NCT00416598|CompletedPhase 2Results

Decitabine as Maintenance Therapy After Standard Therapy in Treating Patients With Previously Untreated Acute Myeloid Leukemia

Phase II Study of Maintenance Therapy With Decitabine (NSC #127716) Following Standard Induction and Cytogenetic Risk-Adapted Intensification in Previously Untreated Patients With AML < 60 Years

National Cancer Institute (NCI)ClinicalTrials.gov

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7 other identifiers

NCI-2009-00444CDR0000521603CALGB 10503CALGB-10503R21CA128377U10CA180821U10CA031946

Study Type

interventional

Target

546

Locations

1 country

Sites

Timeline

RegisteredDec 2006

StartedNov 2006

CompletionDec 2016

Brief Summary

This phase II trial is studying the side effects and how well decitabine works when given as maintenance therapy after standard therapy in treating patients with previously untreated acute myeloid leukemia. Drugs used in chemotherapy, such as cytarabine, daunorubicin, etoposide, busulfan, 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 decitabine as maintenance therapy after standard therapy may keep cancer cells from coming back.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

546

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Nov 2006

Longer than P75 for phase_2

Geographic Reach

1 country

46 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

10.1 years study duration

Study Start

First participant enrolled

November 15, 2006

Completed

1 month until next milestone

First Submitted

Initial submission to the registry

December 27, 2006

Completed

1 day until next milestone

First Posted

Study publicly available on registry

December 28, 2006

Completed

4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2011

Completed

3.1 years until next milestone

Results Posted

Study results publicly available

February 20, 2014

Completed

2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed

Last Updated

February 19, 2019

Status Verified

January 1, 2019

Enrollment Period

4.2 years

First QC Date

December 27, 2006

Results QC Date

January 6, 2014

Last Update Submit

January 29, 2019

Conditions

Acute Myeloid Leukemia Acute Myeloid Leukemia With Myelodysplasia-Related Changes Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11 Adult Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11 Adult Acute Myeloid Leukemia With t(8;21); (q22; q22.1); RUNX1-RUNX1T1 Adult Acute Myeloid Leukemia With t(9;11)(p22.3;q23.3); MLLT3-KMT2A Untreated Adult Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (2)

Number of Participants Who Completed Maintenance Decitabine.
To determine feasibility of decitabine maintenance, this outcome measures the number of participants who completed all 8 planned cycles of decitabine maintenance as per protocol.
Up to 5 years
Disease-free Survival (DFS) Rate at 1 Year
For participants who achieved a complete remission (CR), this is the percentage of participants who were alive and relapse free at 1 year. The 1 year rate, with 95% confidence interval, was estimated using the Kaplan-Meier method A CR is defined as those with \> 20% cellularity of bone marrow biopsy, no presence of extramedullary leukemia for AML, \<5 % myeloblast cells for bone marrow with peripheral blood and normal complete blood count (absolute neutrophils \> 1000 mL and platelets \>= 100,000 mL).
At 1 year

Other Outcomes (1)

Relationship Between Busulfan Pharmacokinetics (Area Under the Curve) and Relapsed Disease
At baseline, after 2, 4, and 6 hours after the start of busulfan infusion

Study Arms (1)

Treatment (chemotherapy, PBSC or bone marrow transplantation)

EXPERIMENTAL

See Detailed Description.

Procedure: Autologous Bone Marrow TransplantationProcedure: Autologous Hematopoietic Stem Cell TransplantationDrug: BusulfanDrug: CytarabineDrug: Daunorubicin HydrochlorideDrug: DecitabineDrug: EtoposideBiological: FilgrastimOther: Laboratory Biomarker AnalysisOther: Pharmacological Study