G-CSF PMRD: Granulocyte Colony Stimulating Factor (G-CSF) Stimulated Bone Marrow and In Vivo T-Cell Depletion in Patients With Hematologic Malignancies or Bone Marrow Failure Syndrome

NCT00228813 | Terminated Results DMC

• 2 other identifiers: IRB000218190159-2004
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The purposes of this study are:

• To examine the engraftment rate in patients receiving in vivo T-cell-depleted G-CSF stimulated bone marrow from partially mismatched related donors.
• To evaluate the incidence and severity of acute and chronic graft-versus-host disease in patients receiving in vivo T-cell-depleted G-CSF stimulated bone marrow from partially mismatched related donors.

Conditions

Hematologic Malignancies

Outcome Measures

Primary Outcomes (3)

• Engraftment Rate

  The number of participants who received in vivo T-cell-depleted G-CSF stimulated bone marrow from partially mismatched related donor who reached engraftment by Day 45.

  Day 45

• Incidence of Acute Graft-versus-host Disease

  The number of participants diagnosed with new acute graft-versus-host disease (GVHD).

  Day 100

• Incidence of Chronic Graft-versus-host Disease

  The number of participants diagnosed with chronic graft-versus-host disease (GVHD).

  Duration of Study (Up to two years)

Study Arms (1)

Granulocyte Colony Stimulating Factor (G-CSF) stimulation

OTHER

Participants will receive bone marrow from donors who undergo Granulocyte Colony Stimulating Factor (G-CSF) stimulation prior to bone marrow collection.

Drug: Granulocyte Colony Stimulating Factor

Interventions

Granulocyte Colony Stimulating Factor DRUG

FILGRASTIM: G-CSF (NEUPOGEN®) is administered as a short IV infusion over 30 minutes or subcutaneously. It is given beginning on day -3 for 3 days to the donor prior to the bone marrow harvest. Drug Information: FILGRASTIM: G-CSF (Neupogen®) Formulation: G-CSF is available as a preservative-free solution for injection in 1.0 ml and 1.6 ml vials containing 300 mcg/ml. Administration: G-CSF 5 mcg/kg/d will be given subcutaneously or as a short I.V. infusion over 30 minutes. Recombinant GM-CSF at the dose of 250 mcg/m2 will be given intravenously from day +7 to help white counts recovery. The drug will be diluted in NS at a concentration of at least 10 mcg/ml. Drug Information: Sargramostim (Leukine) Formulation: 250 mcg, 500 mcg lyophlized powder for injection

Granulocyte Colony Stimulating Factor (G-CSF) stimulation

Eligibility Criteria

• Age: Up to 22 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients with hematologic malignancies or bone marrow failure syndrome who are candidates for allogeneic bone marrow transplantation are eligible for this study. Hematologic malignancies indicated for transplantation:
• Acute lymphoblastic leukemia (ALL) in first remission (with high risk feature), 2nd or greater remission.
• Acute myeloid leukemia (AML) in first remission (with high risk feature), 2nd or greater remission.
• Chronic myeloid leukemia (CML) in 2nd chronic phase or accelerated phase.
• Juvenile myelomonocytic leukemia (JMML).
• Myelodysplastic syndrome.
• Biphenotypic leukemia in first (with high risk feature), 2nd or greater remission.
• Induction failure leukemia.
• Refractory relapsed leukemia.
• Bone marrow failure syndrome.
• Severe aplastic anemia failed immunotherapy.
• Patients who do not have a 6 out of 6 matched related or unrelated donor or 4/6 and 5/6 matched cord blood will be eligible for this study.
• Partially mismatched related donor availability as defined by molecular typing with 3 to 5 HLA matches.
• Patients who are under 22 years of age.

You may not qualify if:

• Patients will not be excluded based on sex, racial, or ethnic background.
• Patients will be excluded if they demonstrate significant functional deficits in major organs, which would obviously interfere with successful outcome following bone marrow transplant utilizing the following guidelines.
• Evidence of active, deep-seated, life-threatening infections for which there is no known effective therapy (certain fungal species, HIV, etc.).
• Patients who have been treated for infections must have appropriate responses as documented by 2 (two) consecutive negative cultures and/or stable radiographic examinations.
• Patients who have active central nervous system (CNS) leukemic disease.
• Patients will be excluded if they are women of childbearing potential who are currently pregnant (beta-HCG+) or who are not practicing adequate contraception.
• Patients who have had a previous hematopoietic stem cell transplant will be excluded.
• Donors will be excluded if they are sensitive to E. coli-derived protein.

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Children's Healthcare of Atlanta/Emory University

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Granulocyte Colony-Stimulating Factor

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

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

Limitations and Caveats

There was a small number of participants and a short follow up time period for this trial.

Results Point of Contact

• Title: Kuang-Yueh Chiang, MD
• Organization: Emory University

kchian2@emory.edu

404-785-0858

Study Officials

• Kuang-Yueh Chiang, M.D.

  Children's Healthcare of Atlanta/Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2005
• First Posted: September 29, 2005
• Study Start: April 1, 2004
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: September 11, 2017
• Results First Posted: July 6, 2016

Record last verified: 2017-08

Locations

US (1)