CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 754 enrolled
Drug / intervention
Cytarabine +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/NCT01802333
NCT01802333Phase 3Completed

A Randomized Phase III Study of Standard Cytarabine Plus Daunorubicin (7+3) Therapy or Idarubicin With High Dose Cytarabine (IA) Versus IA With Vorinostat (NSC-701852) (IA + V) in Younger Patients With Previously Untreated Acute Myeloid Leukemia (AML)

National Cancer Institute (NCI)·interventional·Posted Mar 1, 2013·Updated Dec 19, 2018

In Brief

A Phase 3 clinical trial evaluating Allogeneic Hematopoietic Stem Cell Transplantation, Cytarabine, and 4 other interventions for Acute Myeloid Leukemia and Untreated Adult Acute Myeloid Leukemia. Completed, enrolled 754 participants across 447 sites in 2 countries.

Detailed Summary

This randomized phase III trial studies cytarabine and daunorubicin hydrochloride or idarubicin and cytarabine with or without vorinostat to see how well they work in treating younger patients with previously untreated acute myeloid leukemia. Drugs used in chemotherapy, such as cytarabine, daunorubicin hydrochloride, idarubicin, and vorinostat, work in different ways to stop the growth of cancer cells, either by killing the cells, stopping them from dividing, or by stopping from spreading. Giving more than one drug (combination chemotherapy) and giving the drugs in different doses and in different combinations may kill more cancer cells. It is not yet known which combination chemotherapy is more effective in treating acute myeloid leukemia.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMar 1, 2013
Enrollment StartFeb 12, 2013
Primary CompletionJun 15, 2017
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 13.3 years ago

Interventions

Allogeneic Hematopoietic Stem Cell Transplantationprocedure

Undergo allogeneic transplant

Cytarabinedrug

Given IV

Daunorubicin Hydrochloridedrug

Given IV

Idarubicindrug

Given IV

Laboratory Biomarker Analysisother

Correlative studies

Vorinostatdrug

Given PO