CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 63 enrolled
Drug / intervention
Asparaginase +18 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/NCT00720109
NCT00720109Phase 3Completed
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Intensified Tyrosine Kinase Inhibitor Therapy (Dasatinib NSC# 732517) in Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (ALL)

National Cancer Institute (NCI)·interventional·Posted Jul 22, 2008·Updated Apr 13, 2020

In Brief

A Phase 3 clinical trial evaluating Asparaginase, Cyclophosphamide, and 17 other interventions for Acute Lymphoblastic Leukemia and 2 related conditions. Completed, enrolled 63 participants across 134 sites in 5 countries.

Detailed Summary

This phase II/III trial is studying the side effects and how well giving dasatinib together with combination chemotherapy works in treating young patients with newly diagnosed acute lymphoblastic leukemia (ALL). Dasatinib 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 or by stopping them from dividing. Giving dasatinib together with combination chemotherapy may kill more cancer cells.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Lymphoblastic Leukemia, Adult B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1, Childhood B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1
CountriesAustralia, Canada, New Zealand, Puerto Rico, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 22, 2008
Enrollment StartJul 14, 2008
Primary CompletionDec 31, 2014
Study CompletionMar 31, 2020
TodayJul 2, 2026
Enrollment to primary: 6.5 yearsPosted 17.9 years ago

Interventions

Asparaginasedrug

Given IT

Cyclophosphamidedrug

Given IV

Cytarabinedrug

Given IT or IV

Dasatinibdrug

Given PO

Daunorubicin Hydrochloridedrug

Given IV

Dexamethasonedrug

Given IV or PO

Etoposidedrug

Given IV

Filgrastimbiological

Given IV or SC

Hydrocortisone Sodium Succinatedrug

Given IT

Ifosfamidedrug

Given IV

Laboratory Biomarker Analysisother

Correlative studies

Leucovorin Calciumdrug

Given IV or PO

Mercaptopurinedrug

Given PO

Methotrexatedrug

Given IT, PO, or IV

Methylprednisolonedrug

Given IV

Pegaspargasedrug

Given IM

Prednisonedrug

Given PO or IV

Radiation Therapyradiation

Some patients undergo cranial RT

Vincristine Sulfatedrug

Given IV