Bendamustine Hydrochloride and Idarubicin in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia or Myelodysplastic Syndrome
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
Drug: bendamustine hydrochloride
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Maximum tolerated dose (MTD) of bendamustine hydrochloride (Phase I) [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]The highest dose level at which no more than one patient out of 6 experiences dose-limiting toxicities (DLT). DLT consists of grade 3-4 non-hematologic toxicity, with the exception of drug-related fever; alopecia; anorexia; inadequately treated nausea, vomiting, and/or diarrhea; and grade 3/4 increase in ALT, AST, or bilirubin that recovers to < grade 2 by 7 days.
- Response (Phase II) [ Time Frame: 6 months ] [ Designated as safety issue: No ]Assessed by cytogenetics/fluorescence in situ hybridization (FISH) and flow cytometry of blood and bone marrow samples. The response criteria defined by Cheson et al. will be used in this study. These criteria are: morphologic leukemia-free state; morphologic complete remission (CR); cytogenetic CR (CRc); molecular CR (CRm); morphologic CR with incomplete blood count recovery (CRi); partial remission (PR); treatment failure; recurrence (progressive disease).
- Incidence of greater than or equal to grade 3 toxicity [ Time Frame: Through day +100 after end of therapy or until the patient received an alternative treatment for leukemia, whatever happens earlier ] [ Designated as safety issue: Yes ]Toxicities will be graded using the National Cancer Institute (NCI) Common Toxicity Criteria version 3.0.
- Disease free survival (DFS) [ Time Frame: Over 5 years ] [ Designated as safety issue: No ]
- Overall survival (OS) [ Time Frame: Over 5 years ] [ Designated as safety issue: No ]
|Study Start Date:||September 2010|
|Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
Experimental: Treatment (combination chemotherapy)
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.
Drug: bendamustine hydrochloride
Other Names:Drug: idarubicin
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01141725
|United States, Washington|
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|
|Seattle, Washington, United States, 98109|
|Principal Investigator:||John Pagel||Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|