NCT01420926|CompletedPhase 2Results

Decitabine With or Without Bortezomib in Treating Older Patients With Acute Myeloid Leukemia

A Randomized Phase II Trial of Decitabine-Based Induction Strategies for Patients >/= 60 Years Old With Acute Myeloid Leukemia (AML)

National Cancer Institute (NCI)ClinicalTrials.gov

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5 other identifiers

NCI-2011-02987CDR0000709218CALGB-11002U10CA180821U10CA031946

Study Type

interventional

Target

165

Locations

1 country

Sites

Timeline

RegisteredAug 2011

StartedNov 2011

CompletionApr 2021

Brief Summary

This randomized phase II trial studies how well giving decitabine with or without bortezomib works in treating older patients with acute myeloid leukemia. Drugs used in chemotherapy, such as decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells,by stopping them from dividing, or by stopping them from spreading. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. It is not yet known whether decitabine works better when given with or without bortezomib in treating acute myeloid leukemia.

Trial Health

On Track

Trial Health Score

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

Enrollment

165

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Nov 2011

Longer than P75 for phase_2

Geographic Reach

1 country

53 active sites

Status

completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

9.4 years study duration

First Submitted

Initial submission to the registry

August 19, 2011

Completed

3 days until next milestone

First Posted

Study publicly available on registry

August 22, 2011

Completed

3 months until next milestone

Study Start

First participant enrolled

November 16, 2011

Completed

4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2016

Completed

5 months until next milestone

Results Posted

Study results publicly available

October 24, 2016

Completed

4.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed

Last Updated

February 28, 2023

Status Verified

February 1, 2023

Enrollment Period

4.6 years

First QC Date

August 19, 2011

Results QC Date

August 30, 2016

Last Update Submit

February 2, 2023

Conditions

Acute Myeloid Leukemia Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome Therapy-Related Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

Overall Survival (OS) Time
Overall survival (OS) was defined as the time from study entry to death of any cause. Surviving patients were censored at the date of last follow-up. The median OS with 95% CI was estimated using the Kaplan Meier method.
48 months

Secondary Outcomes (4)

Complete Remission Rate (CR and CRi)
48 months
Disease-free Survival (DFS)
48 months
Progression-free Survival
48 months
Adverse Events
48 months

Study Arms (2)

Arm A (decitabine)

EXPERIMENTAL

REMISSION INDUCTION THERAPY: Patients receive 20 mg/m\^2 decitabine IV over 1 hour QD on days 1-10. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy. CONTINUATION THERAPY: Patients receive 20 mg/m\^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive 20 mg/m\^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Drug: DecitabineOther: Laboratory Biomarker AnalysisOther: Pharmacological StudyOther: Quality-of-Life AssessmentOther: Questionnaire Administration

Arm B (decitabine and bortezomib)

EXPERIMENTAL

REMISSION INDUCTION THERAPY: Patients receive 20 mg/m\^2 decitabine IV over 1 hour QD on days 2-11 and 1.3 mg/m\^2 bortezomib SC on days 1, 4, 8, and 11. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy. CONTINUATION THERAPY: Patients receive 1.3 mg/m\^2 bortezomib SC on day 1 and 20 mg/m\^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive 1.3 mg/m\^2 bortezomib SC on day 1 and 20 mg/m\^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Drug: BortezomibDrug: DecitabineOther: Laboratory Biomarker AnalysisOther: Pharmacological StudyOther: Quality-of-Life AssessmentOther: Questionnaire Administration

Interventions

BortezomibDRUG

Given SC

Also known as: [(1R)-3-Methyl-1-[[(2S)-1-oxo-3-phenyl-2-[(pyrazinylcarbonyl)amino]propyl]amino]butyl]boronic Acid, LDP 341, MLN341, PS-341, PS341, Velcade

Arm B (decitabine and bortezomib)

DecitabineDRUG

Given IV

Also known as: 5-Aza-2'-deoxycytidine, Dacogen, Decitabine for Injection, Deoxyazacytidine, Dezocitidine