Phase IIII randomized study of augmented Berlin-Frankfurt-Münster-86 multiagent chemotherapy, intensified methotrexate, and nelarabine in younger patients with newly diagnosed T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma

eagle-i ID

Resource Type

Properties

1. Intervention

   Methotrexate

2. Intervention

   Leucovorin calcium

3. Intervention

   Mercaptopurine

4. Intervention

   Pegaspargase

5. Intervention

   Berlin-Frankfurt-Münster-86 multi-agent chemotherapy

6. Intervention

   Nelarabine

7. Additional Topic(s)

   Antineoplastic combined chemotherapy protocols

8. Additional Topic(s)

   Drug dosage

9. Resource Description

   There are three primary objectives of this study, as follows: To compare the relative safety and efficacy of augmented Berlin-Frankfurt-Münster-86 multiagent chemotherapy with or without nelarabine in younger patients with newly diagnosed T-cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-NHL). To compare the relative safety and efficacy of interim maintenance therapy comprising high-dose methotrexate (with leucovorin calcium rescue) and mercaptopurine vs escalating-dose methotrexate (without leucovorin calcium rescue) and pegaspargase in these patients. To gain preliminary data on the use of nelarabine in patients with high-risk T-NHL and its effect on long-term survival. Secondary objectives are as follows: To determine the relative safety and efficacy of withholding radiotherapy in patients with low -risk T-ALL and administering prophylactic cranial radiotherapy in patients with intermediate- or high-risk T-ALL. To characterize T-NHL biologic samples using conventional immunophenotyping, cytogenetic analysis, detection of activating Notch 1 mutations, comparative genomic hybridization (CGH), and gene expression profiling, and correlate these with long-term survival and identify potential targets for future therapy.

10. Contact

    Berenberg, Jeffrey

11. PI

    Wilkinson, Robert, M.D.

12. Topic

    precursor T-lymphoblastic lymphoma/leukemia

13. Study Population

    Patients aged 1 to 30 years with T-cell ALL

14. Website(s)

    http://www.cancer.gov/clinicaltrials/search/view?version=healthprofessional&cdrid=514500

15. Funded by

    Children's Oncology Group

16. Phase

    Phase 3 clinical trial

17. Performed by

    Clinical Protocol & Data Management Shared Resource