Completed

NCT Number: NCT00003538

Prevention of Graft-Versus-Host Disease in Patients Undergoing Bone Marrow Transplantation

RATIONALE: Bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill tumor cells. Sometimes the transplanted cells can make an immune response against the body's normal tissues. Stem cells that have been treated in the laboratory to remove lymphocytes may prevent this from happening.

PURPOSE: Clinical trial to prevent graft-versus-host disease in patients undergoing bone marrow transplantation.

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Key information

Conditions

Cancer Adnexal Diseases Anemia Blast Crisis Blood Protein Disorders Bone Marrow Diseases Breast Diseases Breast Neoplasms Burkitt Lymphoma Carcinogenesis Carcinoma Carcinoma, Ovarian Epithelial Cardiovascular Diseases Cell Transformation, Neoplastic Chronic Disease Congenital, Hereditary, and Neonatal Diseases and Abnormalities DNA Virus Infections Dendritic Cell Sarcoma, Interdigitating Disease Attributes Endocrine Gland Neoplasms Endocrine System Diseases Epstein-Barr Virus Infections Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Genital Diseases Genital Diseases, Female Genital Diseases, Male Genital Neoplasms, Female Genital Neoplasms, Male Gonadal Disorders Graft vs Host Disease Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Herpesviridae Infections Histiocytic Disorders, Malignant Histiocytosis Hodgkin Disease Immune System Diseases Immunoblastic Lymphadenopathy Immunoproliferative Disorders Infections Kidney Diseases Kidney Neoplasms Leukemia Leukemia, B-Cell Leukemia, Biphenotypic, Acute Leukemia, Hairy Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Leukemia, Myeloid, Accelerated Phase Leukemia, Myeloid, Acute Leukemia, Myeloid, Chronic-Phase Leukemia, Myelomonocytic, Chronic Leukemia, Prolymphocytic Lymphadenopathy Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, B-Cell, Marginal Zone Lymphoma, Follicular Lymphoma, Large B-Cell, Diffuse Lymphoma, Large-Cell, Anaplastic Lymphoma, Large-Cell, Immunoblastic Lymphoma, Mantle-Cell Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoproliferative Disorders Male Urogenital Diseases Multiple Myeloma Myelodysplastic Syndromes Myelodysplastic-Myeloproliferative Diseases Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Complex and Mixed Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neoplasms, Plasma Cell Neoplastic Processes Neoplastic Syndromes, Hereditary Neuroblastoma Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Neuroectodermal Tumors, Primitive, Peripheral Ovarian Diseases Ovarian Neoplasms Paraproteinemias Pathologic Processes Pathological Conditions, Signs and Symptoms Precursor Cell Lymphoblastic Leukemia-Lymphoma Precursor T-Cell Lymphoblastic Leukemia-Lymphoma Recurrence Skin Diseases Skin and Connective Tissue Diseases Testicular Diseases Testicular Neoplasms Tumor Virus Infections Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Vascular Diseases Virus Diseases Waldenstrom Macroglobulinemia Wilms Tumor

Age range

Up to 65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

About this study

OBJECTIVES:

Determine whether stem cell augmented, elutriated grafts prevent graft versus host disease in patients undergoing allogeneic bone marrow transplantation.

OUTLINE: Patients receive elutriated CD34+ augmented donor bone marrow on day 0.

Bone marrow samples are obtained before day 100, around 6 months, and 1 year after transplant.

PROJECTED ACCRUAL: Not specified

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

DISEASE CHARACTERISTICS:

Histologically confirmed diagnosis of one the following:

Acute myelogenous leukemia in CR1, ER1, CR2, ER2, CR3
Acute lymphocytic leukemia in CR1, ER1, CR2, ER2, CR3
Non-Hodgkin's lymphoma
Hodgkin's lymphoma
Multiple myeloma with no more than 12 months of prior alkylator based chemotherapy
Myelodysplastic syndrome (MDS)
Acute leukemia arising out of MDS
Primary resistant acute leukemia
Chronic myelomonocytic leukemia
Aplastic anemia (40 years of age and over)
Solid tumor malignancy (germ cell, sarcoma, breast, etc.)
Genetic disorders or inborn errors of metabolism as defined by preparative regimen protocol
Chronic myelogenous leukemia
Must meet all inclusion criteria specified by the respective preparative regimen protocol
No aplastic anemia under 40 years of age or myelofibrosis

PATIENT CHARACTERISTICS:

Age:

0.5 to 65

Performance status:

Not specified

Life expectancy:

Not specified

Hematopoietic:

Not specified

Hepatic:

Not specified

Renal:

Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy:

No prior red blood cell or platelet transfusions from a sibling donor

Chemotherapy:

Not specified

Endocrine therapy:

Not specified

Radiotherapy:

Not specified

Surgery:

Not specified

Treatment and study plan

graft versus host disease prophylaxis/therapy

Biological

allogeneic bone marrow transplantation

Procedure

Sponsors and collaborators

Lead sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Other

Collaborators

National Cancer Institute (NCI)

Registry information

Official study title

Stem Cell Augmented, Elutriated Grafts for Allogeneic Bone Marrow Transplantation

Important dates

Study start: 1997
Primary completion: 2004
Study completion: 2004
First posted: Jan 27, 2003
Registry last updated: May 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed