Reduced Intensity Total Body Irradiation + Thymoglobulin Followed by Allogeneic PBSCT

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT00709592
First received: July 1, 2008
Last updated: April 10, 2014
Last verified: April 2014
  Purpose

One of two different doses of thymoglobulin will allow bone marrow engraftment with minimal Graft-versus-Host Disease and allow adequate immune response to allow the transplanted stem cells to replace the tumor cells.


Condition Intervention Phase
Non-Hodgkin's Lymphoma
Leukemia
Multiple Myeloma
Acute Myeloid Leukemia
Hodgkin Lymphoma
Chronic Lymphocytic Leukemia
Chronic Myelogenous Leukemia
Myelodysplastic Syndrome
Biological: thymoglobulin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Reduced Intensity Myeloablative Total Body Irradiation and Thymoglobulin Followed by Allogeneic Peripheral Blood Stem Cell Transplantation

Resource links provided by NLM:


Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • The primary endpoint of the study is a comparison of functional immune reconstitution at 6-9 months following transplant as measured by antibody response to vaccination with inactivated Hepatitis A or B vaccine. [ Time Frame: Up to 9 months following transplant ] [ Designated as safety issue: No ]
    A positive test result will indicate immune reconstitution, while a negative test results will indicate lack of immune reconstitution.


Secondary Outcome Measures:
  • Engraftment of donor hematopoietic stem cells, as measured by neutrophil and platelet counts [ Time Frame: Up to 52 weeks post-transplant ] [ Designated as safety issue: No ]
    Descriptive statistics at each time point by arm will be estimated. In addition, a mixed effects model predicting engraftment considering treatment arm as the fixed effect and patient as a random effect will be estimated using data available from all time points to assess for a difference between arms.


Estimated Enrollment: 90
Study Start Date: July 2008
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
1.7 mg/kg/d thymoglobulin IV d-9 to -7
Biological: thymoglobulin
1.7 mg/kg/day
Other Name: Antithymocyte Globulin (Rabbit)
Experimental: B
2.5 mg/kg/d thymoglobulin IV d-9 to d-7
Biological: thymoglobulin
2.5 mg/kg/day
Other Name: Antithymocyte Globulin (Rabbit)

Detailed Description:

This randomized phase II trial studies how well giving low dose total-body irradiation (TBI) with anti-thymocyte globulin followed by donor peripheral blood stem cell transplant (PBSCT) works in treating patients with hematologic malignancies. Giving reduced intensity total-body irradiation and anti-thymocyte globulin before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving total-body irradiation together with antithymocyte globulin before transplant may stop this from happening.

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with hematological malignancies for which allogeneic stem cell transplantation indicated including non-Hodgkin lymphoma (NHL), multiple myeloma (MM), acute myeloid leukemia (AML), Hodgkin lymphoma (HD), chronic lymphocytic leukemia (CLL), chronic myelogenous leukemia (CML), and myelodysplastic syndrome (MDS)
  • Patients with HLA compatible related or unrelated stem cell donor, willing and able to serve as an allogenic HSC donor. Unrelated donors have to be matched at HLA-A, B, C and DRB1 loci. A single locus mismatch will be tolerated in the event a more closely matched donor is not available.
  • Patients age >/=40 to </=70 with an ECOG performance status < 2
  • Patients between 18 and 40 years of age will be eligible only if they have co-morbidities precluding conventional allogeneic transplantation with full intensity myeloablative conditioning
  • Adequate cardiac, pulmonary, renal and hepatic function for transplant
  • Negative serology for HIV
  • Negative serum pregnancy test
  • Patients who have received therapeutic radiation to a localized field will be eligible, provided critical structure tolerance doses have not been exceeded
  • Patients who have had prior myeloablative autologous transplant will be eligible

Exclusion Criteria:

  • Evidence of uncontrolled viral, fungal, bacterial infection
  • Evidence of active meningeal or CNS disease
  • Prior therapy with rabbit ATG, prior treatment with equine ATG is allowed if more than 3 months ago
  • Breast feeding mothers are excluded
  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: NCT00709592

Locations
United States, Virginia
Massey Cancer Center/Virginia Commonwealth University
Richmond, Virginia, United States, 23298-0037
Sponsors and Collaborators
Virginia Commonwealth University
Genzyme, a Sanofi Company
Investigators
Principal Investigator: Amir Toor, MD Massey Cancer Center, VCU
  More Information

Additional Information:
No publications provided

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00709592     History of Changes
Other Study ID Numbers: MCC-11561
Study First Received: July 1, 2008
Last Updated: April 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Virginia Commonwealth University:
total body irradiation
Allogeneic Peripheral Blood Stem Cell Transplantation
thymoglobulin

Additional relevant MeSH terms:
Hodgkin Disease
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Lymphoma
Lymphoma, Non-Hodgkin
Multiple Myeloma
Neoplasms, Plasma Cell
Myelodysplastic Syndromes
Preleukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hemorrhagic Disorders
Precancerous Conditions

ClinicalTrials.gov processed this record on July 31, 2014