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Bendamustine Hydrochloride and Idarubicin in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia or Myelodysplastic Syndrome

Information source: Fred Hutchinson Cancer Research Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities; Adult Acute Myeloid Leukemia With Del(5q); Adult Acute Myeloid Leukemia With Inv(16)(p13;q22); Adult Acute Myeloid Leukemia With t(15;17)(q22;q12); Adult Acute Myeloid Leukemia With t(16;16)(p13;q22); Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); de Novo Myelodysplastic Syndromes; Myelodysplastic Syndrome With Isolated Del(5q); Untreated Adult Acute Myeloid Leukemia

Intervention: bendamustine hydrochloride (Drug); idarubicin (Drug)

Phase: Phase 1/Phase 2

Status: Completed

Sponsored by: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Official(s) and/or principal investigator(s):
John Pagel, Principal Investigator, Affiliation: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

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

Clinical Details

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

Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Maximum tolerated dose (MTD) of bendamustine hydrochloride (Phase I)

Response (Phase II)

Incidence of greater than or equal to grade 3 toxicity

Secondary outcome:

Disease free survival (DFS)

Overall survival (OS)

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.

Eligibility

Minimum age: 50 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium, Seattle, Washington 98109, United States
Additional Information

Starting date: September 2010
Last updated: December 7, 2012

Page last updated: August 23, 2015

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