CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 501 enrolled
Drug / intervention
Prednisone, Dexamethasone, Vincristine, Daunorubicin +5 moredrug
Likely dose
Not stated in record
Key inclusion· 2
  • Age 1 to 18 years (inclusive)
  • Diagnosis of non-B-cell ALL confirmed by immunophenotyping with flow cytometry, morphology, and cytochemical staining
Key exclusion· 1
  • Prior chemotherapy treatment for one week or longer

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

Search/NCT00137111
NCT00137111Phase 3Completed

Total XV - Total Therapy Study XV for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia

St. Jude Children's Research Hospital·interventional·Posted Aug 29, 2005·Updated Sep 11, 2020

In Brief

A Phase 3 clinical trial evaluating Prednisone, Dexamethasone, Vincristine, Daunorubicin, Doxorubicin, L-asparaginase, PEG-L-asparaginase, Erwinia asparaginase, and 4 other interventions for Lymphoblastic Leukemia, Acute. Completed, enrolled 501 participants across 2 sites.

Detailed Summary

The primary objective is to estimate the overall event-free survival of children at least one year of age at diagnosis who are treated with risk-directed therapy and to monitor the molecular remission induction rate.

Study Details

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

Timeline

Phase 3CompletedFinished
2000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 29, 2005
Enrollment StartJul 8, 2000
Primary CompletionNov 1, 2010
Study CompletionApr 1, 2014
TodayJul 2, 2026
Enrollment to primary: 10.3 yearsPosted 20.8 years ago

Interventions

Prednisone, Dexamethasone, Vincristine, Daunorubicindrug

See Detailed Description sections for details on treatment interventions.

Doxorubicin, L-asparaginase, PEG-L-asparaginase, Erwinia asparaginasedrug

See Detailed Description sections for details on treatment interventions.

Methotrexate, Cyclophosphamide, Cytarabine, Etoposidedrug

See Detailed Description sections for details on treatment interventions.

Mercaptopurine, Imatinibdrug

See Detailed Description sections for details on treatment interventions.

chemotherapy, intrathecal chemotherapyprocedure

See Detailed Description sections for details on treatment interventions.

steroid therapy, hematopoietic stem cell transplantationprocedure

See Detailed Description sections for details on treatment interventions.