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Pilot Study of Using Granulocyte Colony Stimulating Factor-Primed Bone Marrow in Histocompatible Sibling Allogeneic Bone Marrow Transplantation for Patients With Hematologic Malignancies and Non-Malignancies


N/A
N/A
55 Years
Not Enrolling
Both
Hematologic Diseases, Hematologic Malignancies

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Trial Information

Pilot Study of Using Granulocyte Colony Stimulating Factor-Primed Bone Marrow in Histocompatible Sibling Allogeneic Bone Marrow Transplantation for Patients With Hematologic Malignancies and Non-Malignancies


This study is a single-arm, non-randomized trial. Patients meeting the criteria for this
study will be entered sequentially until completion or closure of the study. Early stopping
rules will be employed to ascertain whether an unacceptable rate of toxicity
(non-engraftment, and/or acute GvHD) occurs.

Patients will be prepared for transplant through the administration of one of the following
conditioning regimen based on his/her primary disease:

5.1 Total body irradiation 1200 rads in 6 fractionated doses and high dose chemotherapy,
including etoposide and cyclophosphamide.

5.2 High dose chemotherapy with busulfan and cyclophosphamide. 5.2.1 Patients who are not
candidates for TBI will receive chemotherapy-based conditioning regimen.

5.3 Post transplant immunosuppression prophylaxis against acute GVHD will include
cyclosporine and methotrexate.

5.4 Donor will receive 3 daily G-CSF injections (starting on day -3) prior to marrow
harvest. The injections may be initiated by the donor's primary physician prior to donor's
arrival here, or by BMT service at Children's Healthcare of Atlanta.

5.5 Patients will receive daily G-CSF injections (5 mcg/kg) starting from day+5 post
transplant.


Inclusion Criteria:



- Patients with hematologic malignancies and non-malignancies who are candidates for
matched sibling donor allogeneic bone marrow transplantation are eligible for this
study.

- Patients who are under 55 years of age.

- Patients who have a life expectancy of at least 12 weeks and a performance status of
at least 2 Zubrod or 70% Karnofsky status prior to transplantation.

- Patients who are acceptable candidates for marrow transplantation based on their
pre-BMT evaluation.

- Patients who have available histocompatible siblings who have been medically approved
as marrow donors.

- Patients who sign informed consent for the protocol approved by the Institutional
Review Board of Emory University/Children's Healthcare of Atlanta.

- Donors must be 5 years of age or older, and have completed routine donor evaluations
and signed (by parent or legal guardian) informed consent for the protocol approved
by the Institutional Review Board of Emory University/Children's Healthcare of
Atlanta.

Exclusion Criteria:

- 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 a 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 (e.g. certain fungal species, HIV, etc.).

- Patients with hemoglobinopathy (e.g. sickle cell disease and thalassemia) will
not be eligible for this protocol. However, filgrastim mobilization, large
volume apheresis, processing, and cryopreservation appears to be safe in donors
with sickle cell trait.

- Patients have had greater than two leukemic episodes, active central nervous
system (CNS) and/or leukemic disease and blast crisis in chronic myelogenous
leukemia (CML) patients.

- 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 previous stem cell transplant will be excluded.

- Donors will be excluded if they are sensitive to E. coli-derived protein.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Evaluate the curative potential of white cell growth hormone (G-CSF)-stimulated bone marrow cells in allogeneic bone marrow transplants.

Outcome Time Frame:

1 year after study completion

Safety Issue:

No

Principal Investigator

Kuang-Yueh Chiang, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Emory University/CHOA

Authority:

United States: Institutional Review Board

Study ID:

561-2003

NCT ID:

NCT00231309

Start Date:

July 2003

Completion Date:

November 2011

Related Keywords:

  • Hematologic Diseases
  • Hematologic Malignancies
  • G-CSF
  • Bone Marrow
  • Hematologic malignancies
  • Non-malignancies
  • Matched sibling donor
  • Allogeneic BMT
  • Neoplasms
  • Hematologic Diseases
  • Hematologic Neoplasms

Name

Location

Children's Healthcare of Atlanta/Emory UniversityAtlanta, Georgia  30322