Status:
COMPLETED
Thymoglobulin and Cyclosporine in Patients With Aplastic Anemia or Myelodysplastic Syndrome
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Genzyme, a Sanofi Company
Conditions:
Myelodysplastic Syndrome
Aplastic Anemia
Eligibility:
All Genders
15+ years
Phase:
PHASE2
Brief Summary
The goal of this clinical research study is to learn if combining the drugs thymoglobulin, methylprednisolone, cyclosporine, and G-CSF (NeupogenTM or NeulastaTM ) can help to control severe aplastic a...
Detailed Description
Aplastic anemia is a condition that involves a low level of red blood cells (anemia), white blood cells, and platelets without evidence of another bone marrow disease. Anemia leads to fatigue, shortne...
Eligibility Criteria
Inclusion
- Diagnosis of severe aplastic anemia (bone marrow cellularity \< 30%, with two of three peripheral counts at the time of initial presentation or currently low with absolute neutrophil count (ANC) \< 500/mL, pre-transfusion platelet (PLT) \< 20,000/mL, or pre-transfusion hemoglobin \< 8 g/dL and presence of no other underlying disorder.
- Diagnosis of MDS (World Health Organization) with bone marrow cellularity \< 30%, with two of three peripheral counts at the time of initial presentation or currently low with ANC \< 500/mL, pre-transfusion PLT \< 20,000/mL, or pre-transfusion hemoglobin \< 8 g/dL.
- Patients with MDS who have received prior biological therapy (not chemotherapy) are eligible. Hypomethylating agents and histone deacetylase inhibitors are considered as biological therapy.
- Age 15 or greater
- Adequate renal function (creatinine less than or equal to 2.0 mg/dL) unless related to the disease
- Adequate hepatic function (bilirubin less than or equal to 3.5 mg/dL) unless related to the disease
- No other investigational therapy in the past 14 days
- Able to sign consent form
- Able to comply with the need for contraception (abstinence, condom, birth control pill, or other acceptable form of contraception) during the entire study period
- Diagnosis of MDS (WHO) with bone marrow cellularity greater than 30%, with low or intermediate-1 risk by the International Prognostic Scoring System (IPSS) score, and requiring treatment (i.e. transfusion-dependent)
Exclusion
- Active and uncontrolled infection
- HIV positive test
- Pregnant or breast feeding
- Active and uncontrolled medical illness (pulmonary, cardiac, neurological, or other) that in the opinion of treating physician would likely interfere with study treatment
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT00806598
Start Date
May 1 2005
End Date
June 1 2012
Last Update
March 12 2013
Active Locations (1)
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1
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030