Conditioning Treatment With Umbilical Cord Blood Transplant for Hematologic Malignancies
NCT ID: NCT01622556
Last Updated: 2014-02-11
Study Results
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.
TERMINATED
PHASE2
6 participants
INTERVENTIONAL
2012-01-31
2017-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Reduced Intensity Double Umbilical Cord Blood Transplantation
NCT01408563
Umbilical Cord Blood Stem Cell Transplant in Treating Patients With Hematologic Cancer or Other Disease
NCT00423826
Reduced Intensity Conditioning for Non-Malignant Disorders Undergoing UCBT, BMT or PBSCT
NCT01962415
Evaluating the Safety and Effectiveness of an Umbilical Cord Blood Stem Cell Transplant (BMT CTN 0604)
NCT00864227
Low-Dose Fludarabine, Busulfan, and Anti-Thymocyte Globulin Followed By Donor Umbilical Cord Blood Transplant in Treating Patients With Advanced Hematologic Cancer
NCT00301951
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Reduced Intensity Conditioning with UCB Transplant
Fludarabine
35 mg/m2 IV/day x 5 days
Busulfan
.8 mg/kg IV Q6h x 8 doses
Thymoglobulin
1.5 mg/kg/day x 3 days
Total Body Irradiation
150 cGy for 2 days
Umbilical Cord Blood
Two partially HLA-matched UCB units. Each unit must match at a minimum of 4 of 6 at HLA-A, -B, -DRB1 loci with the recipient.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Fludarabine
35 mg/m2 IV/day x 5 days
Busulfan
.8 mg/kg IV Q6h x 8 doses
Thymoglobulin
1.5 mg/kg/day x 3 days
Total Body Irradiation
150 cGy for 2 days
Umbilical Cord Blood
Two partially HLA-matched UCB units. Each unit must match at a minimum of 4 of 6 at HLA-A, -B, -DRB1 loci with the recipient.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Patients must have a diagnosis of one of the following:
* Chronic Myeloid Leukemia
* Acute Myeloid Leukemia
* Acute Lymphoblastic Leukemia
* Hodgkin's Disease
* Non-Hodgkins Lymphoma
* Myelodysplastic Syndromes
* Myeloproliferative Disorder
Patients must have adequate visceral organ function
* Patients must furnish written informed consent and HIPAA authorization for release of personal health information.
* Patients must be able to understand the requirements of the study, abide by the study restrictions, and agree to return for the required assessments.
Exclusion Criteria
* Patients who are pregnant are ineligible.
* Patients are ineligible if they have received cumulative chemotherapy doses in excess of: carmustine (BCNU) 400 mg/m2, and/or a cumulative anthracycline exposure in excess of 550 mg/m2 doxorubicin (Adriamycin®) unless gated-pool radionuclide cardiac scan shows greater than/equal to 45% ejection fraction.
Patients who are HIV or HTLV-I, -II antibody sero-positive are ineligible.
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Virginia
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Amer Beitinjaneh, MD
Assistant Professor of Medicine, Medical Director Stem Cell Transplant Unit
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Amer M Beitinjaneh, MD
Role: PRINCIPAL_INVESTIGATOR
University of Virginia
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Virginia
Charlottesville, Virginia, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
15954 UCB-2011
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.