CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 104 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/NCT00866307
NCT00866307Phase 1Completed
CompareCT.gov

Intensified PEG-Asparaginase in High Risk Acute Lymphoblastic Leukemia (ALL): A Pilot Study

Children's Oncology Group·interventional·Posted Mar 20, 2009·Updated Apr 27, 2021

In Brief

A Phase 1 clinical trial evaluating Cyclophosphamide, Cytarabine, and 11 other interventions for Acute Lymphoblastic Leukemia and 2 related conditions. Completed, enrolled 104 participants across 28 sites in 3 countries.

Detailed Summary

This pilot clinical trial studies the side effects of pegaspargase when given together with combination chemotherapy in treating patients with newly diagnosed high-risk acute lymphoblastic leukemia. Pegaspargase may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. 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) together with pegaspargase may kill more cancer cells.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Lymphoblastic Leukemia, Adult B Acute Lymphoblastic Leukemia, Childhood B Acute Lymphoblastic Leukemia
CountriesAustralia, Canada, United States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 1CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 20, 2009
Enrollment StartFeb 23, 2009
Primary CompletionJun 30, 2014
Study CompletionMar 31, 2021
TodayJul 2, 2026
Enrollment to primary: 5.4 yearsPosted 17.3 years ago

Interventions

Cyclophosphamidedrug

Given IV

Cytarabinedrug

Given IT and IV or SC

Daunorubicin Hydrochloridedrug

Given IV

Dexamethasonedrug

Given IV

Doxorubicin Hydrochloridedrug

Given IV

Laboratory Biomarker Analysisother

Correlative studies

Mercaptopurinedrug

Given PO

Methotrexatedrug

Given IT and PO

Pegaspargasedrug

Given IV

Prednisonedrug

Given IV or PO

Prophylactic Cranial Irradiationradiation

Undergo radiation

Thioguaninedrug

Given PO

Vincristine Sulfatedrug

Given IV