Conditioning Treatment With Umbilical Cord Blood Transplant for Hematologic Malignancies

• Sponsor: University of Virginia (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01622556
• Collaborator: (none)
• Enrollment: 6
• Location: 1
• Arm: 1
• Duration (Months): 60
• Patients Per Site Per Month: 0.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hematologic Malignancies	Drug: Fludarabine; Drug: Busulfan; Drug: Thymoglobulin; Radiation: Total Body Irradiation; Biological: Umbilical Cord Blood	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 6 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: Jan 1, 2012
• Anticipated Primary Completion Date: Feb 1, 2014
• Anticipated Study Completion Date: Jan 1, 2017

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Event Free Survival [180 days]

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

Secondary Outcome Measures

1. Transplant Engraftment [Day 42]

   Number of patients with successful UCB engraftment.

2. Incidence of Graft-versus-host disease (GVHD) [1 year]

   Number of patients that experience acute or chronic GVHD.

3. Time course for peripheral blood chimerism. [56 days]

   Percent of patients with >95% donor chimerism.

4. Incidence of secondary lymphoproliferative diseases [6 months]

   Number of patients with secondary lymphoproliferative diseases.

5. Incidence of disease recurrence [Up to two years]

   Number of patients experience disease recurrence.

6. Incidence of serious infectious complications [1 year]

   Number of patients experiencing serious infectious complications.

7. Overall Survivals [60 months]

   Number of patient with overall event free survival and overall survival distributions.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Virginia	Charlottesville	Virginia	United States	22908

Sponsors and Collaborators

• University of Virginia

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Amer Beitinjaneh, MD, Assistant Professor of Medicine, Medical Director Stem Cell Transplant Unit, University of Virginia
• ClinicalTrials.gov Identifier: NCT01622556
• Other Study ID Numbers: 15954 UCB-2011
• First Posted: Jun 19, 2012
• Last Update Posted: Feb 11, 2014
• Last Verified: Feb 1, 2014

• Keywords provided by Amer Beitinjaneh, MD, Assistant Professor of Medicine, Medical Director Stem Cell Transplant Unit, University of Virginia: Chronic Myeloid Leukemia; Acute Myeloid Leukemia; Acute Lymphoblastic Leukemia; Non-Hodgkins Lymphoma; Hodgkin's Disease; Myelodysplastic Syndromes; Myeloproliferative Disorder
• Additional relevant MeSH terms: Neoplasms; Hematologic Neoplasms; Fludarabine; Busulfan; Thymoglobulin

Study Results

No Results Posted as of Feb 11, 2014