CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 37 enrolled
Drug / intervention
Azacitidine +2 moredrug
Likely dose
Azacitidine 75 mg/m2from 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/NCT01743859
NCT01743859Phase 2Completed
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Sequential Treatment With Azacitidine and Lenalidomide for Relapsed and Refractory Patients With Acute Myeloid Leukemia

University of Colorado, Denver·interventional·Posted Dec 6, 2012·Updated Oct 8, 2019

In Brief

A Phase 2 clinical trial evaluating Azacitidine, Lenalidomide, and 1 other intervention for Acute Myeloid Leukemia. Completed, enrolled 37 participants across 1 site.

Detailed Summary

The primary objective of this study is to determine the complete remission/complete remission with incomplete recovery of blood counts (CR/CRi) rate for relapsed and refractory acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS) patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Myeloid Leukemia
CountriesUnited States
CollaboratorsCelgene

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedDec 6, 2012
Enrollment StartDec 6, 2012
Primary CompletionApr 27, 2016
Study CompletionAug 3, 2016
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 13.6 years ago

Interventions

Azacitidinedrug

Enrolled patients will receive 75 mg/m2 of azacitidine subcutaneously (SC) or intravenously (IV) on days 1-7 alone.

Lenalidomidedrug

Beginning on day 8, patients will receive 50 mg of lenalidomide PO, and will take this daily from day 8 through 28.

Off Therapyother

2 weeks off therapy, then begin sequence again for 12 weeks.