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A Pilot Study of Using Filgrastim-Primed Bone Marrow in Human Leukocyte Antigen (HLA) Matched Related Donor Allogenetic Bone Marrow Transplantation for Patients With Hematologic Malignancies and Non-Malignancies


N/A
N/A
24 Years
Not Enrolling
Both
Chronic Myeloproliferative Disorders, Graft Versus Host Disease, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Diseases, Sarcoma

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Trial Information

A Pilot Study of Using Filgrastim-Primed Bone Marrow in Human Leukocyte Antigen (HLA) Matched Related Donor Allogenetic Bone Marrow Transplantation for Patients With Hematologic Malignancies and Non-Malignancies


OBJECTIVES:

Primary

- Determine whether granulocyte engraftment can be achieved by day 30 in patients with
hematologic disorders undergoing HLA-matched, related-donor, allogeneic bone marrow
transplantation using filgrastim (G-CSF)-primed bone marrow.

- Determine the incidence of grade II or greater acute graft-versus-host disease (GVHD)
in patients treated with this regimen and post-transplantation immunosuppression with
cyclosporine and methotrexate.

Secondary

- Determine whether platelet and red blood cell engraftment can be achieved in patients
treated with this regimen.

- Determine the incidence of limited and extensive chronic GVHD in patients treated with
this regimen.

- Determine the event-free survival of patients treated with this regimen.

- Determine the post-transplant immune reconstitution in patients treated with this
regimen.

OUTLINE: This is a pilot study.

- Mobilization: Donors receive filgrastim (G-CSF) subcutaneously (SC) daily on days -3 to
-1 followed by bone marrow collection.

- Conditioning regimen: Patients receive 1 of the following conditioning regimens
according to their primary disease:

- Total-body irradiation and high-dose chemotherapy comprising etoposide and
cyclophosphamide

- High-dose chemotherapy comprising busulfan and cyclophosphamide

- Bone marrow transplantation: Patients receive G-CSF-primed allogeneic bone marrow on
day 0. Patients then receive G-CSF SC beginning on day 5.

- Graft-versus-host disease prophylaxis: Patients receive cyclosporine beginning on day
-1 and methotrexate on days 1, 3, and 6.

PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of hematologic malignancy or nonmalignancy

- Candidate for matched, related-donor, allogeneic bone marrow transplantation

- Availability of an HLA-matched (6/6) related donor

PATIENT CHARACTERISTICS:

Performance status

- ECOG 0-2 OR

- Karnofsky or Lansky 70-100%

Life expectancy

- At least 12 weeks

Hematopoietic

- Not specified

Hepatic

- Not specified

Renal

- Not specified

Other

- No significant functional deficit of any major organ

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No prior stem cell transplantation

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Eneida Nemecek, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

OHSU Knight Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000445188

NCT ID:

NCT00253552

Start Date:

May 2004

Completion Date:

May 2006

Related Keywords:

  • Chronic Myeloproliferative Disorders
  • Graft Versus Host Disease
  • Leukemia
  • Lymphoma
  • Multiple Myeloma and Plasma Cell Neoplasm
  • Myelodysplastic Syndromes
  • Myelodysplastic/Myeloproliferative Diseases
  • Sarcoma
  • graft versus host disease
  • adult acute myeloid leukemia with 11q23 (MLL) abnormalities
  • adult acute myeloid leukemia with inv(16)(p13;q22)
  • adult acute myeloid leukemia with t(15;17)(q22;q12)
  • adult acute myeloid leukemia with t(16;16)(p13;q22)
  • adult acute myeloid leukemia with t(8;21)(q22;q22)
  • accelerated phase chronic myelogenous leukemia
  • adult acute lymphoblastic leukemia in remission
  • adult acute myeloid leukemia in remission
  • atypical chronic myeloid leukemia
  • blastic phase chronic myelogenous leukemia
  • childhood acute lymphoblastic leukemia in remission
  • childhood acute myeloid leukemia in remission
  • childhood chronic myelogenous leukemia
  • chronic eosinophilic leukemia
  • chronic idiopathic myelofibrosis
  • chronic myelomonocytic leukemia
  • chronic neutrophilic leukemia
  • chronic phase chronic myelogenous leukemia
  • de novo myelodysplastic syndromes
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • juvenile myelomonocytic leukemia
  • myelodysplastic/myeloproliferative disease, unclassifiable
  • nodal marginal zone B-cell lymphoma
  • noncontiguous stage II adult Burkitt lymphoma
  • noncontiguous stage II adult diffuse large cell lymphoma
  • noncontiguous stage II adult diffuse mixed cell lymphoma
  • noncontiguous stage II adult diffuse small cleaved cell lymphoma
  • noncontiguous stage II adult immunoblastic large cell lymphoma
  • noncontiguous stage II adult lymphoblastic lymphoma
  • noncontiguous stage II grade 1 follicular lymphoma
  • noncontiguous stage II grade 2 follicular lymphoma
  • noncontiguous stage II grade 3 follicular lymphoma
  • noncontiguous stage II mantle cell lymphoma
  • noncontiguous stage II marginal zone lymphoma
  • noncontiguous stage II small lymphocytic lymphoma
  • previously treated myelodysplastic syndromes
  • recurrent adult acute lymphoblastic leukemia
  • recurrent adult acute myeloid leukemia
  • recurrent adult Burkitt lymphoma
  • recurrent adult Hodgkin lymphoma
  • recurrent adult diffuse large cell lymphoma
  • recurrent adult diffuse mixed cell lymphoma
  • recurrent adult diffuse small cleaved cell lymphoma
  • recurrent adult immunoblastic large cell lymphoma
  • recurrent adult lymphoblastic lymphoma
  • recurrent/refractory childhood Hodgkin lymphoma
  • recurrent childhood acute lymphoblastic leukemia
  • recurrent childhood acute myeloid leukemia
  • recurrent childhood large cell lymphoma
  • recurrent childhood lymphoblastic lymphoma
  • recurrent childhood rhabdomyosarcoma
  • recurrent childhood small noncleaved cell lymphoma
  • recurrent cutaneous T-cell non-Hodgkin lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • recurrent mantle cell lymphoma
  • recurrent marginal zone lymphoma
  • recurrent mycosis fungoides/Sezary syndrome
  • recurrent small lymphocytic lymphoma
  • refractory chronic lymphocytic leukemia
  • refractory hairy cell leukemia
  • refractory multiple myeloma
  • relapsing chronic myelogenous leukemia
  • secondary acute myeloid leukemia
  • secondary myelodysplastic syndromes
  • splenic marginal zone lymphoma
  • stage I multiple myeloma
  • stage II multiple myeloma
  • stage III adult Burkitt lymphoma
  • stage III adult Hodgkin lymphoma
  • stage III adult diffuse large cell lymphoma
  • stage III adult diffuse mixed cell lymphoma
  • stage III adult diffuse small cleaved cell lymphoma
  • stage III adult immunoblastic large cell lymphoma
  • stage III adult lymphoblastic lymphoma
  • stage III chronic lymphocytic leukemia
  • stage III grade 1 follicular lymphoma
  • stage III grade 2 follicular lymphoma
  • stage III grade 3 follicular lymphoma
  • stage III mantle cell lymphoma
  • stage III marginal zone lymphoma
  • stage III multiple myeloma
  • stage III small lymphocytic lymphoma
  • stage IV adult Burkitt lymphoma
  • stage IV adult Hodgkin lymphoma
  • stage IV adult diffuse large cell lymphoma
  • stage IV adult diffuse mixed cell lymphoma
  • stage IV adult diffuse small cleaved cell lymphoma
  • stage IV adult immunoblastic large cell lymphoma
  • stage IV adult lymphoblastic lymphoma
  • stage IV chronic lymphocytic leukemia
  • stage IV grade 1 follicular lymphoma
  • stage IV grade 2 follicular lymphoma
  • stage IV grade 3 follicular lymphoma
  • stage IV mantle cell lymphoma
  • stage IV marginal zone lymphoma
  • stage IV small lymphocytic lymphoma
  • childhood myelodysplastic syndromes
  • Neoplasms
  • Graft vs Host Disease
  • Leukemia
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma
  • Myelodysplastic Syndromes
  • Preleukemia
  • Myeloproliferative Disorders
  • Lymphoma, Large-Cell, Immunoblastic
  • Sarcoma
  • Myelodysplastic-Myeloproliferative Diseases

Name

Location

OHSU Knight Cancer InstitutePortland, Oregon  97239