CClinicalTrials.gg
TerminatedNCT01465386Updated Apr 4, 2017Results posted

Bortezomib in Treating Patients With High-Risk Acute Myeloid Leukemia in Remission

A Phase 2 interventional study of bortezomib in Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome, Adult Acute Minimally Differentiated Myeloid Leukemia (M0) and Adult Acute Myeloblastic Leukemia Without Maturation (M1), sponsored by Fred Hutchinson Cancer Center. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-04-04.

Sponsored by Fred Hutchinson Cancer Center · Phase 2, Interventional, and Treatment

Why this study was terminated
Closed early due to slow enrollment
Phase
Phase 2
Study type
Interventional
Enrollment
6
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This phase II trial studies how well bortezomib works in treating patients with high-risk acute myeloid leukemia (AML) in remission. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth

Read the detailed description

PRIMARY OBJECTIVES:

I. To determine if bortezomib when given as maintenance therapy for six months post-remission can improve the progression-free survival (PFS) rate by 50% (or 4.5 months) in first remission patients with high-risk AML.

SECONDARY OBJECTIVES:

I. To determine the overall survival (OS) after maintenance therapy with bortezomib in first remission AML patients.

II. To assess the safety and tolerability of subcutaneous (SC) administration of bortezomib given as maintenance therapy to first remission AML patients.

OUTLINE:

Patients receive bortezomib SC on days 1, 8, 15 and 22. Treatment repeats every 35 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 4 weeks, every 3 months for 2 years, and then annually for 3 years.

02

Conditions studied

  • Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome
  • Adult Acute Minimally Differentiated Myeloid Leukemia (M0)
  • Adult Acute Myeloblastic Leukemia Without Maturation (M1)
  • Adult Acute Myeloid Leukemia in Remission
  • Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
  • Adult Acute Myeloid Leukemia With Del(5q)
  • Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
  • Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
  • Adult Acute Promyelocytic Leukemia (M3)
  • Adult Erythroleukemia (M6a)
  • Adult Pure Erythroid Leukemia (M6b)
  • Secondary Acute Myeloid Leukemia
03

In context

Leukemia

5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.

This study's enrollment of 6 is below the median of 38 across 4,247 interventional studies indexed under Leukemia.

Browse Leukemia studies →

Lead sponsor

Fred Hutchinson Cancer Center is the lead sponsor of 537 studies on the registry; 79 are open to participants now.

Of its 57 completed or terminated interventional studies of FDA-regulated products, 45 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • All adults with first remission AML including those with prior myelodysplasia (MDS)/AML, therapy-related AML, AML with trilineage dysplasia (AML-TLD), and AML with adverse cytogenetics
  • History of histopathologically documented AML that is currently in first remission with the presence of 5% or less blasts by morphology and/or flow cytometry from a bone marrow aspirate and/or biopsy obtained within 14 days of enrollment
  • Patients must start therapy between 3-8 weeks after receiving their last prior therapy (either induction therapy or consolidation therapy)
  • Patients may receive up to 4 courses of remission consolidation therapy (e.g., cytarabine) prior to enrollment
  • Normal kidney and liver function with serum creatinine =\< 2.0 mg/dl
  • Total bilirubin =\< 1.5 upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2.5 x ULN
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  • Male subjects, even if surgically sterilized (i.e., status postvasectomy) must agree to 1 of the following: practice effective barrier contraception during the entire study treatment period and through a minimum of 30 days after the last dose of study drug, or completely abstain from heterosexual intercourse
  • Female subject is either postmenopausal for at least 1 year before the screening visit, is surgically sterilized or if they are of childbearing potential, agree to practice 2 effective methods of contraception from the time of signing the informed consent form through 30 days after the last dose of bortezomib, or agree to completely abstain from heterosexual intercourse
  • Understand and voluntarily sign the informed consent form for this study

Exclusion criteria

Exclusion Criteria:

  • Favorable AML features defined as the following:

    • t(8;21)(q22;q22); RUNX1-RUNX1T1
    • inv(16)(p13.1q22) or t(16;16)(p13.1;q22); CBFB-MYH11
    • Mutated NPM1 without FLT3-ITD (normal karyotype)
    • Mutated CEBPA (normal karyotype)
  • Persistent clinically significant non-hematological toxicity that is > Grade 1 by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4 from prior chemotherapy
  • Active uncontrolled infection
  • Known infection with human immunodeficiency virus (HIV)
  • Medical condition, serious concurrent illness, or other extenuating circumstance that, in the judgment of the Principal Investigator, could jeopardize patient safety or interfere with the objectives of the study
  • Uncontrolled or significant cardiovascular disease, including:

    • Uncontrolled angina or myocardial infarction within 6 months
    • Current or history of congestive heart failure New York Heart Association (NYHA) class 3 or 4, unless a screening echocardiogram (ECHO) or Multiple Gate Acquisition Scan (MUGA) performed within 1 month prior to study screening results in a left ventricular ejection fraction (LVEF) that is >= 45% (or institutional lower limit of normal value)
    • Prolonged QTc interval (> 450 msec)
  • Diagnosed or treated for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy
  • Patient has a platelet count of \< 30,000 within 3 days before enrollment
  • Patient has an absolute neutrophil count of \< 300 within 3 days before enrollment
  • Patient has >= Grade 2 peripheral neuropathy
  • Patient has hypersensitivity to bortezomib, boron, or mannitol
  • Female patients who are lactating or have a positive urine pregnancy test during the screening; pregnancy testing is not required for postmenopausal or surgically sterilized women
  • Participation in clinical trials with other investigational agents not included in this trial, within 14 days of the start of this trial and throughout the duration of this trial
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
6 participants (actual)

Study arms

  • Experimental
    Treatment (enzyme inhibitor therapy)

    Patients receive bortezomib SC on days 1, 8, 15 and 22. Treatment repeats every 35 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

    Drug: bortezomib

Interventions

  • Drugbortezomib

    Given SC

    Also known as: LDP 341, MLN341, VELCADE

06

What researchers measure

Primary outcomes

  1. Progression Free Survival (PFS)

    Number of days from enrollment to recurrence of acute myeloid leukemia as determined by the reappearance of blasts in the blood or marrow

    Time frame: Up to 2 years

07

Results

Posted Apr 4, 2017
Limitations and caveats
Difficulty finding patients willing or available to come in to clinic for weekly injections for the duration of the study. Study was ultimately closed because of slow enrollment.

Participant flow

Participant flow — Overall Study
MilestoneTreated Patients
Started6
Completed2
Not completed4
Withdrew: Lack of efficacy3
Withdrew: Adverse event1

Outcome measures

PrimaryProgression Free Survival (PFS)

Number of days from enrollment to recurrence of acute myeloid leukemia as determined by the reappearance of blasts in the blood or marrow

Time frame:
Up to 2 years
Reported as:
Median · days
Progression Free Survival (PFS)
daysTreated Patients
Progression Free Survival (PFS)107 (14 to 575)

Adverse events

Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Treatment (Enzyme Inhibitor Therapy)5/6 (83.3%)2/6 (33.3%)1/6 (16.7%)
Most frequent serious events
Most frequent serious events
EventTreatment (Enzyme Inhibitor Therapy)
Altered Mental StatusNervous system disorders1/6
CholechystitisGastrointestinal disorders1/6
Most frequent other events
Most frequent other events
EventTreatment (Enzyme Inhibitor Therapy)
Peripheral neuropathyNervous system disorders1/6

Baseline characteristics

Age, Continuous
Age, Continuous(years)Treatment (Enzyme Inhibitor Therapy)
Median78 (61 to 87)
Sex: Female, Male
Sex: Female, Male(Participants)Treatment (Enzyme Inhibitor Therapy)
Female3
Male3
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Treatment (Enzyme Inhibitor Therapy)
Hispanic or Latino0
Not Hispanic or Latino6
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Treatment (Enzyme Inhibitor Therapy)
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American1
White5
More than one race0
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(participants)Treatment (Enzyme Inhibitor Therapy)
United States6
08

Study locations

1 site
  • Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
    Seattle, Washington 98109, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 4, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01465386
Lead sponsor
Fred Hutchinson Cancer Center
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Nov 4, 2011
Start date
Nov 2011
Primary completion
Jan 28, 2014
Completion
Mar 2, 2015
Results posted
Apr 4, 2017
Last update
Apr 4, 2017

Study contacts

John Pagel
principal investigator · Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion