CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 238 enrolled
Drug / intervention
Cladribine, Cyclophosphamide, Cytarabine, Daunorubicin, Dexamethasone +1 moredrug
Likely dose
Not stated in record
Key inclusion· 4
  • Diagnosis of acute myeloid leukemia, myelodysplasia, or biphenotypic leukemia confirmed by immunophenotyping, morphology, and/or cytochemical staining
  • Age ≤21 years at study entry
  • No prior therapy for this malignancy except one dose of intrathecal therapy (patients with secondary AML following treatment of primary malignancy are eligible)
  • Negative pregnancy test
Key exclusion· 4
  • Positive pregnancy test
  • Down syndrome
  • Acute promyelocytic leukemia (APL)
  • Juvenile myelomonocytic leukemia (JMML)

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

Search/NCT00136084
NCT00136084Phase 3Completed

A Collaborative Trial for the Treatment of Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplasia

St. Jude Children's Research Hospital·interventional·Posted Aug 26, 2005·Updated Dec 5, 2012

In Brief

A Phase 3 clinical trial evaluating Cladribine, Cyclophosphamide, Cytarabine, Daunorubicin, Dexamethasone and Etoposide, Cytarabine, Gemtuzumab, L-asparaginase, Mercaptopurine, methotrexate, Mitoxantrone, Prednisone, Vincristine for Leukemia, Myelocytic, Acute. Completed, enrolled 238 participants across 8 sites.

Detailed Summary

The purpose of this study is to compare the effectiveness of two multi-agent chemotherapy regimens using different dosages of cytarabine to eliminate all detectable leukemia.

Study Details

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

Timeline

Phase 3CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 26, 2005
Enrollment StartAug 1, 2002
Primary CompletionJul 1, 2008
Study CompletionJun 1, 2012
TodayJul 2, 2026
Enrollment to primary: 5.9 yearsPosted 20.8 years ago

Interventions

Cladribine, Cyclophosphamide, Cytarabine, Daunorubicin, Dexamethasonedrug

Since limited characters are allowed in this passage, please see detailed Description to know the dosage, dosage form, frequency of administration for the above mentioned drugs

Etoposide, Cytarabine, Gemtuzumab, L-asparaginase, Mercaptopurine, methotrexate, Mitoxantrone, Prednisone, Vincristinedrug

Since limited characters are allowed in this passage, please see detailed Description to know the dosage, dosage form, frequency of administration for the above mentioned drugs