DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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 engraftment

Time 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

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017