Study Stopped
Withdrawal of support from sponsor
IV Plerixafor With Mitoxantrone Etoposide and Cytarabine for Acute Myeloid Leukemia (AML)
AML
A Phase I Study of Intravenous Plerixafor in Combination With Mitoxantrone Etoposide and Cytarabine for Relapsed or Refractory Acute Myeloid Leukemia
1 other identifier
interventional
6
1 country
1
Brief Summary
In this phase I extension study, the investigators seek to test the safety of both higher doses of plerixafor as well as intravenous dosing to maximize inhibition of the target, CXCR4.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started May 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 7, 2009
CompletedFirst Posted
Study publicly available on registry
December 9, 2009
CompletedStudy Start
First participant enrolled
May 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedJanuary 26, 2015
January 1, 2015
2 months
December 7, 2009
January 21, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
To determine the maximum tolerated dose and dose limiting toxicities of intravenous plerixafor when combined with MEC in patients with relapsed or refractory AML.
Days 1-42 (all patients have to complete)
Secondary Outcomes (10)
To determine the complete response rate (CR) for plerixafor when combined with MEC in patients with relapsed or refractory AML.
Between days 15-42
To determine the safety and tolerability of plerixafor in combination with MEC
Minimum of 30 days following completion of treatment
To determine the PK and explore potential PK drug-drug interactions between plerixafor and MEC.
Predose, 15 min, 30 min , and 10 hrs
To determine the time to hematologic recovery
For up to 2 years
To characterize the mobilization of leukemic cells with plerixafor plus G-CSF.
Baseline, 6 hours
- +5 more secondary outcomes
Study Arms (3)
Dose Level 1
EXPERIMENTALMitoxantrone 8 mg/m2/day IV over 30 minutes once daily on days 1-5 Plerixafor 320 mcg/kg/day IV over 30 minutes on days 0-5 Etoposide 100 mg/m2/day IV over 60 minutes once daily on days 1-5 Cytarabine 1000 mg/m2/day IV over 60 minutes once daily on days 1-5
Dose Level 2
EXPERIMENTALMitoxantrone 8 mg/m2/day IV over 30 minutes once daily on days 1-5 Plerixafor 420 mcg/kg/day IV over 30 minutes on days 0-5 Etoposide 100 mg/m2/day IV over 60 minutes once daily on days 1-5 Cytarabine 1000 mg/m2/day IV over 60 minutes once daily on days 1-5
Dose Level 3
EXPERIMENTALMitoxantrone 8 mg/m2/day IV over 30 minutes once daily on days 1-5 Plerixafor 560 mcg/kg/day IV over 30 minutes on days 0-5 Etoposide 100 mg/m2/day IV over 60 minutes once daily on days 1-5 Cytarabine 1000 mg/m2/day IV over 60 minutes once daily on days 1-5
Interventions
Eligibility Criteria
You may qualify if:
- Acute myeloid leukemia diagnosed according to WHO criteria with one of the following:
- Primary refractory disease following ≥ 1 round of induction chemotherapy
- First relapse or higher
- Age between 18 and 70 years
- ECOG performance status ≤ 2
- Adequate organ function defined as:
- Creatinine ≤ 1.5 x institutional ULN
- AST ≤ 2 x ULN except when in the opinion of treating physician is due to direct involvement of leukemia (e.g., hepatic infiltration or biliary obstruction due to leukemia)
- ALT ≤ 2 x ULN except when in the opinion of treating physician is due to direct involvement of leukemia (e.g., hepatic infiltration or biliary obstruction due to leukemia)
- Total bilirubin ≤ 2 x ULN except when in the opinion of treating physician is due to direct involvement of leukemia (e.g., hepatic infiltration or biliary obstruction due to leukemia)
- Left ventricular ejection fraction of ≥ 40% by MUGA scan or echocardiogram
- Women of childbearing potential and sexually active males must be willing and able to use effective contraception while on study
- Able to provide signed informed consent prior to registration on study
You may not qualify if:
- Acute promyelocytic leukemia (AML with t(15;17)(q22;q11) and variants)
- Peripheral blood blast count ≥ 50 x 103 /mm3
- Active CNS involvement with leukemia
- Previous treatment with MEC or other regimen containing both mitoxantrone and etoposide
- Pregnant or nursing
- Concurrently receiving any other investigational agent
- Received colony stimulating factors filgrastim or sargramostim within 48 hours or pegfilgrastim within 14 days of study
- Less than 2 weeks from the completion of any previous cytotoxic chemotherapy (excluding hydroxyurea)
- Severe concurrent illness that would limit compliance with study requirements
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Geoffrey Uy, M.D.
Washington University School of Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 7, 2009
First Posted
December 9, 2009
Study Start
May 1, 2010
Primary Completion
July 1, 2010
Study Completion
September 1, 2011
Last Updated
January 26, 2015
Record last verified: 2015-01