CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 393 enrolled
Drug / intervention
asparaginase +12 moredrug
Likely dose
Not stated in record
Key inclusion· 5
  • Newly diagnosed disseminated lymphoblastic lymphoma or localized lymphoblastic lymphoma
  • Stage III or IV disease
  • Less than 25% tumor cells in the bone marrow
  • Age 1 to 30 years
Key exclusion· 2
  • Prior treatment except intrathecal cytarabine (if protocol therapy begins within 72 hours) and emergency therapy for airway obstruction/superior vena cava syndrome
  • No prior therapy except emergency treatment of airway obstruction and/or superior vena cava syndrome

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

Search/NCT00004228
NCT00004228Phase 3Completed

Randomized Phase III Study for the Treatment of Newly Diagnosed Disseminated Lymphoblastic Lymphoma or Localized Lymphoblastic Lymphoma

Children's Oncology Group·interventional·Posted Jan 27, 2003·Updated Aug 6, 2019

In Brief

A Phase 3 clinical trial evaluating asparaginase, cyclophosphamide, and 11 other interventions for Lymphoma. Completed, enrolled 393 participants across 176 sites in 5 countries.

Detailed Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. It is not yet known which regimen of combination chemotherapy is most effective for lymphoblastic lymphoma. PURPOSE: This randomized phase III trial is studying different regimens of combination chemotherapy to compare how well they work in treating children or adolescents with newly diagnosed stage III or stage IV lymphoblastic lymphoma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLymphoma
CountriesAustralia, Canada, Puerto Rico, Switzerland, United States

Timeline

Phase 3CompletedFinished
2000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 27, 2003
Enrollment StartJun 1, 2000
Primary CompletionAug 1, 2008
Study CompletionMar 31, 2015
TodayJul 2, 2026
Enrollment to primary: 8.2 yearsPosted 23.4 years ago

Interventions

asparaginasedrug

Given IV

cyclophosphamidedrug

Given IV

cytarabinedrug

Given IV

daunorubicin hydrochloridedrug

Given IV

dexamethasonedrug

Given IV

doxorubicin hydrochloridedrug

Given IV

leucovorin calciumdrug

Given IV

mercaptopurinedrug

Given IV

methotrexatedrug

Given IV

prednisonedrug

Given IV

thioguaninedrug

Given PO

vincristine sulfatedrug

Given IV

radiation therapyradiation