Study Evaluating AMD3100 for Transplantation of Sibling Donor Stem Cells in Patients With Hematological Malignancies

Completed · Phase 1/Phase 2

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

In brief

The purpose of this study is to determine if peripheral blood cells collected following AMD3100 mobilization can be used safely for hematopoietic cell transplantation into HLA-matched recipients.

Key facts

Study ID: NCT00241358
Run by: Washington University School of Medicine
People needed: 92
Starts: 2004-05-01
Expected to finish: 2010-02-01
Last updated by the study team: 2017-06-06

Who can join

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

You may qualify if…

Donor criteria:
Donor is 18 to 70 years of age inclusive
If female and of child-bearing age, must be:
non-pregnant,
not breast feeding and
using adequate contraception
Donor is a 6/6 HLA-matched sibling willing to donate peripheral blood stem cell 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 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
Must be HIV-1 \& 2 antibody, HIV-1 antigen, and HTLV-I \& II antibody sero-negative, by FDA licensed test.
Must have an ECOG performance status of 0 or 1
Must demonstrate ability to be compliant with study regimen.
Must not have an active infection at the time of study entry
Not have active alcohol or substance abuse within 6 months of study entry
Not currently enrolled in another investigational agent study
Not have any medical condition, which, in the opinion of the clinical investigator, would interfere with his/her evaluation
Recipient criteria:
18 to 65 years of age inclusive
Willing and has a 6/6 HLA-matched sibling willing to donate PBSC for transplant
Provide signed informed consent

Where it is running

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

Full record on ClinicalTrials.gov

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