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

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Brief Title

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

Official Title

A Phase II Study of Subcutaneous Bortezomib as Maintenance Therapy for Patients With High-risk Acute Myeloid Leukemia in Remission

Brief 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
    

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.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Progression Free Survival (PFS)


Condition

Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome

Intervention

bortezomib

Study Arms / Comparison Groups

 Treatment (enzyme inhibitor therapy)
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

6

Start Date

November 2011

Completion Date

March 2, 2015

Primary Completion Date

January 28, 2014

Eligibility Criteria

        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:

          -  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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

John Pagel, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01465386

Organization ID

2529.00

Secondary IDs

NCI-2011-03115

Responsible Party

Sponsor

Study Sponsor

Fred Hutchinson Cancer Research Center

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

John Pagel, Principal Investigator, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium


Verification Date

February 2017