Randomized Double Cord Blood Transplant Study

Summary

The goal of this clinical research study is to learn if combining cord blood units to make the cells "take" faster in recipients will help to improve the results of cord blood transplants.

Conditions

• Leukemia, Lymphocytic, Acute
• Leukemia, Myelocytic, Acute
• Leukemia, Myeloid, Chronic
• Lymphoma, Non-Hodgkin

Interventions

PROCEDURE

Expanded allogeneic cord blood (CB)

Transplantation of Two Unmanipulated Cord Blood Units.

PROCEDURE

One Unmanipulated and One Expanded Cord Blood Unit

Transplantation of One Unmanipulated and One Expanded Cord Blood Unit.

DRUG

Rituxan

375 mg/m2 by vein on Day - 9 for patients with CD20 + malignancies.

DRUG

Melphalan

140 mg/m2 by vein on Day -8.

DRUG

Thiotepa

5 mg/Kg by vein on Day -7.

DRUG

Fludarabine

40 mg/m2 by vein on Days -6 to -3.

DRUG

Cyclophosphamide

50 mg/kg by vein on Day -6.

DRUG

Mesna

10 mg/kg by vein before the 1st dose of Cyclophosphamide, then 10 mg/kg every 4 hours for four more doses (total of 50 mg/Kg).

RADIATION

Total body irradiation (TBI)

Total body irradiation (TBI) given on Day -1 at 2 Gy.

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Cellgenix

  collaborator UNKNOWN

• M.D. Anderson Cancer Center

  lead OTHER

Principal Investigators

• Simrit Parmar, MD · M.D. Anderson Cancer Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

1 Month

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2003-04-30

Primary Completion

2016-07-31

Completion

2016-07-31

Countries

• United States

Study Locations