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

This study has been completed.
Sponsor:
Information provided by:
PETHEMA Foundation
ClinicalTrials.gov Identifier:
NCT00488436
First received: June 19, 2007
Last updated: November 17, 2008
Last verified: November 2008
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00488436

Locations
Spain
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 Dr Pesset
Valencia, Spain
Hospital Arnau de Vilanova
Valencia, Spain
Hospital Clinico Universitario
Zaragoza, Spain
Sponsors and Collaborators
PETHEMA Foundation
Investigators
Study Director: Sanz Guillermo, Dr HOSPITAL LA FE VALENCIA
Study Director: Julia Antonio, Dr Hospital Vall d'Hebron Barcelona
  More Information

Additional Information:
Publications:

Responsible Party: Pethema, pethema
ClinicalTrials.gov Identifier: NCT00488436     History of Changes
Other Study ID Numbers: SMD/ATG-CSA/2002
Study First Received: June 19, 2007
Last Updated: November 17, 2008
Health Authority: Spain:Spanish Ministry of Health

Keywords provided by PETHEMA Foundation:
Myelodysplastic Syndrome
Antithymocyte Globulin
Cyclosporine

Additional relevant MeSH terms:
Myelodysplastic Syndromes
Preleukemia
Syndrome
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms
Disease
Pathologic Processes
Cyclosporins
Cyclosporine
Antilymphocyte Serum
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on September 22, 2014