Granulocyte Colony-stimulating Factor (G-CSF) Plus or Minus AMD3100 for Engraftment Post Allogeneic Transplant
Information source: Washington University School of Medicine
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Stem Cell Transplant Patients
Intervention: G-CSF (Drug); AMD3100 (Drug); Leukapheresis (Procedure); Stem Cell Infusion (Procedure)
Phase: Phase 0
Status: Active, not recruiting
Sponsored by: Washington University School of Medicine Official(s) and/or principal investigator(s): John DiPersio, M.D., Ph.D., Principal Investigator, Affiliation: Washington University School of Medicine
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.
Clinical Details
Official title: A Pilot Study of G-CSF +/- Plerixafor (AMD3100) Mobilized Donor CD34+ Enriched Peripheral Blood Mononuclear Cells for the Treatment of Allogeneic Stem Cell Transplant Recipients With Limited Donor Engraftment
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Time to neutrophil engraftmentTime to platelet engraftment Time to red blood cell (RBC) improvement
Secondary outcome: To assess the feasibility of collecting adequate donor CD34+ enriched T-cell depleted peripheral blood stem cells using G-CSF+ plerixafor from related donors and G-CSF alone from unrelated donors.Toxicities associated with the CD34+ collection (donors) Phenotypically and functionally characterize donor CD34+ and donor T-cells mobilized by G-CSF from unrelated donors and mobilized with G-CSF + plerixafor from related donors. Overall survival (recipients) Incidence and severity of acute Graft vs Host Disease (GVHD) Toxicites associated with CD34+ cell infusion (recipients) Disease-free survival Incidence and severity of acute Graft vs Host Disease (GVHD) Rate of transplant-related mortality (TRM)
Detailed 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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.
Locations and Contacts
Washington University School of Medicine, St. Louis, Missouri 63110, United States
Additional Information
Starting date: April 2010
Last updated: July 13, 2015
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