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

Information source: King Faisal Specialist Hospital & Research Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acquired Aplastic Anaemia

Intervention: Rabbit ATG, Thymoglobuline (Genzyme) (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: King Faisal Specialist Hospital & Research Center

Official(s) and/or principal investigator(s):
Ahmed Al Zahrani, MD, Principal Investigator, Affiliation: King Faisal Specialist Hospital & Research Center

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).

Clinical Details

Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Response

Secondary outcome: Over all survival

Eligibility

Minimum age: 16 Years. Maximum age: 80 Years. Gender(s): Both.

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

Locations and Contacts

Additional Information

Starting date: April 2008
Last updated: February 9, 2012

Page last updated: August 23, 2015

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