NCT01630564

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

Phase I Study of Ex Vivo Expanded Donor Cord Blood T-Lymphocyte Infusion in Post-Transplant Relapsed Patients

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 6 Months
• Healthy volunteers: Not accepted

Summary

This phase I trial studies the side effects and best dose of donor cord blood T-cells after stem cell transplant in treating patients with relapsed hematological malignancies. After umbilical cord blood transplant, stem cells are collected from the donor's cord blood and stored. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by treatment. Removing the T cells and treating them in the laboratory before infusing them in the patient may also help boost the patient's immune system.

Detailed description

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.

Conditions

• Hematopoietic and Lymphoid Cell Neoplasm

Interventions

Type	Name	Description
BIOLOGICAL	Aldesleukin	Undergo ex-vivo-expanded umbilical cord blood progenitor cell donor T-cell infusion with aldesleukin
PROCEDURE	Ex Vivo-Expanded Cord Blood Progenitor Cell Infusion	Undergo ex-vivo-expanded umbilical cord blood progenitor cell donor T-cell infusion with aldesleukin
BIOLOGICAL	Umbilical Cord Blood-Derived Lymphocyte Therapy	Undergo ex-vivo-expanded umbilical cord blood progenitor cell donor T-cell infusion with aldesleukin

Timeline

• Start date: 2013-03-11
• Primary completion: 2018-05-30
• Completion: 2018-05-30
• First posted: 2012-06-28
• Last updated: 2018-11-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study