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

This study is currently recruiting participants.
Verified April 2013 by Washington University School of Medicine
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01026987
First received: December 1, 2009
Last updated: April 12, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition Intervention
Stem Cell Transplant Patients
 Drug: G-CSF
Drug: AMD3100
Procedure: Leukapheresis
Procedure: Stem Cell Infusion

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • To investigate whether "booster" infusions of T-cell depleted, CD34+ enriched donor cells mobilized using G-CSF +/- plerixafor can improve blood counts and transfusions in patients with limited donor engraftment following allogeneic transplant. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

    Time to neutrophil engraftment (neutrophils >500/ul for 3 consecutive days)

    Time to platelet engraftment (platelets >20,000 for 7 days without platelet transfusion)

    RBC transfusion engraftment - independence from RBCs without growth factors.



Secondary Outcome Measures:
  • 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. [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
  • To assess the donor and recipient toxicities associated with the "booster" CD34+ cell collection and infusion. [ Time Frame: 1 year (recipients) & 48 hours after leukapheresis (donors) ] [ Designated as safety issue: Yes ]
  • To 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. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • To assess the overall survival and disease-free survival at 6 months and 12 months after a single CD34+ selected donor stem cell infusion. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • To assess the incidence and severity of acute and chronic Graft vs Host Disease (GVHD) following "booster" infusion. [ Time Frame: 100 days post transplant (acute) and 2 years post transplant (chronic) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: April 2010
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Related Donors: G-CSF & AMD3100
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.
 Drug: G-CSF
Unrelated donors will receive only G-CSF (10 ug/Kg S/C qDay x5-6 days) prior to pheresis (collection of the stem cells). Unrelated donors will only be followed per NMDP guidelines.
Other Name: Neupogen
Drug: AMD3100
Other Names:
  • Plerixafor
  • Mozobil
Procedure: Leukapheresis
Recipient
Stem Cell Infusion on Day 0
 Procedure: Stem Cell Infusion

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01026987

Contacts
Contact: Sarah Merida 314-747-2449 smerida@dom.wustl.edu

Locations
United States, Missouri
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Contact: John DiPersio, M.D.,Ph.D.     314-454-8304     jdipersi@dom.wustl.edu    
Sub-Investigator: Giridharan Ramsingh, M.D.            
Sub-Investigator: Camille Abboud, M.D.            
Sub-Investigator: Ravi Vij, M.D.            
Sub-Investigator: Iskra Pusic, M.D.            
Sub-Investigator: Peter Westervelt, M.D., Ph.D.            
Sub-Investigator: Timothy Graubert, M.D.            
Sub-Investigator: Keith Stockerl-Goldstein, M.D.            
Sub-Investigator: Michael Tomasson, M.D.            
Sub-Investigator: Matthew Walter, M.D.            
Sub-Investigator: Amanda Cashen, M.D.            
Sub-Investigator: Geoffrey Uy, M.D.            
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: John DiPersio, M.D., Ph.D. Washington University School of Medicine
  More Information

Additional Information:
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01026987     History of Changes
Other Study ID Numbers: 09-1824 / 201011859
Study First Received: December 1, 2009
Last Updated: April 12, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lenograstim
JM 3100
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
 Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013