Trial record 1 of 1 for:    NCT01026987
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Granulocyte Colony-stimulating Factor (G-CSF) Plus or Minus AMD3100 for Engraftment Post Allogeneic Transplant

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01026987
First received: December 1, 2009
Last updated: July 8, 2014
Last verified: July 2014
  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 Phase
Stem Cell Transplant Patients
Drug: G-CSF
Drug: AMD3100
Procedure: Leukapheresis
Procedure: Stem Cell Infusion
Phase 0

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:


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

Primary Outcome Measures:
  • Time to neutrophil engraftment [ Time Frame: 100 days post CD34+ selected, T-Cell depleted transplant ] [ Designated as safety issue: No ]

    For recipients with ANC < 500 or growth factor support dependent at study entry, Time to neutrophil improvement is measured from the date of CD34+ selected, T-Cell depleted infusion to the first of 3 consecutive measurements of neutrophil count > 500/μl without growth factor support for >7 days prior.

    RBC transfusion engraftment - independence from RBCs without growth factors.


  • Time to platelet engraftment [ Time Frame: 100 days post CD34+ selected, T-Cell depleted transplant ] [ Designated as safety issue: No ]
    For recipients with platelets < 20,000 or platelet transfusion dependent at study entry, Time to platelet improvement is measured from the date of CD34+ selected, T-Cell depleted infusion to the of 3 consecutive measurements of platelet count ≥ 20,000/ulwithout platelet transfusion support for 7 days.

  • Time to red blood cell (RBC) improvement [ Time Frame: 100 days post CD34+ selected, T-Cell depleted transplant ] [ Designated as safety issue: No ]
    For recipients who are RBC transfusion dependent at study entry, Time to RBC improvement is measured from the date of CD34+ selected, T-Cell depleted infusion to the first date of hemoglobin >9.0g/dL without > 1 RBC transfusion during the previous 56 days.


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: Day 0 (transplant day) ] [ Designated as safety issue: No ]
  • Toxicities associated with the CD34+ collection (donors) [ Time Frame: 30 days post mobilization ] [ Designated as safety issue: Yes ]
    NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.

  • 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: Day of mobilization (Day 0) ] [ Designated as safety issue: Yes ]
  • Overall survival (recipients) [ Time Frame: 1 year from date of transplant ] [ Designated as safety issue: No ]
    Overall survival is the time from the date of CD34+ selected, T-Cell depleted infusion to death.

  • Incidence and severity of acute Graft vs Host Disease (GVHD) [ Time Frame: 100 days post-transplant ] [ Designated as safety issue: Yes ]
    Incidence and severity of acute GVHD will be assessed based on the Seattle criteria

  • Toxicites associated with CD34+ cell infusion (recipients) [ Time Frame: 30 days post-transplant ] [ Designated as safety issue: Yes ]
    NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.

  • Disease-free survival [ Time Frame: 1 year from date of transplant ] [ Designated as safety issue: No ]
    Disease-Free survival is the time from the date of CD34+ selected, T-Cell depleted infusion to disease relapse or death.

  • Incidence and severity of acute Graft vs Host Disease (GVHD) [ Time Frame: 2 years post-transplant ] [ Designated as safety issue: Yes ]
    Incidence and severity of chronic GVHD will be assessed based on the Seattle criteria

  • Rate of transplant-related mortality (TRM) [ Time Frame: 100 days post-transplant ] [ Designated as safety issue: Yes ]

Enrollment: 29
Study Start Date: April 2010
Estimated Study Completion Date: December 2015
Primary Completion Date: April 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01026987

Locations
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: John DiPersio, M.D., Ph.D. Washington University School of Medicine
  More Information

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: July 8, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 22, 2014