CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 100 enrolled
Drug / intervention
prednisone +11 moredrug
Likely dose
E. coli L-asparaginase given intramuscularly weekly during intensification phase; initial asparaginase given intramuscularly on day 5 of inductionAI-extracted
Key inclusion· 4
  • ✓Pathologically documented acute lymphoblastic leukemia, excluding mature B-cell ALL
  • ✓Age 18 to 50 years
  • ✓ECOG performance status 0 to 2
  • ✓No prior therapy for leukemia except: up to one week of steroids, emergent leukapheresis, emergency hydroxyurea for hyperleukocytosis, one dose of cranial RT for CNS leukostasis, or emergent mediastinal radiation
Key exclusion· 6
  • ✕Uncontrolled active infection
  • ✕Pregnancy or nursing mothers
  • ✕Prior history of pancreatitis
  • ✕Prior history of cerebrovascular accident or hemorrhage

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

Search/NCT00136435
NCT00136435Phase 2Completed
CompareCT.gov

A Multicenter Phase II Study in Adults With Untreated Acute Lymphoblastic Leukemia: Testing Pharmacokinetically Individualized Doses of L-Asparaginase Following the Dana Farber Cancer Institute (DFCI) Pediatric Consortium Protocol

Dana-Farber Cancer Institute·interventional·Posted Aug 29, 2005·Updated Oct 20, 2025

In Brief

A Phase 2 clinical trial evaluating prednisone, doxorubicin, and 10 other interventions for Acute Lymphoblastic Leukemia. Completed, enrolled 100 participants across 12 sites in 2 countries.

Detailed Summary

The purpose of this study is to determine the safety and optimal dosing of L-asparaginase in adult patients with acute lymphoblastic leukemia (ALL) between the ages of 18 and 50 years.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Lymphoblastic Leukemia
CountriesCanada, United States
CollaboratorsBrigham and Women's Hospital, Massachusetts General Hospital, Queen Elizabeth II Health Sciences Centre

Timeline

Phase 2CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 29, 2005
Enrollment StartJun 1, 2002
Primary CompletionNov 1, 2008
Study CompletionMay 1, 2011
TodayJul 2, 2026
Enrollment to primary: 6.4 yearsPosted 20.8 years ago

Interventions

prednisonedrug

Induction Phase: Given orally on days 1-28

doxorubicindrug

Induction Phase: Given intravenously on day 1 and day 2 CNS Therapy: Given intravenously on day 1 Intensification: Given day 1 of each cycle

vincristinedrug

Induction: Given intravenously on days 1, 8, 15, and 22. If complete remission not achieved, will be given on days 29, 36 and 43. CNS Therapy: Given intravenously on day 1. Intensification: Given intravenously on day 1 of each cycle. Continuation: Given intravenously on day 1 of each cycle

methotrexatedrug

Induction: Given intravenously on day 3. CNS Therapy: Given intrathecally 4 times over two weeks Intensification: Given intrathecally every 18 weeks Continuation: Given intravenously weekly and intrathecally every 18 weeks

asparaginasedrug

Induction: Given into the muscle on day 5

dexamethasonedrug

Intensification: Given orally on days 1-5 of each cycle

cranial radiationradiation

Given in 10 daily treatments during CNS therapy phase

leucovorindrug

Induction: Given intravenously or orally 36 hours after methotrexate

cytarabinedrug

Induction: Given intrathecally days 1, 15, 29 CNS Therapy: Given intrathecally 4 times over 2 weeks Intensification: Given intrathecally every 18 weeks Continuation: Given intrathecally every 18 weeks

hydrocortisonedrug

Induction: Given intrathecally on days 15 and 29. Intensification: Given intrathecally every 18 weeks. Continuation: Given intrathecally every 18 weeks.

6-mercaptopurine (6-MP)drug

CNS Therapy: Taken orally on days 1-14. Intensification: Taken orally on days 1-14. Continuation: Taken orally on days 1-14.

e. coli L-asparaginasedrug

Intensification: Given in to the muscle weekly.