Bendamustine and Idarubicin in Treating Older Patients With Previously Untreated AML or MDS

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Brief Title

Bendamustine and Idarubicin in Treating Older Patients With Previously Untreated AML or MDS

Official Title

Safety and Clinical Activity of Treanda® (Bendamustine HCL) and Idarubicin in Combination Therapy for Patients Age >= 50 With Previously Untreated Acute Myeloid Leukemia and High Risk Myelodysplastic Syndrome

Brief Summary

      This phase I/II trial is studying the side effects and best dose of bendamustine
      hydrochloride when given together with idarubicin in treating older patients with previously
      untreated acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). Drugs used in
      chemotherapy, such as bendamustine hydrochloride or idarubicin, 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
    

Detailed Description

      PRIMARY OBJECTIVES:

      I. The maximum tolerated dose (MTD) that is associated with a complete remission (CR) rate of
      at least 40%, and a rate of grade 3-4 extramedullary toxicity < 30% in patients aged 50 or
      older with previously untreated AML or high-risk MDS.

      SECONDARY OBJECTIVES:

      I. The disease-free survival (DFS), and overall survival (OS) after therapy at each level of
      the dosing strategy.

      OUTLINE: This is a phase I, dose-escalation study of bendamustine hydrochloride followed by a
      phase II study.

      Patients receive bendamustine hydrochloride intravenously (IV) on days 1-5 and idarubicin IV
      on days 1 and 2. Treatment repeats every 28 days for up to 3 courses in the absence of
      disease progression or unacceptable toxicity.

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

Study Phase

Phase 1/Phase 2

Study Type

Interventional


Primary Outcome

Response

Secondary Outcome

 Disease-free Survival (DFS)

Condition

Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities

Intervention

bendamustine hydrochloride

Study Arms / Comparison Groups

 Treatment (combination chemotherapy)
Description:  Patients receive bendamustine hydrochloride IV on days 1-5 and idarubicin IV on days 1 and 2. Treatment repeats every 28 days for up to 3 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

39

Start Date

September 2010

Completion Date

November 2012

Primary Completion Date

November 2012

Eligibility Criteria

        Inclusion Criteria:

          -  Diagnosis of untreated AML or MDS with 10-19% marrow blasts; patients may be enrolled
             if they received prior treatment with demethylating agents specifically for the
             purpose of treating MDS or if they have received a single dose of cytarabine for the
             control of symptoms related to AML

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2

          -  Serum creatinine =< 2.0 mg/dL; if serum creatinine > 2.0 mg/dL, then the estimated
             glomerular filtration rate (GFR) must be > 50 mL/min/1.73 m^2 as calculated by the
             Modification of Diet in Renal Disease equation

          -  Serum bilirubin =< 1.5 x upper limit of normal (ULN)

          -  Aspartate transaminase (AST)/alanine transaminase (ALT) =< 2.5 x ULN

          -  Alkaline phosphatase =< 2.5 x ULN

          -  Capable of understanding the investigational nature, potential risks and benefits of
             the study, and able to provide valid informed consent

          -  Males should be willing to use an effective contraceptive method during the study and
             for a minimum of 6 months after study treatment

          -  Women must be postmenopausal or must be willing to use an acceptable method of
             contraception to avoid pregnancy for the entire period of the study and for at least 3
             months after the study; a postmenopausal woman is defined as a woman who has
             experienced amenorrhea > 12 consecutive months or a woman on hormone replacement
             therapy with documented follicle-stimulating hormone (FSH) level > 35 mIU/mL; for
             patients in whom menopausal state is in question, a negative pregnancy test will be
             required prior to enrollment

        Exclusion Criteria:

          -  Current concomitant chemotherapy, radiation therapy, or immunotherapy other than as
             specified in the protocol

          -  Use of investigational agents within 30 days or any anticancer therapy within 2 weeks
             before study entry with the exception of hydroxyurea or single-dose cytarabine;
             subjects who are enrolled with high risk MDS (specifically) may have prior treatment
             with drugs in the class called "demethylating agents"; examples of these drugs include
             5-azacytidine (azacitidine) and 5-azadeoxycytidine (decitabine), and may include
             approved or experimental drugs not currently used, which fall into this class and may
             be developed in the future; the patient must have recovered from all acute toxicities
             from any previous therapy

          -  Have any other severe concurrent disease, or have a history of serious organ
             dysfunction or disease involving the heart, kidney, liver, or other organ system that
             may place the patient at undue risk to undergo treatment

          -  Patients with a systemic fungal, bacterial, viral, or other infection not controlled
             (defined as exhibiting ongoing signs/symptoms related to the infection and without
             improvement, despite appropriate antibiotics or other treatment)

          -  Pregnant or lactating patients

          -  Any significant concurrent disease, illness, or psychiatric disorder that would
             compromise patient safety or compliance, interfere with consent, study participation,
             follow up, or interpretation of study results

          -  Known hypersensitivity to bendamustine (bendamustine hydrochloride) or idarubicin

          -  Clinical evidence suggestive of central nervous system (CNS) involvement with leukemia
             unless a lumbar puncture confirms the absence of leukemic blasts in the cerebrospinal
             fluid (CSF)

          -  Have had a diagnosis of another malignancy, unless the patient has been disease-free
             for at least 3 years following the completion of curative intent therapy

          -  Other circumstances in which patients with prior malignancies are not excluded,
             include the following:

               -  Patients with treated non-melanoma skin cancer, in situ carcinoma, or cervical
                  intraepithelial neoplasia, regardless of the disease-free duration, if definitive
                  treatment for the condition has been completed

               -  Patients with organ-confined prostate cancer with no evidence of recurrent or
                  progressive disease based on prostate-specific antigen (PSA) values if hormonal
                  therapy has been initiated, or a radical prostatectomy or definitive radiotherapy
                  has been performed

               -  Concurrent hormonal therapy is allowed
      

Gender

All

Ages

50 Years - N/A

Accepts Healthy Volunteers

No

Contacts

John Pagel, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01141725

Organization ID

2413.00

Secondary IDs

NCI-2010-01253

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

July 2017