Thymoglobulin and Total Lymphoid Irradiation for Hematologic Malignancies

This study has been completed.
Sponsor:
Collaborator:
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00476229
First received: May 17, 2007
Last updated: August 1, 2012
Last verified: August 2012
  Purpose

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.

Condition Intervention
Lymphoma
Leukemia
Drug: Thymoglobulin
Radiation: Total Lymphoid Irradiation
Procedure: Peripheral Blood Stem Cell Infusion
Drug: Rituximab

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Total Lymphoid Irradiation, Thymoglobulin, and Rituximab for Allogeneic Transplantation in Lymphoid Malignancies

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Composite Success Rate [ Time Frame: Baseline to Day 100, assessment at Day 100 ] [ Designated as safety issue: No ]
    Defined as the proportions of the patients who are alive at day 100, are without Grade 3-4 Graft Graft-versus-host disease (GVHD), without Grade 4 toxicity (unrelated to infection) and have engrafted. Toxicity grades according to Common Toxicity Criteria (CTC) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0.


Enrollment: 20
Study Start Date: June 2006
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
Drug: Thymoglobulin
1.5 mg/kg by vein on Days -11 to -7.
Other Names:
  • Antithymocyte Globulin
  • ATG
Radiation: Total Lymphoid Irradiation
80 cGy daily on days -11 to -7 and -4 to 0.
Other Name: TLI
Procedure: Peripheral Blood Stem Cell Infusion
PBSC infusion administered on day 0.
Other Names:
  • Blood Stem Cell Transplant
  • BSCT
Drug: Rituximab
375 mg/m^2 by vein on days -13, -6, 1, & 8. Only those patients whose tumors express CD20 will receive Rituximab.
Other Name: Rituxan

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age up to 70 years.
  • Patients with lymphoid malignancies (primary refractory or recurrent) beyond first remission or unresponsive to therapy and not eligible for protocols of higher priority. Patients should have had at least a partial remission or have stable disease with prior chemotherapy. Patients with bulky disease (greatest dimension > 5 cm by radiographic or clinical examination are not eligible).
  • Adequate renal function, as defined by serum creatinine <1.8 mg/dL.
  • Adequate hepatic function, as defined by SGPT <3 times upper limit of normal; serum bilirubin and alkaline phosphatase <3 times upper limit of normal.
  • Adequate pulmonary function with Forced expiratory volume in one second (FEV1), forced vital capacity (FVC) and Carbon Monoxide Diffusing Capacity (DLCO) >35% of expected corrected for hemoglobin. Exceptions may be allowed for patients with pulmonary involvement after discussing with Principal Investigator.
  • Adequate cardiac function with left ventricular ejection fraction >35%. No uncontrolled arrhythmias or symptomatic cardiac disease.
  • Zubrod performance status <2
  • Patients must have an human leukocyte antigens (HLA) matched, or one A, B, C, DR, or DQ mismatched related or unrelated donor (by high resolution typing). Donor must be willing to donate peripheral blood progenitor cells.
  • Patient should be willing to participate in the study by providing written consent.
  • Negative beta human chorionic gonadotrophin (hCG) test in a woman of child bearing potential (defined as not post menopausal for 12 months or no previous surgical sterilization).

Exclusion Criteria:

  • Patients with active central nervous system (CNS) disease.
  • Evidence of acute or chronic active hepatitis or cirrhosis.
  • Uncontrolled infection, including Hepatitis B, C, Human immunodeficiency virus (HIV) or human T-cell lymphotropic virus type 1 (HTLV-1) infection.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00476229

Locations
United States, Texas
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Genzyme, a Sanofi Company
Investigators
Principal Investigator: Chitra M. Hosing, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00476229     History of Changes
Other Study ID Numbers: 2005-0892
Study First Received: May 17, 2007
Results First Received: July 13, 2011
Last Updated: August 1, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Non-Hodgkin's Lymphoma
Chronic Lymphocytic Leukemia
Hodgkin's Lymphoma
Lymphoma
Leukemia
Mycophenolate Mofetil
Tacrolimus
Thymoglobulin
Total Lymphoid Irradiation

Additional relevant MeSH terms:
Lymphoma
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Antilymphocyte Serum
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Immunosuppressive Agents

ClinicalTrials.gov processed this record on September 30, 2014