POETIC Plerixafor as a Chemosensitizing Agent for Relapsed Acute Leukemia and MDS in Pediatric Patients
A Phase I Study Using Plerixafor as a Chemosensitizing Agent for Relapsed Acute Leukemia and MDS in Pediatric Patients
2 other identifiers
interventional
20
2 countries
9
Brief Summary
In this Phase I study, we will test the safety of the drug plerixafor (MOBOZIL) at different dose levels, used together with other anti-cancer drugs-cytarabine and etoposide. We want to find out what effects, good and /or bad, this combination of drugs has on leukemia. Plerixafor is a drug that blocks a receptor on the leukemia cell, which prevents it from staying in the bone marrow where it can be resistant to chemotherapy. Plerixafor is FDA approved for mobilizing stem cells from the bone marrow in preparation for an autologous stem cell transplant. Cytarabine and etoposide have been used as part of standard chemotherapy for ALL and AML. However, the use of plerixafor with cytarabine and etoposide in pediatric patients with relapsed or refractory ALL, AML and MDS is considered experimental.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Mar 2011
Longer than P75 for phase_1
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 11, 2011
CompletedFirst Posted
Study publicly available on registry
March 22, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 28, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 28, 2016
CompletedSeptember 7, 2018
September 1, 2018
2.3 years
March 11, 2011
September 5, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Maximum Tolerated Dose (MTD) of Plerixafor given in combination with chemotherapy
To determine the safety and tolerability of plerixafor in combination with reinduction chemotherapy in pediatric and young adult patients with relapsed/refractory acute leukemia (AML/MDS and ALL)
6 months post final enrollment
Secondary Outcomes (7)
Response Rate
6 months post completion of treatment for final enrollment
Measure Peak Plasma Concentration (Cmax) of Plerixafor using serial peripheral blood sampling
12 months following last sample collection
Leukemic blast mobilization
12 months after final sample collection
CXCR4 expression on leukemic blasts
12 months after last patient completes therapy
Measure Area Under the Concentration-Time Curve (AUC) of Plerixafor using serial peripheral blood sampling
12 months following last sample collection
- +2 more secondary outcomes
Study Arms (1)
Plerixafor, Dose Escalation
EXPERIMENTALDose escalation of plerixafor administered intravenously in combination with IV cytarabine and IV etoposide in pediatric patients wtih relapsed/refractory AML/ALL.
Interventions
Plerixafor dose escalation Dose Level -1 = 3 mg/m2/dose Dose Level 1 = 6 mg/m2/dose Dose Level 2 = 9 mg/m2/dose Dose Level 3 = 12 mg/m2/dose Dose Level 4 = 15 mg/m2/dose Doses administered 4 hours prior to chemotherapy, then at the same approximate time of day on subsequent days, through the end of that cycle of chemotherapy.
Eligibility Criteria
You may qualify if:
- \>= 3 years of age and \<30 years old at study entry
- diagnosis of relapsed/refractory AML, ALL, secondary AML/MDS, or acute leukemia of ambiguous lineage and meet the following criteria:
- AML/MDS or leukemia with ambiguous lineage must have \>5% blast in bone marrow
- ALL must have an M3 marrow
- ALL and AML must not have CNS disease
- patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy or radiotherapy prior to entering study
- Karnofsky score \>50% for patients \>16 years of age and Lansky \>50% for patients \<= 16 years of age
- adequate renal and hepatic function as defined in protocol
- adequate cardiac function as defined in protocol
You may not qualify if:
- ALL and AML patients with CNS disease
- Absolute blast count greater than 50,000/mcl
- Systemic fungal, bacterial, viral or other infection without improvement despite appropriate antibiotics or other treatment
- Significant concurrent disease, illness, psychiatric disorder or social issue that would compromise patient safety or compliance
- Patients who have second cancer, not including secondary AML
- Patients who are pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Phoenix Children's Hospital
Phoenix, Arizona, 85016, United States
The Children's Hospital of Denver
Denver, Colorado, 80045, United States
Children's Healthcare of Atlanta/Emory University
Atlanta, Georgia, 30322, United States
Johns Hopkins Medical Center
Baltimore, Maryland, 21231, United States
The Children's Mercy Hospital and Clinics
Kansas City, Missouri, 64108, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Penn State Hershey Children's Hospital
Hershey, Pennsylvania, 17033, United States
Alberta Children's Hospital
Calgary, Alberta, T3B 6A8, Canada
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Todd Cooper, DO
Emory University/Children's Healthcare of Atlanta
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
March 11, 2011
First Posted
March 22, 2011
Study Start
March 1, 2011
Primary Completion
June 28, 2013
Study Completion
June 28, 2016
Last Updated
September 7, 2018
Record last verified: 2018-09