Granulocyte Colony-stimulating Factor (G-CSF) Plus or Minus AMD3100 for Engraftment Post Allogeneic Transplant

Completed · Phase 1

Conditions studied: Stem Cell Transplant Patients

In brief

Patients who have not had adequate blood count recovery post related or unrelated stem cell transplant will be given a "boost" of T-cell depleted, enriched stem cells to hopefully improve their blood counts.

Key facts

Study ID

NCT01026987

Run by

Washington University School of Medicine

People needed

29

Starts

2010-04-29

Expected to finish

2016-06-08

Last updated by the study team

2017-01-25

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Recipient
• Must be age ≥ 18
• Must have ≥90 % donor cells in the unfractionated peripheral blood based on either XY FISH or standard STR.
• More than 60 days post allogeneic stem cell transplantation.
• Must meet one of the following criteria:
• platelets < 20,000 or
• ANC<500 or
• transfusion dependent for at least one cell line and /or
• on growth factor support (G-CSF) without adequate response for 30 days and
• no reversible etiology found after an allogeneic stem cell transplantation
• Patient has an ECOG performance status of 0-2.
• The original stem cell donor must be available, willing, and medically able to undergo Mobilization and a maximum of 2 apheresis procedures
• Each patient (recipient) or legal guardian and donor must be willing to participate as a research subject and must sign an informed consent form.
• Unrelated Donors
• NMDP guidelines for eligibility will be followed using G-CSF alone mobilization.
• Related donors
• Must be ≥18 yrs old and ≤ 75 years old.
• Donor must be sero-negative for HIV-1\&2 antibody and HTLV-I\&II antibody, by FDA licensed test.
• Donor must have adequate renal function as defined by serum creatinine ≤ 1.5X institution ULN and AST and ALT ≤ 3X ULN and total bilirubin less than 2 mg/dl.
• Donor must be agreeable to mobilization and the second donation of PBMC.
• Women of child bearing potential should be willing to avoid becoming pregnant while receiving treatment with plerixafor.
• Donor must have adequate peripheral venous catheter access for leukapheresis or must agree to placement of a central catheter.

You may not qualify if…

• Recipient
• Patients with confirmed relapse of their original disease
• Participation in other clinical trials that involve investigational drugs or devices except with permission from the Principal Investigator and Sponsor.
• Patients with documented active viral, bacterial or fungal infections.
• Documented allergy to murine proteins or iron dextran.
• Pregnancy
• Patients with immune mediated graft dysfunction.
• Donor
• Evidence of active infection at the time of study entry.
• Medical or physical reason which makes the donor unlikely to tolerate or cooperate with growth factor therapy and leukapheresis
• Factors which place the donor at increased risk for complications from leukapheresis or G-CSF therapy(e.g., autoimmune disease, multiple sclerosis, sickle cell trait, coronary artery disease).
• Pregnancy (positive serum or urine beta-HCG) or breastfeeding. Women of childbearing age must avoid becoming pregnant while on the study.

Where it is running

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

Full record on ClinicalTrials.gov

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