Thymoglobulin and Total Lymphoid Irradiation for Hematologic Malignancies

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT00476229
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Thymoglobulin — DRUG
    1.5 mg/kg by vein on Days -11 to -7.
  • Total Lymphoid Irradiation — RADIATION
    80 cGy daily on days -11 to -7 and -4 to 0.
  • Peripheral Blood Stem Cell Infusion — PROCEDURE
    PBSC infusion administered on day 0.
  • Rituximab — DRUG
    375 mg/m\^2 by vein on days -13, -6, 1, \& 8. Only those patients whose tumors express CD20 will receive Rituximab.

Study Details

Primary Objective: 1\. To determine whether the primary endpoint: the composite success rate, defined as the proportion of patients who are alive at day 100; and are without grade 3-4 Graft versus Host Disease (GVHD); and are without grade 4 toxicity (unrelated to infection); and have engrafted, is likely to be at least 40%. Secondary Objectives: 1. To determine the cumulative incidence of chronic graft versus host disease. 2. To determine the overall and disease free survival.

Key Dates

Start date
Jun 30, 2006
Status verified
Aug 2012
Primary completion
May 31, 2009
Completion
May 31, 2009

Study Design

Enrollment
20 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Radiation + Chemotherapy + BSCT
    Total Lymphoid Irradiation (2 times) at 80 cGy daily for five days + Thymoglobulin 1.5 mg/kg intravenous 5 days + Rituximab 375 mg/m\^2 intravenous on 4 different days + Blood stem cell transplant (BSCT)

Primary Outcome Measure

Composite Success Rate [ Time Frame: Baseline to Day 100, assessment at Day 100 ]

Locations (1)

FacilityCityStateZIPSite coordinators
U.T.M.D. Anderson Cancer CenterHoustonTexas77030-

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