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Conditioning Treatment With Umbilical Cord Blood Transplant for Hematologic Malignancies

Primary Purpose

Hematologic Malignancies

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Fludarabine
Busulfan
Thymoglobulin
Total Body Irradiation
Umbilical Cord Blood
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hematologic Malignancies focused on measuring Chronic Myeloid Leukemia, Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Non-Hodgkins Lymphoma, Hodgkin's Disease, Myelodysplastic Syndromes, Myeloproliferative Disorder

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Virginia

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Reduced Intensity Conditioning with UCB Transplant

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Transplant Engraftment
Number of patients with successful UCB engraftment.
Incidence of Graft-versus-host disease (GVHD)
Number of patients that experience acute or chronic GVHD.
Time course for peripheral blood chimerism.
Percent of patients with >95% donor chimerism.
Incidence of secondary lymphoproliferative diseases
Number of patients with secondary lymphoproliferative diseases.
Incidence of disease recurrence
Number of patients experience disease recurrence.
Incidence of serious infectious complications
Number of patients experiencing serious infectious complications.
Overall Survivals
Number of patient with overall event free survival and overall survival distributions.

Full Information

First Posted
June 8, 2012
Last Updated
February 10, 2014
Sponsor
University of Virginia
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1. Study Identification

Unique Protocol Identification Number
NCT01622556
Brief Title
Conditioning Treatment With Umbilical Cord Blood Transplant for Hematologic Malignancies
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Terminated
Study Start Date
January 2012 (undefined)
Primary Completion Date
February 2014 (Anticipated)
Study Completion Date
January 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematologic Malignancies
Keywords
Chronic Myeloid Leukemia, Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Non-Hodgkins Lymphoma, Hodgkin's Disease, Myelodysplastic Syndromes, Myeloproliferative Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Reduced Intensity Conditioning with UCB Transplant
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Fludarabine
Intervention Description
35 mg/m2 IV/day x 5 days
Intervention Type
Drug
Intervention Name(s)
Busulfan
Intervention Description
.8 mg/kg IV Q6h x 8 doses
Intervention Type
Drug
Intervention Name(s)
Thymoglobulin
Intervention Description
1.5 mg/kg/day x 3 days
Intervention Type
Radiation
Intervention Name(s)
Total Body Irradiation
Intervention Description
150 cGy for 2 days
Intervention Type
Biological
Intervention Name(s)
Umbilical Cord Blood
Intervention Description
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.
Primary Outcome Measure Information:
Title
Event Free Survival
Description
Number of subjects surviving with no events at 180 days post transplantation (Day 0).
Time Frame
180 days
Secondary Outcome Measure Information:
Title
Transplant Engraftment
Description
Number of patients with successful UCB engraftment.
Time Frame
Day 42
Title
Incidence of Graft-versus-host disease (GVHD)
Description
Number of patients that experience acute or chronic GVHD.
Time Frame
1 year
Title
Time course for peripheral blood chimerism.
Description
Percent of patients with >95% donor chimerism.
Time Frame
56 days
Title
Incidence of secondary lymphoproliferative diseases
Description
Number of patients with secondary lymphoproliferative diseases.
Time Frame
6 months
Title
Incidence of disease recurrence
Description
Number of patients experience disease recurrence.
Time Frame
Up to two years
Title
Incidence of serious infectious complications
Description
Number of patients experiencing serious infectious complications.
Time Frame
1 year
Title
Overall Survivals
Description
Number of patient with overall event free survival and overall survival distributions.
Time Frame
60 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amer M Beitinjaneh, MD
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States

12. IPD Sharing Statement

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Conditioning Treatment With Umbilical Cord Blood Transplant for Hematologic Malignancies

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