Fucosylated T Cells for Graft Versus Host Disease (GVHD) Prevention

Summary

Any time the words "you," "your," "I," or "me" appear, it is meant to apply to the potential participant.

T-cells are white blood cells that are important to the immune system. The T cells for this study (called regulatory T-cells, or Tregs) will be from a donor who is not related to you. Before the Tregs are given to you, they may be changed in the laboratory to make use of sugar that is found in small amounts in blood cells through a process called fucosylation. They are then called fucosylated Tregs. Adding more sugars to the Tregs in the laboratory is designed to help the Tregs find their way faster to the bone marrow, which may help low blood counts to recover faster.

The goal of this clinical research study is to learn if it is safe and practical to give fucosylated Tregs to patients who will receive a matched related donor (MRD), a matched unrelated donor (MUD), or cord blood transplant. Researchers also want to learn if these Tregs may prevent or reduce the effects of graft-versus host disease (GVHD). GVHD can result from a reaction of the transplanted cord blood cells against certain tissues in the body.

This is an investigational study. Fucosylation of Tregs is not an FDA-approved process. It is currently being used for research purposes only. Fludarabine, melphalan, cyclophosphamide and rituximab are FDA approved and commercially available to be given to patients with leukemia or lymphoma having a cord blood transplant. Total body irradiation is delivered using FDA-approved and commercially available methods.

Up to 47 patients will take part in this study. All will be enrolled at MD Anderson.

Conditions

• Leukemia
• Lymphoma

Interventions

DRUG

Rituximab

375 mg/m2 by vein on Day -12 for for participants with CD20+ malignancies.

DRUG

Fludarabine

40 mg/m2 by vein on Days -8 to -5.

DRUG

Cyclophosphamide

50 mg/kg by vein on Day -8.

RADIATION

Total Body Radiation

2 Gy delivered on Day -4.

PROCEDURE

Fucosylated Regulatory T Cells

Phase I: Participants treated at cell dose level 1: 1 x 10\^6/kg Fucosylated T-reg cells on Day -1. Phase II: Participants treated at cell dose level 2: 1 x 10\^7/kg Fucosylated T-reg cells on Day -1.

PROCEDURE

Cord Blood Infusions

Cord blood transplant, MRD, or MUD infused on Day 0.

DRUG

Mycophenolate mofetil

15 mg/kg (actual body weight with a maximum dose of 1 gram twice daily) by vein or mouth from Day -3 to Day +100 in the absence of GVHD.

DRUG

Sirolimus

12 mg by mouth load followed by 4 mg by mouth daily from Day -3 to Day +180 in the absence of GVHD.

PROCEDURE

Bone Marrow Aspiration

Bone marrow aspiration performed at 1, 3, 6, and 12 months after transplant to check status of disease.

DRUG

G-CSF

5 mcg/kg/day subcutaneously beginning on D+0, and continuing until absolute neutrophil count (ANC) is \> 500 x 10/L for 3 consecutive days.

PROCEDURE

Non-Fucosylated Regulatory T Cells

Phase I: Participants treated at cell dose level 1: 1 x 10\^7/kg Non-Fucosylated T-reg cells on Day -1. Phase II: Participants treated at cell dose level 2: 1 x 10\^7/kg Non-Fucosylated T-reg cells on Day -1.

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Cancer Prevention Research Institute of Texas

  collaborator OTHER

• M.D. Anderson Cancer Center

  lead OTHER

Principal Investigators

• Richard E. Champlin, BS, MD · M.D. Anderson Cancer Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-07-30

Primary Completion

2020-10-06

Completion

2020-10-06

FDA Drug

Yes

Countries

• United States

Study Locations