Conditioning Treatment With Umbilical Cord Blood Transplant for Hematologic Malignancies

Phase 2

Terminated

• Conditions: Hematologic Malignancies
• Interventions: Drug: Fludarabine; Drug: Busulfan; Drug: Thymoglobulin; Radiation: Total Body Irradiation; Biological: Umbilical Cord Blood

• Registration Number: NCT01622556
• Lead Sponsor: University of Virginia

Brief Summary

This is a phase II study to assess the day 180 event free and overall survival after administration of a specified combination of fludarabine, busulfan, Total Body Irradiation (TBI), and thymoglobulin reduced intensity conditioning and 2 unit UCB stem cell transplant in a single institution setting in patients with hematologic malignancies for whom allogeneic transplantation is indicated.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-06-08
• Study First Submitted QC: 2012-06-14
• Study First Posted: 2012-06-19
• Status Verified: 2014-02
• Primary Completion: 2014-02
• Last Update Submitted: 2014-02-10
• Last Update Posted: 2014-02-11
• Study Completion: 2017-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

Subjects 18-70 years old. ECOG 0-2

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 have a histocompatible sibling-matched donor age 18 to 65 years in good health who is willing to donate stem cells are ineligible.
• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Reduced Intensity Conditioning with UCB Transplant	Thymoglobulin	-
Reduced Intensity Conditioning with UCB Transplant	Total Body Irradiation	-
Reduced Intensity Conditioning with UCB Transplant	Umbilical Cord Blood	-
Reduced Intensity Conditioning with UCB Transplant	Busulfan	-
Reduced Intensity Conditioning with UCB Transplant	Fludarabine	-

Primary Outcome Measures

Name	Time	Method
Event Free Survival	180 days	Number of subjects surviving with no events at 180 days post transplantation (Day 0).

Secondary Outcome Measures

Name	Time	Method
Transplant Engraftment	Day 42	Number of patients with successful UCB engraftment.
Incidence of Graft-versus-host disease (GVHD)	1 year	Number of patients that experience acute or chronic GVHD.
Time course for peripheral blood chimerism.	56 days	Percent of patients with \>95% donor chimerism.
Incidence of secondary lymphoproliferative diseases	6 months	Number of patients with secondary lymphoproliferative diseases.
Incidence of disease recurrence	Up to two years	Number of patients experience disease recurrence.
Incidence of serious infectious complications	1 year	Number of patients experiencing serious infectious complications.
Overall Survivals	60 months	Number of patient with overall event free survival and overall survival distributions.

Trial Locations

Locations (1)

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States