Intravenous (IV) AMD3100 for Mobilization and Matched Related Transplant for Advanced Hematological Malignancies

Completed · Phase 2

Conditions studied: Hematologic Neoplasms

In brief

To reduce the number of donors treated with IV AMD3100 who require a second collection to obtain the minimum cells necessary for allogeneic stem cell transplant.

Key facts

Study ID

NCT00914849

Run by

Washington University School of Medicine

People needed

68

Starts

2009-08-01

Expected to finish

2012-02-01

Last updated by the study team

2017-05-17

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 70 years of age inclusive.
• If female and of child-bearing age: must be non-pregnant, not breast feeding and agree to use adequate contraception.
• Donor is a 6/6 HLA-matched sibling willing to donate PBSC for transplant.
• Donor must be willing to provide written informed consent.
• Adequate cardiac function with no history of congestive heart failure and no history of atrial fibrillation or ventricular tachyarrhythmia.
• Adequate renal function as defined by a calculated serum creatinine clearance of ≥75% of normal (Cockcroft-Gault equation).
• Adequate hepatic function as defined by a total bilirubin <2x normal or absence of hepatic fibrosis/cirrhosis.
• 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 Food and Drug Administration (FDA) licensed test.
• Donor must have an Eastern Cooperative Oncology Group (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.
• Recipient Eligibility
• Recipient must have available the successful collection of an AMD3100 mobilized product. When an adequate collection cannot be obtained using G-CSF, some recipients may need to receive a combined product of mobilized cells with AMD3100 and g granulocyte-colony stimulating factor (G-CSF). Recipients who receive less than 2.0 X 106 CD34+ cells/kg/actual recipient weight after two days of IV AMD3100 will not be considered "eligible" but followed per protocol for safety purposes only.
• Patient is 18 to 65 years of age inclusive.
• Patient is willing and has a 6/6 HLA-matched sibling willing to donate PBSC for transplant.
• Patient must provide signed informed consent.
• If female and of child-bearing age: must be non-pregnant, not breast feeding, and uses adequate contraception.
• Patient 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…

• See Inclusion criteria above

Where it is running

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

Full record on ClinicalTrials.gov

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