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Prospective Phase II Study of Rabbit Antithymocyte Globulin (ATG, Thymoglobuline®, Genzyme) With Ciclosporin for Patients With Acquired Aplastic Anaemia

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ClinicalTrials.gov Identifier: NCT01530555
Recruitment Status : Completed
First Posted : February 10, 2012
Last Update Posted : February 25, 2016
Sponsor:
Information provided by (Responsible Party):
King Faisal Specialist Hospital & Research Center

Study Description
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Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Acquired Aplastic Anaemia Drug: Rabbit ATG, Thymoglobuline (Genzyme) Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Phase II Study of Rabbit Antithymocyte Globulin (ATG, Thymoglobuline®, Genzyme) With Ciclosporin for Patients With Acquired Aplastic Anaemia
Study Start Date : April 2008
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment arm
  1. Rabbit ATG, Thymoglobuline (Genzyme) 1.5 vials/10kg (3.75mg/kg) daily for 5 days given as an intravenous infusion over 12-18 hours.
  2. Ciclosporin (CSA) 5mg/kg/day orally from day +1 for a minimum of 6 months, with later tailing according to individual patient response. Aim to maintain trough whole blood CSA levels between 150 and 250 ng/ml.
 Drug: Rabbit ATG, Thymoglobuline (Genzyme)
  1. Rabbit ATG, Thymoglobuline® (Genzyme) 1.5 vials/10kg (3.75mg/kg) daily for 5 days given as an intravenous infusion over 12-18 hours.
  2. Ciclosporin (CSA) 5mg/kg/day orally from day +1 for a minimum of 6 months


Outcome Measures
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Primary Outcome Measures :
  1. Response [ Time Frame: 2 years ]
    Primary outcome is response at 6 months post ATG treatment


Secondary Outcome Measures :
  1. Over all survival [ Time Frame: 2 years ]
    Secondary outcome variables include overall survival and failure free survival at 2 years post ATG treatment


Eligibility Criteria
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Ages Eligible for Study:   16 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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
  2. Time from diagnosis to study registration ≤ 6mths
  3. No prior treatment except for haemopoietic growth factors given for no more than 4 weeks, and androgens.
  4. Age ≥ 16yrs (≥ 18yrs in Germany in accordance with German law), with no upper age limit.

Exclusion criteria:

  1. Eligibility for an HLA-matched sibling donor transplant for SAA patients
  2. Prior therapy with ATG or CSA
  3. Haematopoeitic growth factors more than 4 weeks before study enrollment
  4. Diagnosis of Fanconi anaemia, dyskeratosis congenita or congenital bone marrow failure syndrome
  5. Evidence of myelodysplastic disease
  6. Paroxysmal nocturnal haemoglobinuria with evidence of significant haemolysis, history of PNH associated thrombosis or a PNH clone > 50% by flow cytometry
  7. Diagnosis or previous history of carcinoma (except local cervical, basal cell, squamous cells, or melanoma)
  8. Subject is pregnant (e.g. positive HCG test) or is breast feeding
  9. Severe uncontrolled infection or unexplained fever > 38oC
  10. Subjects who have hepatic, renal cardiac, metabolic or other concurrent diseases of such severity that life expectancy is less than 3 months
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01530555


Sponsors and Collaborators
King Faisal Specialist Hospital & Research Center
Investigators
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Principal Investigator: Ahmed Al Zahrani, MD King Faisal Specialist Hospital & Research Center
More Information
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Responsible Party: King Faisal Specialist Hospital & Research Center
ClinicalTrials.gov Identifier: NCT01530555    
Other Study ID Numbers: 2081-005
First Posted: February 10, 2012    Key Record Dates
Last Update Posted: February 25, 2016
Last Verified: February 2012
Additional relevant MeSH terms:
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Anemia
Anemia, Aplastic
Hematologic Diseases
Bone Marrow Diseases
 Thymoglobulin
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents