Evaluating the Safety and Effectiveness of an Umbilical Cord Blood Stem Cell Transplant (BMT CTN 0604)

Summary

A bone marrow transplant, which is a type of stem cell transplant, is a treatment option for people with leukemia or lymphoma. Recently, stem cell transplants using umbilical cord blood have become a treatment option for people with these types of cancers. This study will evaluate the effectiveness of a stem cell transplant using umbilical cord blood, along with lower doses of chemotherapy, to treat people with leukemia or lymphoma.

Conditions

• Precursor B-Cell Lymphoblastic Leukemia-Lymphoma
• Leukemia, Myeloid, Acute
• Burkitt Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Follicular
• Lymphoma, Large B-Cell, Diffuse

Interventions

BIOLOGICAL

Hematopoietic Umbilical Cord Blood Stem Cell Transplantation

The transplant preparative regimen is listed below. The - sign is the number of days before the transplant. * Fludarabine: 40 mg/m\^2 intravenously (IV) on Days -6, -5, -4, -3, and -2 * Cyclophosphamide: 50 mg/kg IV on Day -6 * Total body irradiation: 200 centigray (cGy) on Day -1

BIOLOGICAL

GVHD prophylaxis

GVHD prophylaxis regimen will consist of: * Cyclosporine: beginning on Day -3 with the dose adjusted to maintain a level of 200-400 mg/mL * MMF: 1 gram IV three times a day (TID) if greater than 50 kg, or 15 mg/kg IV TID if less than 50 kg beginning on Day -3; continued until Day 30 or 7 days after engraftment, whichever day is later Day 0 is the day of the infusion of the umbilical cord blood graft units, which will be obtained from partially HLA-matched unrelated donors. Beginning on Day 1, participants will receive G-CSF 5 mcg/kg/day until absolute neutrophil count (ANC) is greater than or equal to 2,000/mm\^3 for three consecutive measurements, each on different days.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• Blood and Marrow Transplant Clinical Trials Network

  collaborator NETWORK

• National Cancer Institute (NCI)

  collaborator NIH

• National Marrow Donor Program

  collaborator OTHER

• Medical College of Wisconsin

  lead OTHER

Principal Investigators

• Mary Horowitz, MD, MS · Center for International Blood and Marrow Transplant Research (CIBMTR), Medical College of Wisconsin

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

1 Year

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-12-31

Primary Completion

2011-04-30

Completion

2013-11-30

Countries

• United States

Study Locations