Status:
TERMINATED
Thymoglobulin (ATG) Dose Finding Study
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Genzyme, a Sanofi Company
Conditions:
Graft vs Host Disease
Eligibility:
All Genders
Phase:
PHASE1
PHASE2
Brief Summary
Primary Objective: * To determine the response and toxicity rate at day 56 of two different dose levels of thymoglobulin (ATG) \[anti-thymocyte globulin (rabbit)\] as a treatment of steroid-refractor...
Detailed Description
GvHD is a common side effect of a stem cell transplant. It is caused by a type of white blood cell (a lymphocyte). ATG is designed to kill lymphocytes and is commonly used to help prevent or treat GvH...
Eligibility Criteria
Inclusion
- Patients who underwent their first allogeneic transplant for any malignancy and with any cell (bone marrow, peripheral stem cell, cord blood) or donor (matched or mismatched related or unrelated) source.
- Biopsy-proven, grade II-IV aGVHD following allogeneic hematopoietic stem cell transplantation (HSCT) of any source (bone marrow, peripheral blood or cord blood stem cells). Enrollment may be started prior to results of biopsy in cases of high clinical suspicion for aGVHD.
- Early steroid-refractory aGVHD. This is defined as any NR or PD after a minimum of 3 days and not more than 1 week of 1 mg/kg/day of methylprednisolone.
- Ability to sign informed consent.
- Ability to return for clinical follow-up as specified in the protocol.
- Inability to taper as defined by patients on \< or = 1 mg/kg/day of methylprednisolone but unable to further taper without resultant increase of acute GVHD stage.
- Patients with a reflare of a GVHD defined as worsening of 1 stage of acute GVHD in a patient who initially responded.
Exclusion
- Relapsed malignancy.
- Acute GVHD as a result of a second or subsequent transplant or donor lymphocyte infusion (DLI).
- Active, uncontrolled infection.
- Patients who have received any second-line of immunosuppressive treatment for GVHD beyond corticosteroids and calcineurin inhibitors. Topical steroids, oral budesonide and extracorporeal photochemotherapy started at the time of steroids are allowed.
- Life-threatening infusion reaction or hypersensitivity to any formulation of ATG in the past.
- Patients who are pregnant or are breast feeding.
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00409695
Start Date
December 1 2006
End Date
August 1 2007
Last Update
January 23 2012
Active Locations (1)
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1
U.T. M.D. Anderson Cancer Center
Houston, Texas, United States, 77030