Conditioning Treatment With Umbilical Cord Blood Transplant for Hematologic Malignancies

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

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.

Study Overview

• Status: Terminated
• Conditions: Hematologic Malignancies
• Intervention / Treatment: Drug: Fludarabine; Drug: Busulfan; Drug: Thymoglobulin; Radiation: Total Body Irradiation; Biological: Umbilical Cord Blood

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Reduced Intensity Conditioning with UCB Transplant	Drug: Fludarabine; 35 mg/m2 IV/day x 5 days; Drug: Busulfan; .8 mg/kg IV Q6h x 8 doses; Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Event Free Survival	Number of subjects surviving with no events at 180 days post transplantation (Day 0).	180 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Virginia
• Investigators: Principal Investigator: Amer M Beitinjaneh, MD, University of Virginia

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Anticipated): February 1, 2014
• Study Completion (Anticipated): January 1, 2017

Study Registration Dates

• First Submitted: June 8, 2012
• First Submitted That Met QC Criteria: June 14, 2012
• First Posted (Estimate): June 19, 2012

Study Record Updates

• Last Update Posted (Estimate): February 11, 2014
• Last Update Submitted That Met QC Criteria: February 10, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: Acute Myeloid Leukemia; Acute Lymphoblastic Leukemia; Myelodysplastic Syndromes; Chronic Myeloid Leukemia; Non-Hodgkins Lymphoma; Hodgkin's Disease; Myeloproliferative Disorder
• Additional Relevant MeSH Terms: Neoplasms by Site; Hematologic Diseases; Neoplasms; Hematologic Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Antineoplastic Agents, Alkylating; Alkylating Agents; Myeloablative Agonists; Fludarabine; Busulfan; Thymoglobulin
• Other Study ID Numbers: 15954 UCB-2011