OncRef

Clinical Trial: NCT00408005

Combination Chemotherapy in Treating Young Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma

Status:

COMPLETED

Phase:

Phase 3

Lead Sponsor:National Cancer Institute (NCI)
Information Provided By:National Cancer Institute (NCI)
Last Update Posted:2026-06-23

Study Overview

Brief Summary

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.

Official Title

Intensified Methotrexate, Nelarabine (Compound 506U78) and Augmented BFM Therapy for Children and Young Adults With Newly Diagnosed T-cell Acute Lymphoblastic Leukemia (ALL) or T-cell Lymphoblastic Lymphoma

Conditions

T Acute Lymphoblastic Leukemia, T Lymphoblastic Lymphoma

Intervention / Treatment

  • Drug: Asparaginase
  • Drug: Cyclophosphamide
  • Drug: Cytarabine
  • Drug: Daunorubicin Hydrochloride
  • Drug: Dexamethasone
  • Drug: Doxorubicin Hydrochloride
  • Other: Laboratory Biomarker Analysis
  • Drug: Leucovorin Calcium
  • Drug: Mercaptopurine
  • Drug: Methotrexate
  • Drug: Nelarabine
  • Drug: Pegaspargase
  • Drug: Prednisone
  • Radiation: Radiation Therapy
  • Drug: Thioguanine
  • Drug: Vincristine Sulfate

Other Study ID Numbers

  • NCI-2009-00307
  • NCI-2009-00307
  • COG-AALL0434
  • 07-169
  • CDR0000514500
  • AALL0434
  • AALL0434
  • U10CA098543
  • U10CA180886

Start Date (Actual)

2007-01-30

Primary Completion Date (Actual)

2017-09-30

Study Completion Date (Actual)

2025-03-31

Enrollment (Actual)

1895

Study Type

Interventional

Phase

Phase 3