NCT01141725

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Fred Hutchinson Cancer Center · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• 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

Interventions

Type	Name	Description
DRUG	bendamustine hydrochloride	Given IV
DRUG	idarubicin	Given IV

Timeline

• Start date: 2010-09-01
• Primary completion: 2012-11-01
• Completion: 2012-11-01
• First posted: 2010-06-10
• Last updated: 2017-08-18
• Results posted: 2017-08-18

Locations

1 site across 1 country: United States