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Thymoglobulin and Total Lymphoid Irradiation for Hematologic Malignancies
This study is currently recruiting participants.
Verified by M.D. Anderson Cancer Center, December 2008
Sponsors and Collaborators: M.D. Anderson Cancer Center
Genzyme
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00476229
  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 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

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood Lymphoma
Drug Information available for: Rituximab Tacrolimus Mycophenolate Mofetil Mycophenolate mofetil hydrochloride Tacrolimus anhydrous
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Total Lymphoid Irradiation, Thymoglobulin, and Rituximab for Allogeneic Transplantation in Lymphoid Malignancies

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

Primary Outcome Measures:
  • To see if combining radiation therapy, chemotherapy, and a blood stem cell transplant can help to control certain types of leukemia or lymphoma. [ Time Frame: 4 Years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: June 2006
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Total Lymphoid Irradiation + Thymoglobulin + Rituximab
Drug: Thymoglobulin
1.5 mg/kg IV on Days -11 to -7.
Radiation: Total Lymphoid Irradiation
80 cGy daily on days -11 to -7 and -4 to 0.
Procedure: Peripheral Blood Stem Cell Infusion
PBSC infusion administered on day 0.
Drug: Rituximab
375 mg/m^2 IV on days -13, -6, 1, & 8. Only those patients whose tumors express CD20 will receive Rituximab.

  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 X upper limit of normal; serum bilirubin and alkaline phosphatase <3 X upper limit of normal.
  • Adequate pulmonary function with FEV1, FVC and DLCO >35% of expected corrected for hemoglobin. Exceptions may be allowed for patients with pulmonary involvement after discussing with PI.
  • Adequate cardiac function with left ventricular ejection fraction >35%. No uncontrolled arrhythmias or symptomatic cardiac disease.
  • Zubrod performance status <2
  • Patients must have an 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 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 CNS disease.
  • Evidence of acute or chronic active hepatitis or cirrhosis.
  • Uncontrolled infection, including Hepatitis B, C, HIV or HTLV-1 infection.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00476229

Contacts
Contact: Chitra M. Hosing, MD 713-792-8750

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

UT MD Anderson Cancer Center  This link exits the ClinicalTrials.gov site

Responsible Party: U.T.M.D. Anderson Cancer Center ( Chitra M. Hosing, MD/Assoc. Professor )
Study ID Numbers: 2005-0892
Study First Received: May 17, 2007
Last Updated: December 22, 2008
ClinicalTrials.gov Identifier: NCT00476229  
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

Study placed in the following topic categories:
Chronic lymphocytic leukemia
Leukemia, Lymphoid
Immunoproliferative Disorders
Hodgkin's disease
Rituximab
Leukemia, B-cell, chronic
Lymphoma, small cleaved-cell, diffuse
Tacrolimus
Antilymphocyte Serum
Leukemia
Lymphatic Diseases
Leukemia, Lymphocytic, Chronic, B-Cell
Mycophenolate mofetil
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma
Hodgkin Disease

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immunologic Factors
Immune System Diseases
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Antirheumatic Agents
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009