Unrelated Donor Stem Cell Transplantation

Scripps Health

Status: Completed

Conditions: Myeloproliferative Syndromes; Acute Myelogenous Leukemia; Small Lymphocytic Lymphoma; Chronic Myelogenous Leukemia; Large Granulocytic Leukemia; Myelodysplastic Syndromes; Severe Aplastic Anemia; Hodgkin's Lymphoma; Multiple Myeloma; Paroxysmal Nocturnal Hemoglobinuria; Non-Hodgkin's Lymphoma; Chronic Lymphocytic Leukemia; Acute Lymphoblastic Leukemia

Treatments: Procedure: Allogeneic transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT01364363

SIRB#13-6190

Details and patient eligibility

About

The purpose of this study is to provide an opportunity for patients with malignancies or bone marrow failure states who lack a suitable sibling donor to undergo allogeneic hematopoietic progenitor cell transplantation using cells from unrelated individuals or cord blood registries.

Full description

same

Enrollment: 64 patients

Sex: All

Ages: 18 to 69 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• > 18 years of Age
• < 70 years
• ECOG performance status 0, 1 or 2
• Left Ventricular Ejection Fraction > 30%
• Creatinine clearance > 40ml/min
• Transaminases < 2X normal
• Total bilirubin < 2X normal
• HIV seronegativity
• Weight < 70kg for cord blood transplantation
• Ability to cover the cost of the transplant, necessary medications, and transportation/housing.
• Caregiver must be available while outpatient

Exclusion criteria

• Greater than one antigen mismatch at HLA-A, B, C or DR plus one allele mismatch at HLA-A, B, C or DR

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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64 participants in 7 patient groups

Total Body Irradiation/VP16

Other group

Description:

Acute Leukemias, Myelodysplastic syndromes

Treatment:

Procedure: Allogeneic transplantation

Cytoxan/Total Body Irradiation

Other group

Description:

Chronic Leukemias, Bone Marrow Failure States, Lymphomas, Hodgkin's Disease

Treatment:

Procedure: Allogeneic transplantation

Busulfan/Cytoxan

Other group

Description:

Acute Leukemia, Myelodysplastic syndromes, Chronic Leukemias, Bone Marrow Failure states

Treatment:

Procedure: Allogeneic transplantation

BEAM (BCNU, etoposide, Ara-C, melphalan)

Other group

Description:

Lymphomas, Hodgkin's Disease

Treatment:

Procedure: Allogeneic transplantation

Total Lymphoid Irradiation

Other group

Description:

For patients with Multiple Myeloma, or prior autologous transplantation, or age in excess of 55

Treatment:

Procedure: Allogeneic transplantation

Cladribine/Melphalan

Other group

Description:

For patients with Multiple Myeloma, or prior autologous transplantation, or age in excess of 55

Treatment:

Procedure: Allogeneic transplantation

FLAG (fludarabine, Ara-C, G-CSF)

Other group

Description:

For patients undergoing a second allogeneic transplant

Treatment:

Procedure: Allogeneic transplantation