Unrelated Donor Stem Cell Transplantation

Sponsor

Scripps Health (Other)

Overall Status

Recruiting

CT.gov ID

NCT01364363

Collaborator

(none)

Enrollment

Location

Arms

214

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Severe Aplastic Anemia Paroxysmal Nocturnal Hemoglobinuria Acute Myelogenous Leukemia Acute Lymphoblastic Leukemia Myelodysplastic Syndromes Myeloproliferative Syndromes Chronic Myelogenous Leukemia Hodgkin's Lymphoma Non-Hodgkin's Lymphoma Multiple Myeloma Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma Large Granulocytic Leukemia	Procedure: Allogeneic transplantation	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Non-Randomized

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Allogeneic Hematopoietic Progenitor Cell Transplantation From Unrelated Donors

Study Start Date :

Mar 1, 2005

Anticipated Primary Completion Date :

Jan 1, 2021

Anticipated Study Completion Date :

Jan 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Bone Marrow and Peripheral Blood Chimerism [30 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.
Bone Marrow and Peripheral Blood Chimerism [100 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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 69 Years

Sexes Eligible for Study:

All

Accepts 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