AML Clinical Trial
Official title:
A Phase I Study Using Plerixafor as a Chemosensitizing Agent for Relapsed Acute Leukemia and MDS in Pediatric Patients
Verified date | September 2018 |
Source | Seattle Children's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | June 28, 2016 |
Est. primary completion date | June 28, 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Years to 29 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Canada | Alberta Children's Hospital | Calgary | Alberta |
United States | Children's Healthcare of Atlanta/Emory University | Atlanta | Georgia |
United States | Johns Hopkins Medical Center | Baltimore | Maryland |
United States | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio |
United States | The Children's Hospital of Denver | Denver | Colorado |
United States | Penn State Hershey Children's Hospital | Hershey | Pennsylvania |
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 | Phoenix Children's Hospital | Phoenix | Arizona |
Lead Sponsor | Collaborator |
---|---|
Seattle Children's Hospital | Children's Healthcare of Atlanta, Pediatric Oncology Experimental Therapeutics Investigation Consortium |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Response Rate | To estimate the response rate, within the context of a Phase I study, of Plerixafor given in sequential combination with cytarabine/etoposide (AE) in patients with relapsed or refractory ALL and AML/MDS. | 6 months post completion of treatment for final enrollment | |
Secondary | Measure Peak Plasma Concentration (Cmax) of Plerixafor using serial peripheral blood sampling | Plasma pharmacokinetic parameters are estimated by noncompartmental analysis using PhoenixWinNonlin 7.0 (Certara) and are estimated from the observed concentration-time data. | 12 months following last sample collection | |
Secondary | Leukemic blast mobilization | To measure peripheral blood mobilization of leukemic blasts by flow cytometry by comparing blood samples obtained before and after dose 1 of plerixafor, and to correlate degree of mobilization (expressed as % increase in circulating blasts) with response. | 12 months after final sample collection | |
Secondary | CXCR4 expression on leukemic blasts | To measure the quantitative expression of CXCR4 on leukemic blasts at baseline and end of first course of treatment using flow cytometry and qRT-PCR, and correlate expression level with response. | 12 months after last patient completes therapy | |
Secondary | Measure Area Under the Concentration-Time Curve (AUC) of Plerixafor using serial peripheral blood sampling | Plasma pharmacokinetic parameters are estimated by noncompartmental analysis using PhoenixWinNonlin 7.0 (Certara) and are estimated from the observed concentration-time data. | 12 months following last sample collection | |
Secondary | Measure terminal half life (t1/2) of Plerixafor using serial peripheral blood sampling | Plasma pharmacokinetic parameters are estimated by noncompartmental analysis using PhoenixWinNonlin 7.0 (Certara) and are estimated from the observed concentration-time data. | 12 months following last sample collection | |
Secondary | Measure systemic clearance of Plerixafor using serial peripheral blood sampling | Plasma pharmacokinetic parameters are estimated by noncompartmental analysis using PhoenixWinNonlin 7.0 (Certara) and are estimated from the observed concentration-time data. | 12 months following last sample collection |
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