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Antithymocyte Globulin and Cyclosporine in Treating Low Risk Patients With Myelodysplastic Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00488436
Recruitment Status : Completed
First Posted : June 20, 2007
Last Update Posted : November 19, 2008
Information provided by:
PETHEMA Foundation

Brief Summary:
The different mechanisms of action between Antithymocyte globulin and cyclosporine can improve the effectivity when both are used in combination in patients with myelodysplastic syndrome.

Condition or disease Intervention/treatment Phase
Myelodysplastic Syndrome Drug: Antithymocyte globulin Drug: Cyclosporine Phase 4

Detailed Description:

Patients are treated with:

Antithymocyte globulin (Timoglobulin SangStat)

  • 2,5 mg/kg/day IV over 8 hours on days 1-4
  • Total dose: 10 mg/kg
  • Calculated dose adjusted to ideal weight
  • Especial considerations:

Paracetamol 1 gr (oral or IV) Dexclorfeniramine 5 mg IV Methylprednisolone 1 mg/kg IV 30 minutes before Timoglobulin and repeat if necessary at 4 hours - Platelet transfusion if platelet count is < 50 x 109/L

Cyclosporine (Sandimmun Neoral)

-2,5 mg/kg/12 h over 3 months

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: SMD/ATG-CSA: Antithymocyte Globulin and Cyclosporine in Treating Low Risk Patients With Myelodysplastic Syndrome
Study Start Date : May 2002
Actual Primary Completion Date : June 2007
Actual Study Completion Date : December 2007

Primary Outcome Measures :
  1. Compare the efficacy and toxicity of antithymocyte globulin and cyclosporine in patients with low risk myelodysplastic syndrome [ Time Frame: 3 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosis of low or intermediate risk myelodysplastic syndrome (MDS) (or high risk patient not eligible to intensive chemotherapy or for bone marrow transplantation), excluding chronic myelomonocytic leukemia
  • At less one of two following conditions:
  • Transfusion dependence: 1)Packed red blood cell transfusions greater than 2 times; 2)Untransfused hemoglobin level no greater than 10 g/dL; 3)Platelet transfusions greater than 1 time
  • Infection grade III or IV secondary to neutropenia
  • ECOG < or = 2

Exclusion Criteria:

  • Chronic myelomonocytic leukemia
  • Creatinine greater than 2 mg/dl
  • Bilirubin greater than 2.5 mg/dl
  • History of heart failure
  • History of allergy to rabbit proteins

Information from the National Library of Medicine

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 identifier (NCT number): NCT00488436

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Hospital de Cabueñes
Asturias, Spain
Hospital germans Trias i Pujol
Badalona, Spain
Hospital de Basurto
Bilbao, Spain
Hospital Ntra Sra del Rossell
Cartagena, Spain
Hospital Materno Infantil de Las Palmas
Las Palmas de Gran Canaria, Spain
Hospital Virgen de la Victoria
Malaga, Spain
Hospital Morales Messeguer
Murcia, Spain
Hospital de Navarra
Pamplona, Spain
Hospital Arnau de Vilanova
Valencia, Spain
Hospital Dr Pesset
Valencia, Spain
Hospital Clinico Universitario
Zaragoza, Spain
Sponsors and Collaborators
PETHEMA Foundation
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Study Director: Sanz Guillermo, Dr HOSPITAL LA FE VALENCIA
Study Director: Julia Antonio, Dr Hospital Vall d'Hebron Barcelona

Additional Information:

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Responsible Party: Pethema, pethema Identifier: NCT00488436     History of Changes
Other Study ID Numbers: SMD/ATG-CSA/2002
First Posted: June 20, 2007    Key Record Dates
Last Update Posted: November 19, 2008
Last Verified: November 2008

Keywords provided by PETHEMA Foundation:
Myelodysplastic Syndrome
Antithymocyte Globulin

Additional relevant MeSH terms:
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Myelodysplastic Syndromes
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Antilymphocyte Serum
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors