Plerixafor and Sargramostim (GM-CSF) for Mobilization of Allogeneic Sibling Donors

Completed · Phase 2

Conditions studied: Leukemia, Myeloid, Acute, Myelodysplastic Syndromes, Lymphoma, Non-Hodgkin, Hodgkin Disease, Leukemia, Lymphocytic, Chronic, B-Cell, Multiple Myeloma

In brief

This study will gather information about the combination the drugs plerixafor with sargramostim in donors of blood-forming cells (stem cells). These stem cells will be collected from the donor and transplanted into their sibling. The investigators believe that the two drugs together will provide enough stem cells for transplantation and may also reduce the risk of graft versus host disease.

Key facts

Study ID

NCT01158118

Run by

Washington University School of Medicine

People needed

48

Starts

2011-04-01

Expected to finish

2016-12-31

Last updated by the study team

2017-06-05

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Donor Eligibility
• Donor is 18 to 65 years of age inclusive.
• If female and of child-bearing age, donor must be non-pregnant, not breastfeeding, and agree to use adequate contraception.
• Donor is a 6/6 HLA-matched sibling willing to donate PBSC for transplant.
• Donor has adequate cardiac function with no history of congestive heart failure and no history of atrial fibrillation or ventricular tachyarrhythmia.
• Donor has adequate renal function as defined by a calculated serum creatinine clearance of ≥56 ml/min for females and ≥64 ml/min for males.
• Donor has adequate hepatic function as defined by a total bilirubin <2x normal or absence of hepatic fibrosis/cirrhosis.
• Donor has adequate neurologic function as defined by NO evidence of a severe central or peripheral neurologic abnormality. No history of cerebrovascular accident or seizure disorder requiring anticonvulsant medication.
• Donor must be HIV-1\&2 antibody and HTLV-I\&II antibody sero-negative, by FDA licensed test.
• Donor must have an ECOG performance status of 0 or 1.
• Donor must demonstrate ability to be compliant with study regimen.
• Donor must not have an active infection at the time of study entry.
• Donor does not have active alcohol or substance abuse within 6 months of study entry.
• Donor is not currently enrolled on another investigational agent study.
• Donor does not have any medical condition, which, in the opinion of the clinical investigator, would interfere with his/her evaluation.
• Ability of the donor to understand and the willingness to sign a written informed consent document.
• Recipient Eligibility
• Recipient must have available the successful collection of a GM-CSF + plerixafor mobilized product. When an adequate collection cannot be obtained, G-CSF will be used and some recipients may need to receive a combined product of mobilized cells with plerixafor + GM-CSF and G-CSF mobilized cells. Recipients who receive less than 2.0 X 106 CD34+ cells/kg/actual recipient weight after six days of GM-CSF and two days of IV plerixafor will not be considered "eligible" but followed per protocol for safety purposes only.
• Recipient is 18 to 65 years of age inclusive.
• Recipient is willing and has a 6/6 HLA-matched sibling willing to donate PBSC for transplant.
• Recipient must provide signed informed consent.
• If female and of child-bearing age, recipient must be non-pregnant, not breastfeeding, and using adequate contraception.
• Recipient must have one of the following diagnoses:
• Acute myelogenous leukemia (AML) in 1st or subsequent remission or in relapse,
• Acute lymphoblastic leukemia (ALL) in 1st or subsequent remission or in relapse,

You may not qualify if…

• Donor Exclusion Criteria in addition to that stated above
• Donor may not be receiving any other investigational agents.
• Donor may not have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to plerixafor or GM-CSF, or known hypersensitivity to yeast-derived products or any component of the product.

Where it is running

• Washington University School of Medicine — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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