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SMD/ATG-CSA: Antithymocyte Globulin and Cyclosporine in Treating Low Risk Patients With Myelodysplastic Syndrome


Phase 4
N/A
N/A
Not Enrolling
Both
Myelodysplastic Syndrome

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Trial Information

SMD/ATG-CSA: Antithymocyte Globulin and Cyclosporine in Treating Low Risk Patients With Myelodysplastic Syndrome


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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Compare the efficacy and toxicity of antithymocyte globulin and cyclosporine in patients with low risk myelodysplastic syndrome

Outcome Time Frame:

3 years

Principal Investigator

Sanz Guillermo, Dr

Investigator Role:

Study Director

Investigator Affiliation:

HOSPITAL LA FE VALENCIA

Authority:

Spain:Spanish Ministry of Health

Study ID:

SMD/ATG-CSA/2002

NCT ID:

NCT00488436

Start Date:

May 2002

Completion Date:

December 2007

Related Keywords:

  • Myelodysplastic Syndrome
  • Myelodysplastic Syndrome
  • Antithymocyte Globulin
  • Cyclosporine
  • Myelodysplastic Syndromes
  • Preleukemia

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