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

NCT01026987 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: 09-1824 / 201011859
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stem Cell Transplant Patients

Outcome Measures

Primary Outcomes (3)

• 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.

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

• 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.

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

• 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.

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

Secondary Outcomes (9)

• 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.

  Day 0 (transplant day)

• Toxicities associated with the CD34+ collection (donors)

  30 days post mobilization

• 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.

  Day of mobilization (Day 0)

• Overall survival (recipients)

  1 year from date of transplant

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

  100 days post-transplant

Study Arms (2)

Related Donors: G-CSF & AMD3100

EXPERIMENTAL

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; Drug: AMD3100; Procedure: Leukapheresis

Recipient

OTHER

Stem Cell Infusion on Day 0

Procedure: Stem Cell Infusion

Interventions

G-CSF DRUG

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.

Also known as: Neupogen

Related Donors: G-CSF & AMD3100

AMD3100 DRUG

Also known as: Plerixafor, Mozobil

Related Donors: G-CSF & AMD3100

Leukapheresis PROCEDURE

Related Donors: G-CSF & AMD3100

Stem Cell Infusion PROCEDURE

Recipient

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Interventions

Granulocyte Colony-Stimulating Factor; Filgrastim; plerixafor; Leukapheresis

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Cytapheresis; Biological Therapy; Therapeutics; Blood Component Removal; Leukocyte Reduction Procedures; Cell Separation; Cytological Techniques; Clinical Laboratory Techniques; Investigative Techniques

Study Officials

• John DiPersio, M.D., Ph.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2009
• First Posted: December 7, 2009
• Study Start: April 29, 2010
• Primary Completion: April 1, 2014
• Study Completion: June 8, 2016
• Last Updated: January 25, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)