T-Regulatory Cell Infusion Post Umbilical Cord Blood Transplant in Patients With Advanced Hematologic Cancer

Summary

RATIONALE: Giving chemotherapy, such as fludarabine and cyclophosphamide, and total-body irradiation before a donor umbilical cord blood transplant helps stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Giving an infusion of the donor's T-regulatory cells after the transplant may decrease this effect. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. However, the donor immune system may also react against the recipient's tissues (graft-versus-host disease).

PURPOSE: This phase I trial is studying the side effects and best dose of donor T-regulatory cells after an umbilical cord blood transplant in treating patients with advanced hematologic cancer or other disorder.

Conditions

• Leukemia
• Lymphoma
• Multiple Myeloma
• Plasma Cell Neoplasm
• Myelodysplastic Syndromes

Interventions

BIOLOGICAL

umbilical cord blood transplantation

Infusion of umbilical cord blood

DRUG

Allopurinol

Administration begins Day -7 through Day 0, tablet or powder prescribed on an individual basis.

DRUG

fludarabine phosphate

40 mg/m\^2 intravenously over 1 hour on Days -6, -5, -4, -3, -2

DRUG

Cyclophosphamide

50 mg/kg intravenous over 2 hours on Day -6

RADIATION

Total body irradiation

200 cGy on Day -1

BIOLOGICAL

Treg infusion

Infusion of T regulatory cells on Day +1 (also Day +15 for Dose level 5 only). Dose escalation ranges include 1, 3, 10, 30, 100, 300 1000, and 300 x 10\^5 Treg/kg.

DRUG

Sirolimus

Beginning on day -3 and continuing until day +100, patients receive sirolimus intravenously (IV) with 8-12 mg oral loading dose followed by a single dose of 4mg/day with a target serum concentration of 3-12 mg/mL with a taper until day +180.

Sponsors & Collaborators

• Masonic Cancer Center, University of Minnesota

  lead OTHER

Principal Investigators

• Claudio G. Brunstein, MD, PhD · Masonic Cancer Center, University of Minnesota

• Margaret L. MacMillan, MD · Masonic Cancer Center, University of Minnesota

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-07-23

Primary Completion

2014-09-25

Completion

2015-04-16

Countries

• United States

Study Locations