessed using NCI CTC version 2.0