At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 54 enrolled

Drug / intervention

Cytarabine +7 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/NCT01253070

NCT01253070Phase 2Completed

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A Phase II Study Incorporating Sorafenib (NSC 724772) Into the Therapy of Patients >/= 60 Years of Age With FLT3 Mutated Acute Myeloid Leukemia

National Cancer Institute (NCI)·interventional·Posted Dec 3, 2010·Updated Aug 4, 2022

In Brief

A Phase 2 clinical trial evaluating Biopsy, Bone Marrow Aspiration, and 6 other interventions for Acute Myeloid Leukemia With FLT3/ITD Mutation and 5 related conditions. Completed, enrolled 54 participants across 43 sites.

Detailed Summary

This phase II trial studies how well sorafenib tosylate and chemotherapy work in treating older patients with acute myeloid leukemia (AML). Sorafenib tosylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as daunorubicin hydrochloride and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving sorafenib tosylate and combination chemotherapy may be an effective treatment for AML.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsAcute Myeloid Leukemia With FLT3/ITD Mutation, Acute Myeloid Leukemia With Inv(16)(p13.1q22) or t(16;16)(p13.1;q22); CBFB-MYH11, Acute Myeloid Leukemia With t(8;21); (q22; q22.1); RUNX1-RUNX1T1, Acute Promyelocytic Leukemia With PML-RARA, FLT3 Gene Mutation, Therapy-Related Acute Myeloid Leukemia

CountriesUnited States

Collaborators--

Timeline

Phase 2CompletedFinished

2011201220132014201520162017201820192020202120222023202420252026

First PostedDec 2010

Enrollment StartApr 2011

Primary CompletionOct 2014

Study CompletionApr 2021

TodayJul 2026

First PostedDec 3, 2010

Enrollment StartApr 1, 2011

Primary CompletionOct 31, 2014

Study CompletionApr 15, 2021

TodayJul 2, 2026

Enrollment to primary: 3.6 yearsPosted 15.6 years ago

Interventions

Biopsyprocedure

Undergo biopsy

Bone Marrow Aspirationprocedure

Undergo bone marrow aspirate

Cytarabinedrug

Given IV

Daunorubicin Hydrochloridedrug

Given IV

Laboratory Biomarker Analysisother

Correlative studies

Quality-of-Life Assessmentother

Ancillary studies

Questionnaire Administrationother