- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01530555
Prospective Phase II Study of Rabbit Antithymocyte Globulin (ATG, Thymoglobuline®, Genzyme) With Ciclosporin for Patients With Acquired Aplastic Anaemia
February 24, 2016 updated by: King Faisal Specialist Hospital & Research Center
To assess the tolerability and efficacy of rabbit antithymocyte globulin (ATG, Thymoglobuline®) with ciclosporin (CSA) in the first line treatment of patients with acquired severe aplastic anaemia (SAA), and patients with non-severe aplastic anaemia (NSAA) and who are transfusion dependent.
To compare the response rate of the combination of rabbit ATG (Thymoglobuline® and CSA from this pilot study with the response rate observed in a series of matched AA patients; treated after 1994 with the combination of horse ATG (Lymphoglobuline®) and CSA; obtained from the EBMT database (comparative study).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
35
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 78 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- To define aplastic anaemia there must be at least two of the following: (1) haemoglobin < 10g/dl; (2) platelet count < 50 x 109/l; (3) neutrophil count < 1.5 x 109/l, and a hypocellular bone marrow on bone marrow biopsy
- Time from diagnosis to study registration ≤ 6mths
- No prior treatment except for haemopoietic growth factors given for no more than 4 weeks, and androgens.
- Age ≥ 16yrs (≥ 18yrs in Germany in accordance with German law), with no upper age limit.
Exclusion criteria:
- Eligibility for an HLA-matched sibling donor transplant for SAA patients
- Prior therapy with ATG or CSA
- Haematopoeitic growth factors more than 4 weeks before study enrollment
- Diagnosis of Fanconi anaemia, dyskeratosis congenita or congenital bone marrow failure syndrome
- Evidence of myelodysplastic disease
- Paroxysmal nocturnal haemoglobinuria with evidence of significant haemolysis, history of PNH associated thrombosis or a PNH clone > 50% by flow cytometry
- Diagnosis or previous history of carcinoma (except local cervical, basal cell, squamous cells, or melanoma)
- Subject is pregnant (e.g. positive HCG test) or is breast feeding
- Severe uncontrolled infection or unexplained fever > 38oC
- Subjects who have hepatic, renal cardiac, metabolic or other concurrent diseases of such severity that life expectancy is less than 3 months
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment arm
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Response
Time Frame: 2 years
|
Primary outcome is response at 6 months post ATG treatment
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Over all survival
Time Frame: 2 years
|
Secondary outcome variables include overall survival and failure free survival at 2 years post ATG treatment
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Ahmed Al Zahrani, MD, King Faisal Specialist Hospital & Research Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2008
Primary Completion (Actual)
July 1, 2013
Study Completion (Actual)
July 1, 2013
Study Registration Dates
First Submitted
January 24, 2012
First Submitted That Met QC Criteria
February 9, 2012
First Posted (Estimate)
February 10, 2012
Study Record Updates
Last Update Posted (Estimate)
February 25, 2016
Last Update Submitted That Met QC Criteria
February 24, 2016
Last Verified
February 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2081-005
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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