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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00806598 |
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Date of registration:
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09/12/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Thymoglobulin and Cyclosporine in Patients With Aplastic Anemia or Myelodysplastic Syndrome
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Scientific title:
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Phase II Study of Combination of Thymoglobulin, Cyclosporine, Methylprednisone, and Granulocyte Colony-stimulating Factor (GCSF) in Patients With Newly Diagnosed Aplastic Anemia or With Hypoplastic or Low/Intermediate-1 Risk Myelodysplastic Syndrome |
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Date of first enrolment:
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May 2005 |
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Target sample size:
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53 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00806598 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Tapan M. Kadia, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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M.D. Anderson Cancer Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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 Criteria:
- 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
Age minimum:
15 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Aplastic Anemia
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Myelodysplastic Syndrome
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Intervention(s)
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Drug: Thymoglobulin
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Drug: Methylprednisolone
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Drug: G-CSF
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Drug: Cyclosporine
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Primary Outcome(s)
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Overall Response
[Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first. Assessed first at 3 months on study, continuing monthly up to 3 years.]
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Secondary ID(s)
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2005-0115
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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