Combination Chemotherapy in Treating Young Patients With Newly Diagnosed High-Risk B Acute Lympho… (NCT02883049) | Clinical Trial Compass
CompletedPhase 3
Combination Chemotherapy in Treating Young Patients With Newly Diagnosed High-Risk B Acute Lymphoblastic Leukemia and Ph-Like TKI Sensitive Mutations
United States, Australia, Canada5,949 participantsStarted 2012-02-29
Plain-language summary
This randomized phase III trial studies how well combination chemotherapy works in treating young patients with newly diagnosed B acute lymphoblastic leukemia that is likely to come back or spread, and in patients with Philadelphia chromosome (Ph)-like tyrosine kinase inhibitor (TKI) sensitive mutations. Chemotherapy drugs, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) and giving the drugs in different doses and in different combinations may kill more cancer cells.
Who can participate
Age range
1 Year – 31 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 must be enrolled on APEC14B1 and consented to Eligibility Screening on the Part A consent form prior to enrollment on AALL1131
* White Blood Cell Count (WBC) Criteria
* Age 1-9.99 years: WBC \>= 50 000/uL
* Age 10-30.99 years: Any WBC
* Age 1-30.99 years: Any WBC with:
* Testicular leukemia
* CNS leukemia (CNS3)
* Steroid pretreatment
* Patients must have newly diagnosed B lymphoblastic leukemia (2008 World Health Organization \[WHO\] classification) (also termed B-precursor acute lymphoblastic leukemia); patients with Down syndrome are also eligible
* Organ function requirements for patients with Ph-like ALL and a predicted TKI-sensitive mutation: patients identified as Ph-like with a TKI-sensitive kinase mutation must have assessment of organ function performed within 3 days of study entry onto the dasatinib arm of AALL1131
* Creatinine clearance or radioisotope glomerular filtration rate (GFR) \> 70mL/min/1.73 m\^2 or a serum creatinine based on age/gender as follows:
* Age: Maximum Serum Creatinine (mg/dL)
* 1 to \< 6 months: 0.4 (male) 0.4 (female)
* 6 months to \< 1 year: 0.5 (male) 0.5 (female)
* 1 to \< 2 years: 0.6 (male) 0.6 (female)
* 2 \< 6 years: 0.8 (male) 0.8 (female)
* 6 to \< 10 years: 1.0 (male) 1.0 (female)
* 10 to \< 13 years: 1.2 (male) 1.2 (female)
* 13 to \< 16 years: 1.5 (male) 1.4 (female)
* \> 16 years: 1.7 (male) 1.4 (female)
* Direct bilirubin =\< 3 x upper limit of normal (ULN)…
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
DFS of Non-DS HR Post-induction Patients Receiving Intrathecal (IT) Methotrexate (MTX) Compared With Patients Receiving Intrathecal Triple Therapy (ITT) on a Modified Berlin-Frankfurt-Munster (MBFM) Interim Maintenance High-dose Methotrexate Backbone
Timeframe: At 5 years
2
DFS of Non-DS VHR Post-Induction Patients Who Receive a Modified MBFM-IMHDM Regimen That Contains a Second IM (Control Arm) Compared to Patients Receive the Cyclophosphamide + Etoposide Containing Regimen (Experimental Arm 1)