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

• Status: Completed
• Trial end date: 2016-06-08
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Washington University School of Medicine
• Treatments: JM 3100; Lenograstim; Plerixafor

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.