Unrelated Donor Stem Cell Transplantation

Not Applicable

Completed

• Conditions: Acute Lymphoblastic Leukemia; Severe Aplastic Anemia; Chronic Myelogenous Leukemia; Non-Hodgkin's Lymphoma; Small Lymphocytic Lymphoma; Chronic Lymphocytic Leukemia; Acute Myelogenous Leukemia; Hodgkin's Lymphoma; Large Granulocytic Leukemia; Paroxysmal Nocturnal Hemoglobinuria
• Interventions: Procedure: Allogeneic transplantation

• Registration Number: NCT01364363
• Lead Sponsor: Scripps Health

Brief Summary

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.

Detailed Description

same

Study Timeline

• Study Start: 2005-03
• Study First Submitted: 2011-04-04
• Study First Submitted QC: 2011-06-01
• Study First Posted: 2011-06-02
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-21
• Last Update Posted: 2022-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BEAM (BCNU, etoposide, Ara-C, melphalan)	Allogeneic transplantation	Lymphomas, Hodgkin's Disease
Busulfan/Cytoxan	Allogeneic transplantation	Acute Leukemia, Myelodysplastic syndromes, Chronic Leukemias, Bone Marrow Failure states
Total Lymphoid Irradiation	Allogeneic transplantation	For patients with Multiple Myeloma, or prior autologous transplantation, or age in excess of 55
FLAG (fludarabine, Ara-C, G-CSF)	Allogeneic transplantation	For patients undergoing a second allogeneic transplant
Total Body Irradiation/VP16	Allogeneic transplantation	Acute Leukemias, Myelodysplastic syndromes
Cytoxan/Total Body Irradiation	Allogeneic transplantation	Chronic Leukemias, Bone Marrow Failure States, Lymphomas, Hodgkin's Disease
Cladribine/Melphalan	Allogeneic transplantation	For patients with Multiple Myeloma, or prior autologous transplantation, or age in excess of 55

Primary Outcome Measures

Name	Time	Method
Bone Marrow and Peripheral Blood Chimerism	365 days post-transplant	Percent of donor and host cells in peripheral blood and bone marrow will be measured by short tandem repeat (STR) testing and/or standard cytogenetic testing.

Trial Locations

Locations (1)

Scripps Green Hospital; 🇺🇸 La Jolla, California, United States