Conditioning Treatment With Umbilical Cord Blood Transplant for Hematologic Malignancies

University of Virginia

Status and phase

Terminated

Phase 2

Conditions

Hematologic Malignancies

Treatments

Drug: Busulfan

Drug: Thymoglobulin

Drug: Fludarabine

Biological: Umbilical Cord Blood

Radiation: Total Body Irradiation

Study type

Interventional

Funder types

Other

Identifiers

NCT01622556

15954 UCB-2011

Details and patient eligibility

About

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.

Enrollment

6 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No 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.