POETIC Plerixafor as a Chemosensitizing Agent for Relapsed Acute Leukemia and MDS in Pediatric Patients

Completed · Phase 1

Conditions studied: Relapsed/Refractory AML, Relapsed/Refractory ALL, Secondary AML/MDS, Acute Leukemia of Ambiguous Lineage, AML, ALL

In brief

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.

Key facts

Study ID

NCT01319864

Run by

Seattle Children's Hospital

People needed

20

Starts

2011-03-01

Expected to finish

2016-06-28

Last updated by the study team

2018-09-07

Who can join

Age: 3 and older, up to 29. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Phoenix Children's Hospital — Phoenix, Arizona, United States
• The Children's Hospital of Denver — Denver, Colorado, United States
• Children's Healthcare of Atlanta/Emory University — Atlanta, Georgia, United States
• Johns Hopkins Medical Center — Baltimore, Maryland, United States
• The Children's Mercy Hospital and Clinics — Kansas City, Missouri, United States
• Memorial Sloan-Kettering Cancer Center — New York, New York, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Penn State Hershey Children's Hospital — Hershey, Pennsylvania, United States
• Alberta Children's Hospital — Calgary, Alberta, Canada

Full record on ClinicalTrials.gov

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