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AzTrials

Stem Cell Transplant PatientsPhase 1NCT01026987

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

A Phase 1 study testing G-CSF, AMD3100 and Leukapheresis in people with Stem Cell Transplant Patients, run by Washington University School of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Stem Cell Transplant Patients
What is being tested?
G-CSF, AMD3100 and Leukapheresis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
1 siteUnited States
Study dates
29 Apr 2010to 8 Jun 2016
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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
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  • 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 locations and contacts

1 site in 1 country.

United States1 site

  • Washington University School of Medicine

    St Louis, Missouri, 63110

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
G-CSF, AMD3100, Leukapheresis, Stem Cell Infusion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • G-CSFDrug

    Also called Neupogen

    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.

  • AMD3100Drug

    Also called Plerixafor, Mozobil

  • LeukapheresisProcedure or surgery

  • Stem Cell InfusionProcedure or surgery

Study groups in NCT01026987
Study groupRoleWhat they receive
Related Donors: G-CSF & AMD3100ExperimentalG-CSF 10 ug/kg SC daily for 5 days. AMD3100 320 mcg/kg IV over 30 min on Day 5. Leukapheresis on Day 5.
Receives: Drug: G-CSF; Drug: AMD3100; Procedure: Leukapheresis
RecipientOtherStem Cell Infusion on Day 0
Receives: Procedure: Stem Cell Infusion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to neutrophil engraftment

    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.

    Measured: 100 days post CD34+ selected, T-Cell depleted transplant

  2. Time to platelet engraftment

    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/ul without platelet transfusion support for 7 days.

    Measured: 100 days post CD34+ selected, T-Cell depleted transplant

  3. Time to red blood cell (RBC) improvement

    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.

    Measured: 100 days post CD34+ selected, T-Cell depleted transplant

Secondary outcomes (9)

  1. 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.

    Measured: Day 0 (transplant day)

  2. Toxicities associated with the CD34+ collection (donors)

    NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.

    Measured: 30 days post mobilization

  3. 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.

    Measured: Day of mobilization (Day 0)

  4. Overall survival (recipients)

    Overall survival is the time from the date of CD34+ selected, T-Cell depleted infusion to death.

    Measured: 1 year from date of transplant

  5. Incidence and severity of acute Graft vs Host Disease (GVHD)

    Incidence and severity of acute GVHD will be assessed based on the Seattle criteria

    Measured: 100 days post-transplant

  6. Toxicities associated with CD34+ cell infusion (recipients)

    NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.

    Measured: 30 days post-transplant

  7. Disease-free survival

    Disease-Free survival is the time from the date of CD34+ selected, T-Cell depleted infusion to disease relapse or death.

    Measured: 1 year from date of transplant

  8. Incidence and severity of acute Graft vs Host Disease (GVHD)

    Incidence and severity of chronic GVHD will be assessed based on the Seattle criteria

    Measured: 2 years post-transplant

  9. Rate of transplant-related mortality (TRM)

    Measured: 100 days post-transplant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Dec 2009 (estimated)
  2. Study start29 Apr 2010
  3. Primary completionApr 2014
  4. Study completion8 Jun 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01026987
Sponsor's protocol ID
09-1824 / 201011859
Status last verified
Jan 2017
First submitted
1 Dec 2009
Last updated
25 Jan 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing G-CSF, AMD3100 and Leukapheresis in people with Stem Cell Transplant Patients, run by Washington University School of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to neutrophil engraftment (time frame: 100 days post CD34+ selected, T-Cell depleted transplant). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01026987.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2017; AzTrials last refreshed its copy on 31 Oct 2026.

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