CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 165 enrolled
Drug / intervention
Bortezomib +5 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/NCT01420926
NCT01420926Phase 2Completed

A Randomized Phase II Trial of Decitabine-Based Induction Strategies for Patients >/= 60 Years Old With Acute Myeloid Leukemia (AML)

National Cancer Institute (NCI)·interventional·Posted Aug 22, 2011·Updated Feb 28, 2023

In Brief

A Phase 2 clinical trial evaluating Bortezomib, Decitabine, and 4 other interventions for Acute Myeloid Leukemia and 2 related conditions. Completed, enrolled 165 participants across 53 sites.

Detailed Summary

This randomized phase II trial studies how well giving decitabine with or without bortezomib works in treating older patients with acute myeloid leukemia. Drugs used in chemotherapy, such as decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells,by stopping them from dividing, or by stopping them from spreading. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. It is not yet known whether decitabine works better when given with or without bortezomib in treating acute myeloid leukemia.

Study Details

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

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedAug 22, 2011
Enrollment StartNov 16, 2011
Primary CompletionJun 5, 2016
Study CompletionApr 1, 2021
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 14.9 years ago

Interventions

Bortezomibdrug

Given SC

Decitabinedrug

Given IV

Laboratory Biomarker Analysisother

Correlative studies

Pharmacological Studyother

Correlative studies

Quality-of-Life Assessmentother

Ancillary studies

Questionnaire Administrationother

Ancillary studies