CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 39 enrolled
Drug / intervention
bendamustine hydrochloride +1 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/NCT01141725
NCT01141725Phase 2Completed
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Safety and Clinical Activity of Treanda® (Bendamustine HCL) and Idarubicin in Combination Therapy for Patients Age >= 50 With Previously Untreated Acute Myeloid Leukemia and High Risk Myelodysplastic Syndrome

Fred Hutchinson Cancer Center·interventional·Posted Jun 10, 2010·Updated Aug 18, 2017

In Brief

A Phase 2 clinical trial evaluating bendamustine hydrochloride and idarubicin for Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities and 8 related conditions. Completed, enrolled 39 participants across 1 site.

Detailed Summary

This phase I/II trial is studying the side effects and best dose of bendamustine hydrochloride when given together with idarubicin in treating older patients with previously untreated acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). Drugs used in chemotherapy, such as bendamustine hydrochloride or idarubicin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q), Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(15;17)(q22;q12), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), de Novo Myelodysplastic Syndromes, Myelodysplastic Syndrome With Isolated Del(5q), Untreated Adult Acute Myeloid Leukemia
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 10, 2010
Enrollment StartSep 1, 2010
Primary CompletionNov 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 16.1 years ago

Interventions

bendamustine hydrochloridedrug

Given IV

idarubicindrug

Given IV