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

The Washington University

Status and phase: Completed; Phase 1

Conditions: Stem Cell Transplant Patients

Treatments: Procedure: Leukapheresis; Procedure: Stem Cell Infusion; Drug: G-CSF; Drug: AMD3100

Study type: Interventional

Funder types: Other

Identifiers

NCT01026987

09-1824 / 201011859

Details and patient eligibility

About

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.

Full description

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.

The unrelated donors will receive G-CSF prior to pheresis (collection of the stem cells) to boost the number of CD34+ cells. The related donors will receive G-CSF and AMD3100 prior to pheresis to boost the number of CD34+ cells. Once the CD34+ cells are collected they will be T-cell depleted using a cell separation device called the CliniMACS systems. The CliniMACS system will select the CD34+ cell and remove the T-cells. By removing the T-cells we can minimize the risk of Graft Versus Host Disease (GVHD). The enriched CD34+ cells will be given to them to hopefully give them a "boost" of cells that can permanently produce new blood cells to improve their risk of infection and bleeding.

Enrollment: 29 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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29 participants in 2 patient groups

Related Donors: G-CSF & AMD3100

Experimental group

Description:

G-CSF 10 ug/kg SC daily for 5 days. AMD3100 320 mcg/kg IV over 30 min on Day 5. Leukapheresis on Day 5.

Treatment:

Drug: AMD3100

Drug: G-CSF

Procedure: Leukapheresis

Recipient

Other group

Description:

Stem Cell Infusion on Day 0

Treatment:

Procedure: Stem Cell Infusion