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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

Tracking Information
First Submitted Date  ICMJE January 24, 2012
First Posted Date  ICMJE February 10, 2012
Last Update Posted Date February 25, 2016
Study Start Date  ICMJE April 2008
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 9, 2012)
Response [ Time Frame: 2 years ]
Primary outcome is response at 6 months post ATG treatment
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 9, 2012)
Over all survival [ Time Frame: 2 years ]
Secondary outcome variables include overall survival and failure free survival at 2 years post ATG treatment
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prospective Phase II Study of Rabbit Antithymocyte Globulin (ATG, Thymoglobuline®, Genzyme) With Ciclosporin for Patients With Acquired Aplastic Anaemia
Official Title  ICMJE Prospective Phase II Study of Rabbit Antithymocyte Globulin (ATG, Thymoglobuline®, Genzyme) With Ciclosporin for Patients With Acquired Aplastic Anaemia
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acquired Aplastic Anaemia
Intervention  ICMJE 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
Study Arms  ICMJE 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.
Intervention: Drug: Rabbit ATG, Thymoglobuline (Genzyme)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 9, 2012)
35
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2013
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 80 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01530555
Other Study ID Numbers  ICMJE 2081-005
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party King Faisal Specialist Hospital & Research Center
Study Sponsor  ICMJE King Faisal Specialist Hospital & Research Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ahmed Al Zahrani, MD King Faisal Specialist Hospital & Research Center
PRS Account King Faisal Specialist Hospital & Research Center
Verification Date February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP