Infusion of Expanded Cord Blood T Cells

Summary

The goal of this clinical research study is to learn if treating umbilical cord blood with growth factors before a transplant can help to improve the body's ability to accept the cord blood transplants.

Conditions

• Stem Cell Transplantation
• Leukemia
• Lymphoma
• Pediatric Disorders

Interventions

RADIATION

Total Body Irradiation (TBI)

3 Gy of radiation on Days -7,-6, -5 and -4.

DRUG

Melphalan

140 mg/m\^2 by vein over 30 minutes as a single dose on Day -8

DRUG

Thiotepa

10 mg/kg by vein over 4 hours as a single dose on Day -7

DRUG

Fludarabine

40 mg/m\^2 by vein over about 30 minutes 1 time each day on Days -6 through -3.

DRUG

Rituximab

Regimen 1: 375 mg/m\^2 may be given by vein over 4 - 6 hours on Day -9 if needed Regimen 2: 375 mg/m\^2 may be given by vein over 4 - 6 hours on Day -8 if needed

DRUG

Etoposide

60 mg/m\^2 by vein over 1-2 hours as a single dose on Day -3.

DRUG

Anti-thymocyte globulin (ATG)

Regimen 1: 1.25 and 1.75 mg/kg by vein over 4-6 hours on the Days -4 and -3. Regimen 2: 0.5, 1.0 and 1.5 mg/kg by vein over 4-6 hours on respective Days -3, -2, and -1.

DRUG

Mycophenolate Mofetil (MMF)

15 mg/kg pills twice a day starting on day -3, and continued until Day 100+ after transplant (1 gram may be given by vein if necessary).

DRUG

Tacrolimus

0.03 mg/kg by vein Day -2 as 24 hour continuous infusion for several weeks. After stem cell transplant, tacrolimus given by mouth 2 times a day for up to 6 months.

PROCEDURE

Cord Blood Infusion

Cord blood infusion of larger portion through vein using Central Venous Catheter (CVC) on Day 0.

DRUG

G-CSF

5 mcg/kg day subcutaneously (may round up to the next vial) beginning on day +1 and continuing till absolute neutrophil count is \> 2.5 x 10e\^9/L.

PROCEDURE

Ex vivo expanded T cell Infusion

Infusion by vein of treated cord blood beginning dose of 1 x 10e\^5 T cells/kg on Day 14+.

Sponsors & Collaborators

• M.D. Anderson Cancer Center

  lead OTHER

Principal Investigators

• Laura L. Worth, MD, PHD · UT MD Anderson Cancer Center

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Max Age

55 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-09-30

Primary Completion

2011-09-30

Completion

2011-09-30