CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 30 enrolled
Drug / intervention
Prednisone +8 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/NCT00973752
NCT00973752Phase 2Completed

Treatment of Older Adults With Acute Lymphoblastic Leukemia

Massachusetts General Hospital·interventional·Posted Sep 9, 2009·Updated Mar 30, 2017

In Brief

A Phase 2 clinical trial evaluating Prednisone, Vincristine, and 7 other interventions for Acute Lymphoblastic Leukemia. Completed, enrolled 30 participants across 3 sites.

Detailed Summary

The purpose of this study is to determine the safety and effectiveness of a multi-drug regimen (which includes prednisone, vincristine, cytarabine, doxorubicin, 6 mercaptopurine, and methotrexate) which is considered standard treatment for children and young adults with acute lymphoblastic leukemia (ALL), in combination with PEG-asparaginase and clofarabine to treat older adults with ALL. PEG-asparaginase has been used in chemotherapy treatment regimens for both children and adults with ALL. Clofarabine has been used in chemotherapy treatment regimens for children with ALL and has been shown to decrease the number of leukemia cells. Participants with leukemia that has an abnormal chromosome, called the Philadelphia chromosome, will also be given imatinib.

Study Details

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

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 9, 2009
Enrollment StartAug 1, 2009
Primary CompletionDec 1, 2014
Study CompletionApr 1, 2016
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 16.8 years ago

Interventions

Prednisonedrug

Orally during Induction, Consolidation 1, CNS, Consolidation 2, and Continuation therapy.

Vincristinedrug

Intravenously during Induction, CNS, Consolidation 2 and Continuation Therapy

Doxorubicindrug

Intravenously during Induction, CNS, and Consolidation 2 therapy

PEG-asparaginasedrug

Intravenously during Induction, Consolidation 1, CNS, and Consolidation 2 therapy

Cytarabinedrug

Intrathecally during Induction and CNS therapy

Methotrexatedrug

Intrathecally during Induction, CNS, and Continuation Therapy

Imatinibdrug

Orally during Induction, Consolidation 1, CNS, Consolidation 2 and Continuation Therapy

Clofarabinedrug

Intravenously during Consolidation 1 Therapy

6 Mercaptopurinedrug

Orally during CNS, Consolidation 2 and Continuation Therapy