Plerixafor and Clofarabine in Frontline Treatment of Elderly Patients With Acute Myelogenous Leukemia (AML)
The goal of Part 1 of this clinical research study is to learn about the safety of the combination of plerixafor and clofarabine when given to patients with previously untreated AML who are at least 60 years old.
The goal of Part 2 of this study is to learn if the combination of plerixafor and clofarabine can help to control previously untreated AML in patients who are at least 60 years old.
Acute Myelogenous Leukemia
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I/II Study of Plerixafor and Clofarabine in Previously Untreated Older (>/=60 Years) Adult Patients With Acute Myelogenous Leukemia (AML) With Two or More Unfavorable Prognostic Factors for Whom Standard Induction Chemotherapy is Unlikely to be of Benefit|
- Number of Participants in Phase I with First Cycle Dose Limiting Toxicities (DLT) Observed [ Time Frame: First cycle of treatment, i.e. first 4 weeks on study ] [ Designated as safety issue: Yes ]Dose limiting toxicity (DLT) consists of participants who developed DLT during maximum tolerated dose (MTD) estimation period or who completed the MTD estimation period without DLTs. DLTs observed during dose escalation used to develop MTD.
- Number of Participants with Overall Response during Phase II [ Time Frame: Continuously monitored, assessments at 12 weeks ] [ Designated as safety issue: Yes ]Overall response (OR) = Complete Remission (CR) + Partial Remission (PR)
|Study Start Date:||August 2010|
|Estimated Primary Completion Date:||August 2017 (Final data collection date for primary outcome measure)|
Experimental: Plerixafor + Clofarabine
Phase I: Plerixafor starting at 240 mcg/kg daily subcutaneous (SQ) injection on Days 1-5, 4-6 hours before a 1 hour (+/- 30 minutes) IV administration of Clofarabine.
Phase II: Plerixafor at the highest dose tolerated in Phase I.
Phase I and II: Clofarabine fixed dose of 30 mg/m2/day during Induction cycle (20 mg/m2/day in consolidation cycles).
Starting at 240 mcg/kg daily subcutaneous (SQ) injection on Days 1-5, 4-6 hours before a 1 hour (+/- 30 minutes) IV administration of Clofarabine
Other Name: MobozilDrug: Clofarabine
Fixed dose of 30 mg/m2/day during Induction cycle (20 mg/m2/day in consolidation cycles).
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01160354
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Study Chair:||Jan A. Burger, MD||M.D. Anderson Cancer Center|