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

This study has been completed.
Information provided by:
PETHEMA Foundation Identifier:
First received: June 19, 2007
Last updated: November 17, 2008
Last verified: November 2008
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 Intervention Phase
Myelodysplastic Syndrome Drug: Antithymocyte globulin Drug: Cyclosporine Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by PETHEMA Foundation:

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

Estimated Enrollment: 25
Study Start Date: May 2002
Study Completion Date: December 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
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


Ages Eligible for Study:   Child, Adult, Senior
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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00488436

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
Study Director: Sanz Guillermo, Dr HOSPITAL LA FE VALENCIA
Study Director: Julia Antonio, Dr Hospital Vall d'Hebron Barcelona
  More Information

Additional Information:

Responsible Party: Pethema, pethema Identifier: NCT00488436     History of Changes
Other Study ID Numbers: SMD/ATG-CSA/2002
Study First Received: June 19, 2007
Last Updated: November 17, 2008

Keywords provided by PETHEMA Foundation:
Myelodysplastic Syndrome
Antithymocyte Globulin

Additional relevant MeSH terms:
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 processed this record on September 20, 2017