CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 60 enrolled
Drug / intervention
aminopterin +11 moredrug
Likely dose
Not stated in record
Key inclusion· 5
  • Newly diagnosed ALL excluding mature B-cell ALL (surface Ig positive)
  • Patients with overt CNS or testicular disease are eligible
  • Age greater than 1 year and less than 29.99 years
  • Adequate organ function required
Key exclusion· 3
  • Medical, psychological, or psychiatric problems likely to compromise ability to tolerate intensive therapy
  • Significant organ dysfunction not attributable to ALL: cardiac ejection fraction <40%, total bilirubin >2, or serum creatinine >2
  • Clinically significant congestive heart failure

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

Search/NCT00176462
NCT00176462Phase 2Completed

CINJALL: Treatment for Children With Acute Lymphocytic Leukemia

Rutgers, The State University of New Jersey·interventional·Posted Sep 15, 2005·Updated Jun 9, 2014

In Brief

A Phase 2 clinical trial evaluating aminopterin, L-asparaginase, and 10 other interventions for Acute Lymphocytic Leukemia. Completed, enrolled 60 participants across 2 sites.

Detailed Summary

The purpose of this research study is to identify better ways to treat children and young adults with acute lymphocytic leukemia (ALL). At the same time, doctors hope to define methods to identify those patients at higher risk for certain side effects, as well as those who are at higher risk for relapse of their leukemia.

Study Details

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

Timeline

Phase 2CompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 15, 2005
Enrollment StartFeb 1, 2001
Primary CompletionSep 1, 2008
TodayJul 2, 2026
Enrollment to primary: 7.6 yearsPosted 20.8 years ago

Interventions

aminopterindrug

Therapy will be divided into five phases: Induction, Consolidation, Delayed Intensification (only for those patients meeting clinical criteria defining a high risk of relapse), Intensive Continuation, and Continuation

L-asparaginasedrug

Therapy will be divided into five phases: Induction, Consolidation, Delayed Intensification (only for those patients meeting clinical criteria defining a high risk of relapse), Intensive Continuation, and Continuation

cyclophosphamidedrug

Therapy will be divided into five phases: Induction, Consolidation, Delayed Intensification (only for those patients meeting clinical criteria defining a high risk of relapse), Intensive Continuation, and Continuation

cytarabinedrug

Therapy will be divided into five phases: Induction, Consolidation, Delayed Intensification (only for those patients meeting clinical criteria defining a high risk of relapse), Intensive Continuation, and Continuation

daunomycindrug

Therapy will be divided into five phases: Induction, Consolidation, Delayed Intensification (only for those patients meeting clinical criteria defining a high risk of relapse), Intensive Continuation, and Continuation

dexamethasonedrug

Therapy will be divided into five phases: Induction, Consolidation, Delayed Intensification (only for those patients meeting clinical criteria defining a high risk of relapse), Intensive Continuation, and Continuation

6-mercaptopurinedrug

Therapy will be divided into five phases: Induction, Consolidation, Delayed Intensification (only for those patients meeting clinical criteria defining a high risk of relapse), Intensive Continuation, and Continuation

methotrexatedrug

Therapy will be divided into five phases: Induction, Consolidation, Delayed Intensification (only for those patients meeting clinical criteria defining a high risk of relapse), Intensive Continuation, and Continuation

6-thioguaninedrug

Therapy will be divided into five phases: Induction, Consolidation, Delayed Intensification (only for those patients meeting clinical criteria defining a high risk of relapse), Intensive Continuation, and Continuation

vincristinedrug

Therapy will be divided into five phases: Induction, Consolidation, Delayed Intensification (only for those patients meeting clinical criteria defining a high risk of relapse), Intensive Continuation, and Continuation

Triple Intrathecal Therapy (MTX, Cytarabine, Hydrocortisone)drug

Leucovorindrug