Clinical trial NCT01622556: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Hematologic Malignancies
Keywords: Chronic Myeloid Leukemia
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Non-Hodgkins Lymphoma
Hodgkin's Disease
Myelodysplastic Syndromes
Myeloproliferative Disorder
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2012-06-19
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Event Free Survival
timeFrame: 180 days
Secondary outcomes:
measure: Transplant Engraftment
timeFrame: Day 42
measure: Incidence of Graft-versus-host disease (GVHD)
timeFrame: 1 year
measure: Time course for peripheral blood chimerism.
timeFrame: 56 days
measure: Incidence of secondary lymphoproliferative diseases
timeFrame: 6 months
measure: Incidence of disease recurrence
timeFrame: Up to two years
measure: Incidence of serious infectious complications
timeFrame: 1 year
measure: Overall Survivals
timeFrame: 60 months
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: University of Virginia
name: Amer M Beitinjaneh, MD
role: PRINCIPAL_INVESTIGATOR
References: