MinorTrial status: Active, Not Recruiting to Completed
Study completion date changed from estimate of Mar 7, 2025 to Mar 31, 2025
Start date: Jan 22, 2007 to Jan 30, 2007
v667
MinorStudy sites revised (215)v666
2 versionsRe-verified since Dec 3, 2024, no change to tracked fieldsv664-v665
MinorStudy sites revised (215)v663
Show 44 earlier versionsHide 44 earlier versions
MinorStudy sites revised (215)v662
MinorStudy sites revised (215)v661
MinorStudy sites revised (215)v660
Re-verified, no change to tracked fieldsv659
MinorStudy sites revised (215)v658
MinorStudy completion date: Mar 7, 2025v657
Re-verified, no change to tracked fieldsv656
MinorStudy sites revised (215)v655
2 versionsRe-verified since Nov 7, 2023, no change to tracked fieldsv653-v654
MinorSite details revised at 1 of 215 sitesv652
3 versionsRe-verified since Mar 7, 2023, no change to tracked fieldsv649-v651
MinorStudy sites revised (215)v648
Re-verified, no change to tracked fieldsv647
MinorStudy sites revised (215)v646
MinorStudy sites: 216 to 215v645
MinorStudy sites: 215 to 216v644
Re-verified, no change to tracked fieldsv643
MinorStudy sites revised (215)v642
3 versionsRe-verified since May 4, 2021, no change to tracked fieldsv639-v641
MinorStudy sites revised (215)v638
5 versionsRe-verified since Feb 2, 2021, no change to tracked fieldsv633-v637
MinorStudy sites revised (215)v632
2 versionsRe-verified since Oct 13, 2020, no change to tracked fieldsv630-v631
MinorStudy sites revised (215)v629
MinorStudy sites revised (215)v628
2 versionsRe-verified since Apr 14, 2020, no change to tracked fieldsv626-v627
MinorStudy sites revised (215)v625
MinorTrial status: Completed to Active, Not Recruiting
Study completion date: Dec 31, 2017 to not stated
Study sites revised (215)
v624
NotableResults first posted: Jun 20, 2019
Primary endpoints: 3 to 5
Study completion date: Sep 30, 2017 to Dec 31, 2017
Secondary endpoint revised
v623
MinorTrial status: Active, Not Recruiting to Completed
Study completion date: Sep 30, 2017
v622
Re-verified, no change to tracked fieldsv621
NotablePrimary endpoints: 6 to 3v620Show 4 more changesShow less
Secondary endpoints: 2 to 1
Study description expanded, about 24 words
Study sites revised (215)
Study arms: 16 to 17
Re-verified, no change to tracked fieldsv619
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This randomized phase III trial is studying different combination chemotherapy regimens and their side effects and comparing how well they work in treating young patients with newly diagnosed T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma. After a common induction therapy, patients were risk assigned and eligible for one or both post-induction randomizations: Escalating dose Methotrexate versus High Dose Methotrexate in Interim Maintenance therapy, No Nelarabine versus Nelarabine in Consolidation therapy. T-ALL patients are risk assigned as Low Risk, Intermediate Risk or High Risk. Low Risk patients are not eligible for the Nelarabine randomization, Patients with CNS disease at diagnosis were assgined to receive High Dose Methotrexate, patients who failed induction therapy were assigned to receive Nelarabine and High Dose Methotrexate. T-LLy patients were all assigned to escalating dose Methotrexate and were risk assigned as Standard Risk, High Risk and induction failures. Standard risk patients did not receive nelarabine, High risk T-LLy patients were randomized to No Nelarabine versus Nelarabine, and Induction failures were assigned to receive Nelarabine.