CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 166 enrolled
Drug / intervention
Calaspargase Pegol-mknl +14 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/NCT00671034
NCT00671034Phase 3Completed

A Pilot Study of Intravenous EZN-2285 (SC-PEG E. Coli L-asparaginase) or Intravenous Oncaspar® in the Treatment of Patients With High-Risk Acute Lymphoblastic Leukemia (ALL)

Children's Oncology Group·interventional·Posted May 2, 2008·Updated Apr 27, 2021

In Brief

A Phase 3 clinical trial evaluating Calaspargase Pegol-mknl, Cyclophosphamide, and 13 other interventions for Acute Lymphoblastic Leukemia and 2 related conditions. Completed, enrolled 166 participants across 27 sites.

Detailed Summary

This randomized clinical trial is studying giving calaspargase pegol together with combination chemotherapy to see how well it works compared with giving pegaspargase together with combination chemotherapy in treating younger patients with newly diagnosed high-risk acute lymphoblastic leukemia. 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 2, 2008
Enrollment StartJul 21, 2008
Primary CompletionFeb 1, 2011
Study CompletionMar 31, 2021
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 18.2 years ago

Interventions

Calaspargase Pegol-mknldrug

Given IV

Cyclophosphamidedrug

Given IV

Cytarabinedrug

Given IV, IT, PO, or SC

Daunorubicin Hydrochloridedrug

Given IV

Dexamethasonedrug

Given PO or IV

Doxorubicin Hydrochloridedrug

Given IV

Laboratory Biomarker Analysisother

Correlative studies

Mercaptopurinedrug

Given PO

Methotrexatedrug

Given IV, IT, or PO

Pegaspargasedrug

Given IV

Pharmacological Studyother

Correlative studies

Prednisonedrug

Given IV or PO

Radiation Therapyradiation

Some patients undergo RT

Thioguaninedrug

Given PO

Vincristine Sulfatedrug

Given IV