Conditioning Treatment With Umbilical Cord Blood Transplant for Hematologic Malignancies

Hematologic Malignancies Clinical Trial

Official title:

Phase II Trial of Reduced Intensity Conditioning (RIC) and Allogeneic Transplantation of Umbilical Cord Blood (UCB) From Unrelated Donors in Patients With Hematologic Malignancies

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01622556
• Other study ID #: 15954 UCB-2011
• Status: Terminated
• Phase: Phase 2
• First received: June 8, 2012
• Last updated: February 10, 2014
• Start date: January 2012
• Est. completion date: January 2017

Study information

• Verified date: February 2014
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: January 2017
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hematologic Malignancies
• Neoplasms

Intervention

Drug:
• 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

Radiation:
• Total Body Irradiation
150 cGy for 2 days

Biological:
• 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.

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Event Free Survival	Number of subjects surviving with no events at 180 days post transplantation (Day 0).	180 days
Secondary	Transplant Engraftment	Number of patients with successful UCB engraftment.	Day 42
Secondary	Incidence of Graft-versus-host disease (GVHD)	Number of patients that experience acute or chronic GVHD.	1 year
Secondary	Time course for peripheral blood chimerism.	Percent of patients with >95% donor chimerism.	56 days
Secondary	Incidence of secondary lymphoproliferative diseases	Number of patients with secondary lymphoproliferative diseases.	6 months
Secondary	Incidence of disease recurrence	Number of patients experience disease recurrence.	Up to two years
Secondary	Incidence of serious infectious complications	Number of patients experiencing serious infectious complications.	1 year
Secondary	Overall Survivals	Number of patient with overall event free survival and overall survival distributions.	60 months