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

• Status: Completed
• Trial end date: 2016-06-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seattle Children's Hospital
• Collaborators: Children's Healthcare of Atlanta; Pediatric Oncology Experimental Therapeutics Investigation Consortium
• Treatments: JM 3100; Plerixafor

Criteria

Inclusion Criteria:

• >= 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

Exclusion Criteria:

• 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