Cellular Therapy With Cord Blood Cells

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT00427557
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Fludarabine — DRUG
    30 mg/m\^2 by vein for 4 Days (Day -10 through Day -7).
  • Melphalan — DRUG
    140 mg/m\^2 by vein for 1 Day (Day -7).
  • Umbilical Cord Blood — PROCEDURE
    1 UCB Unit by vein on Day -5.
  • Rituximab — DRUG
    375 mg/m\^2 by vein once weekly (Days -7, -1, +7, +14) for 4 Weeks (if appropriate).
  • Peripheral Blood Stem Cell Infusion — OTHER
    Infusion of blood stem cells on Day 0.

Study Details

The goal of this clinical research study is to learn if giving umbilical cord blood along with standard stem cells after high-dose chemotherapy will improve the response to a stem cell transplant. The safety of this treatment will also be studied.

Key Dates

Start date
Oct 31, 2006
Status verified
May 2012
Primary completion
Nov 30, 2010
Completion
Nov 30, 2010

Study Design

Enrollment
31 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cellular Therapy with Cord Blood Cells
    Fludarabine 30 mg/m\^2 intravenous (IV) for 4 Days + Melphalan 140 mg/m\^2 IV for 1 Day + Rituximab 375 mg/m\^2 IV once weekly + Cord Blood Transplantation + Stem Cell Transplantation Infusion

Primary Outcome Measure

Number of Participants With Engraftment [ Time Frame: Baseline to 100 days post-engraftment ]

Locations (1)

FacilityCityStateZIPSite coordinators
UT MD Anderson Cancer CenterHoustonTexas77030-

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