CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 9,350 enrolled
Drug / intervention
Cyclophosphamide +12 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01190930
NCT01190930Phase 3Completed

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

Children's Oncology Group·interventional·Posted Aug 30, 2010·Updated May 28, 2026

In Brief

A Phase 3 clinical trial evaluating Cyclophosphamide, Cytarabine, and 11 other interventions for Acute Lymphoblastic Leukemia and 9 related conditions. Completed, enrolled 9,350 participants across 243 sites in 7 countries.

Detailed 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.

Study Details

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedAug 30, 2010
Enrollment StartAug 11, 2010
Primary CompletionMar 31, 2019
Study CompletionMar 31, 2026
TodayJul 2, 2026
Enrollment to primary: 8.6 yearsPosted 15.8 years ago

Interventions

Cyclophosphamidedrug

Given IV

Cytarabinedrug

Given IT, IV, or SC

Dexamethasonedrug

Given orally (PO) or IV

Doxorubicin Hydrochloridedrug

Given IV

Laboratory Biomarker Analysisother

Correlative studies

Leucovorin Calciumdrug

Given PO

Mercaptopurinedrug

Given PO

Methotrexatedrug

Given IT, PO, or IV

Pegaspargasedrug

Given IV

Quality-of-Life Assessmentother

Ancillary studies

Questionnaire Administrationother

Ancillary studies

Thioguaninedrug

Given PO

Vincristine Sulfatedrug

Given IV