CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 727 enrolled
Drug / intervention
Daunorubicin +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/NCT02085408
NCT02085408Phase 3Completed
CompareCT.gov

Phase III Randomized Trial of Clofarabine as Induction and Post-Remission Therapy vs. Standard Daunorubicin &Amp; Cytarabine Induction and Intermediate Dose Cytarabine Post-Remission Therapy, Followed by Decitabine Maintenance vs. Observation in Newly-Diagnosed Acute Myeloid Leukemia in Older Adults (Age >/= 60 Years)

ECOG-ACRIN Cancer Research Group·interventional·Posted Mar 12, 2014·Updated Dec 13, 2024

In Brief

A Phase 3 clinical trial evaluating Daunorubicin, Cytarabine, and 4 other interventions for Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome and 16 related conditions. Completed, enrolled 727 participants across 269 sites in 3 countries.

Detailed Summary

This randomized phase III trial studies clofarabine to see how well it works compared with daunorubicin hydrochloride and cytarabine when followed by decitabine or observation in treating older patients with newly diagnosed acute myeloid leukemia. Drugs used in chemotherapy, such as clofarabine, daunorubicin hydrochloride, cytarabine, and decitabine, 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. It is not yet known which chemotherapy regimen is more effective in treating acute myeloid leukemia.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome, Adult Acute Megakaryoblastic Leukemia (M7), Adult Acute Minimally Differentiated Myeloid Leukemia (M0), Adult Acute Monoblastic Leukemia (M5a), Adult Acute Monocytic Leukemia (M5b), Adult Acute Myeloblastic Leukemia With Maturation (M2), Adult Acute Myeloblastic Leukemia Without Maturation (M1), Adult 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(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), Adult Acute Myelomonocytic Leukemia (M4), Adult Erythroleukemia (M6a), Adult Pure Erythroid Leukemia (M6b), Secondary Acute Myeloid Leukemia, Untreated Adult Acute Myeloid Leukemia
CountriesIndia, Israel, United States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 12, 2014
Enrollment StartFeb 4, 2011
Primary CompletionFeb 22, 2021
Study CompletionDec 21, 2022
TodayJul 2, 2026
Enrollment to primary: 10.0 yearsPosted 12.3 years ago

Interventions

Daunorubicindrug

Given IV

Cytarabinedrug

Given IV

Clofarabinedrug

Given IV

Decitabinedrug

Given IV

Observationother

Undergo clinical observation

Allogeneic hematopoietic stem cell transplantationprocedure

Patients with an HLA-identical donor proceed to allogeneic stem cell transplantation.