OncRef

Clinical Trial: NCT01190930

Risk-Adapted Chemotherapy in Treating Younger Patients With Newly Diagnosed Standard-Risk Acute Lymphoblastic Leukemia or Localized B-Lineage Lymphoblastic Lymphoma

Status:

COMPLETED

Phase:

Phase 3

Lead Sponsor:Children's Oncology Group
Information Provided By:Children's Oncology Group
Last Update Posted:2026-05-28

Study Overview

Brief Summary

This partially randomized phase III trial studies the side effects of different combinations of risk-adapted chemotherapy regimens and how well they work in treating younger patients with newly diagnosed standard-risk acute lymphoblastic leukemia or B-lineage lymphoblastic lymphoma that is found only in the tissue or organ where it began (localized). Drugs used in chemotherapy 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), giving the drugs in different doses, and giving the drugs in different combinations may kill more cancer cells.

Official Title

Treatment of Patients With Newly Diagnosed Standard Risk B-Lymphoblastic Leukemia (B-ALL) or Localized B-Lineage Lymphoblastic Lymphoma (B-LLy)

Conditions

Acute Lymphoblastic Leukemia, Adult B Lymphoblastic Lymphoma, Ann Arbor Stage I B Lymphoblastic Lymphoma, Ann Arbor Stage II B Lymphoblastic Lymphoma, Childhood B Acute Lymphoblastic Leukemia, Childhood B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1, Childhood B Lymphoblastic Lymphoma, Down Syndrome, Hypodiploid B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Positive

Intervention / Treatment

  • Drug: Cyclophosphamide
  • Drug: Cytarabine
  • Drug: Dexamethasone
  • Drug: Doxorubicin Hydrochloride
  • Other: Laboratory Biomarker Analysis
  • Drug: Leucovorin Calcium
  • Drug: Mercaptopurine
  • Drug: Methotrexate
  • Drug: Pegaspargase
  • Other: Quality-of-Life Assessment
  • Other: Questionnaire Administration
  • Drug: Thioguanine
  • Drug: Vincristine Sulfate

Other Study ID Numbers

  • AALL0932
  • NCI-2011-02599
  • CDR0000683227
  • 11-00080
  • AALL0932
  • AALL0932
  • U10CA098543
  • U10CA180886

Start Date (Actual)

2010-08-11

Primary Completion Date (Actual)

2019-03-31

Study Completion Date (Actual)

2026-03-31

Enrollment (Actual)

9350

Study Type

Interventional

Phase

Phase 3