Donor Cord Blood T-Cell Infusion After Stem Cell Transplant in Treating Patients With Relapsed Hematological Malignancies

PRIMARY OBJECTIVES:

I. To evaluate the safety and maximum tolerated dose (MTD) of infusion of ex vivo expanded
cord blood T cells (CLI), in cord blood (CB) transplant recipients with relapsed
hematological malignancies.

SECONDARY OBJECTIVES:

I. To determine the complete remission rate and overall response as a result of CLI infusion.

II. To determine the effect of CLI infusion on the chimerism. III. To evaluate the incidence
rate and grade of acute graft-versus-host disease (GvHD) after CLI infusion.

IV. To determine the disease-free survival, cytopenia rate, relapse incidence after CLI
infusion.

OUTLINE: This is a dose-escalation study of ex vivo-expanded T-cells.

Patients undergo ex vivo-expanded umbilical cord blood progenitor cell donor T cell infusion
with aldesleukin 11-14 days after T-cell co-stimulation begins.

After completion of study treatment, patients are followed up for 100 days.

Inclusion Criteria:

- Umbilical cord blood (UCB) recipients with underlying hematological malignancies
presenting with post-transplant relapse and have available approximately 400
microliter to 1 ml aliquots or CB wash from previous transplant

- UCB recipients with T-cell and/or overall chimerism value of less than 80%, in absence
of relapse and have available approximately 400 microliter to 1 ml aliquots or CB wash
from previous transplant

- Performance score of at least 80% by Karnofsky or performance status (PS) < 3 (Eastern
Cooperative Oncology Group [ECOG]) (age >= 12 years), or Lansky Play-performance scale
of at least 60% or greater (age < 12 years)

- Negative beta human chorionic gonadotropin (HCG) or urine test in females of
childbearing potential defined as not post-menopausal for 12 months or no previous
surgical sterilization and willing to use an effective contraceptive measure while on
the study

- Patient or patient's legal representative, parent(s) or guardian able to sign informed
consent

Exclusion Criteria:

- Human immunodeficiency virus (HIV) positive (due to the extreme immunosuppressive
nature of allogeneic stem cell transplant)

- Patients with active (untreated) central nervous system (CNS) disease

- Any active GVHD

- Active invasive infections

- Pregnant or breast-feeding