Unrelated Donor Stem Cell Transplantation

NCT ID: NCT01364363

Last Updated: 2022-11-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2015-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

same

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Total Body Irradiation/VP16

Acute Leukemias, Myelodysplastic syndromes

Group Type OTHER

Allogeneic transplantation

Intervention Type PROCEDURE

Allogeneic transplantation with matched unrelated donors

Cytoxan/Total Body Irradiation

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

Group Type OTHER

Allogeneic transplantation

Intervention Type PROCEDURE

Allogeneic transplantation with matched unrelated donors

Busulfan/Cytoxan

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

Group Type OTHER

Allogeneic transplantation

Intervention Type PROCEDURE

Allogeneic transplantation with matched unrelated donors

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

Lymphomas, Hodgkin's Disease

Group Type OTHER

Allogeneic transplantation

Intervention Type PROCEDURE

Allogeneic transplantation with matched unrelated donors

Total Lymphoid Irradiation

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

Group Type OTHER

Allogeneic transplantation

Intervention Type PROCEDURE

Allogeneic transplantation with matched unrelated donors

Cladribine/Melphalan

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

Group Type OTHER

Allogeneic transplantation

Intervention Type PROCEDURE

Allogeneic transplantation with matched unrelated donors

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

For patients undergoing a second allogeneic transplant

Group Type OTHER

Allogeneic transplantation

Intervention Type PROCEDURE

Allogeneic transplantation with matched unrelated donors

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Allogeneic transplantation

Allogeneic transplantation with matched unrelated donors

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

MUD transplant

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Scripps Health

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jeffrey W. Andrey, MD

Role: PRINCIPAL_INVESTIGATOR

Scripps Clinic Medical Group

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Scripps Green Hospital

La Jolla, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SIRB#13-6190

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Bone Marrow Grafting for Leukemia and Lymphoma
NCT00186147 ENROLLING_BY_INVITATION